Pharmacology Blog

The March of Dimes is taking the best available thinking about how to prevent premature birth and putting it to the test. Together with the Johnson & Johnson Pediatric Institute, L.L.C., the March of Dimes will announce a Prematurity Prevention Initiative in Kentucky to see if bundling together proven interventions can lower a community’s rate of preventable preterm births.

Time: 10:30 a.m. press conference
Date: Tuesday Nov. 14
Place: Norton Suburban Hospital, Louisville

Prior to the press conference there will be a limited opportunity for the media to tour the hospital’s neonatal intensive care unit.

Speakers at the press conference will include:

*
Jon Cooper, associate vice president of Operations, Norton Suburban Hospital

* Dr. Jennifer L. Howse, president, March of Dimes

* Mark D. Birdwhistell, secretary, Kentucky Cabinet for Health & Family Services

* Jennifer Dickerson, who will tell her personal story of prematurity

* Dr. David R. Smith, president, State University of NY Upstate Medical University and

* March of Dimes Board of Trustees Prematurity Campaign

* Dr. Terry Cohen, Neonatologist

* Bonnie J. Petrauskas, director, Johnson & Johnson Pediatric Institute, L.L.C.

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Contact: Elizabeth Lynch

March of Dimes Birth Defects Foundation

The majority of U.S. adults, regardless of political affiliation, support a more balanced approach to sex education in schools, including teaching children about both abstinence and other methods of preventing pregnancy and sexually transmitted diseases, according to the results of a national survey published in the November issue of Archives of Pediatrics & Adolescent Medicine, one of the JAMA/Archives journals.

Young adults age 15 to 24 account for one-fourth of all sexually active individuals, according to background information in the article. However, they acquire about half of the new sexually transmitted disease (STD) infections–a total of 9 million infections, at a cost of $6.5 billion annually. One-fourth of youth have had sex by age 15, 37.5 by age 16 and 46.9 percent by age 17. “These data underscore the relevance of timely and informative sex education in middle and high schools as an important component to the public health goal of promoting safe behaviors and preventing additional infections and unintended pregnancies,” the authors write.

Amy Bleakley, Ph.D., M.P.H., and colleagues at the Annenberg Public Policy Center, Annenberg School for Communication, University of Pennsylvania, Philadelphia, analyzed data from 1,096 adults (average age 46.8, 46 percent men) who participated in the Annenberg National Health Communication Survey between July 2005 and January 2006. Respondents were asked about their support of three different types of sex education: abstinence-only, comprehensive and comprehensive that includes condom instruction. Participants also provided their political ideology on a seven-point scale from “extremely liberal” to “extremely conservative” as well as information about how often they attended religious services. Among the participants, 78.7 percent were white, 9.6 percent were black and 7.6 percent were Hispanic; 39.5 percent identified themselves as politically moderate, 35.5 percent as conservative and 25 percent as liberal.

Overall, 80.4 percent of participants said they believed comprehensive programs were an effective way to prevent unplanned pregnancies, compared with 39 percent who said they believed abstinence-only programs were effective. Eighty-two percent of participants said they supported comprehensive sex education programs and 10 percent opposed them; 68.5 percent supported and 21 percent opposed condom instruction; and 36 percent supported and 50 percent opposed abstinence-only programs. The researchers further broke down results by political affiliation and religious behavior and found the following:

* 91.6 percent of liberals, 86.4 percent of moderates and 70 percent of conservatives supported comprehensive (also known as abstinence plus) programs, while 19 percent of conservatives, 5.3 percent of moderates and 3.7 percent of liberals opposed them

* 47 percent of conservatives supported abstinence-only education, while 67 percent of liberals, 50.4 percent of moderates and 39.9 percent of conservatives opposed it

* 37.5 percent of conservatives, 13.4 percent of moderates and 9.1 percent of liberals opposed condom instruction, while 51.2 percent of conservatives supported it; among all respondents, 57 percent disagreed that condom instruction encourages teens to have sex

* 87.4 percent of those who never attend religious services support comprehensive programs

* Among those who attend religious services more than once per week, 60.3 percent supported abstinence-only and 60.3 percent supported abstinence plus programs; 52.6 percent opposed and 37.9 percent supported condom instruction

* 31.3 percent of those who attend religious services more than once per week and 57.9 percent of those who never attend services oppose abstinence-only education

“The federal government’s support of abstinence-only education is in contrast to the broad public and scientific support for comprehensive sex education demonstrated by our research review and study results. This discrepancy in the realm of sex education highlights a gap between science and policy. Sex education in schools is clearly a politically charged issue, but public opinion in this instance offers an opportunity to diffuse some of the inherent tension between science and policymaking,” the authors conclude. “With such high support for comprehensive sex education among the public from liberals, conservatives and moderates alike, political leaders could capitalize on this rare occasion to enact public policy that is supported by both sound scientific evidence as well as public opinion.”

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(Arch Pediatr Adolesc Med. 2006;160:1151-1156.)

Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Current Evidence Supports Comprehensive Sex Education

Abstinence-only sex education programs have received a large amount of federal funding in recent years, despite the lack of research supporting their effectiveness, writes Douglas Kirby, Ph.D., ETR Associates, Scotts Valley, Calif., in an accompanying editorial.

“To the extent that unproven abstinence-only programs have displaced effective comprehensive programs, the abstinence-only funding may have had much less effect on the behavior of youth than its supporters have hoped,” Dr. Kirby writes. “In fact, it is even possible that by making the funds so restrictive, they had the opposite effect intended.”

That does not mean that abstinence-only programs could not be effective, he continues. Such programs deserve further study, and all forms of sex education that succeed in delaying sex and increasing condom and other contraceptive use among young people should be considered for funding.

(Arch Pediatr Adolesc Med. 2006;160:1182-1184.)

Please see the article for additional information, including author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Susan Q. Stranahan
JAMA and Archives Journals

Traumatic events in childhood and stress or emotional instability at any period in life may be associated with the development of chronic fatigue syndrome (CFS), according to two articles in the November issue of Archives of General Psychiatry, one of the JAMA/Archives journals. The findings suggest that CFS and similar illnesses may result from the brain’s inability to cope with challenging experiences.

CFS affects between 400,000 and 900,000 U.S. adults, according to background information in the article. The condition is defined as unexplained fatigue that lasts for at least six months, does not get better with rest and interferes with daily activities. For a formal diagnosis of CFS, fatigue must be accompanied by at least four of eight additional symptoms, including extreme fatigue after exertion, difficulties with memory and concentration, unrefreshing sleep, headaches, muscle pain, joint pain, sore throat and tender lymph nodes. “Despite the substantial public burden of CFS, the causes and pathophysiology [underlying changes] of CFS remain unknown, and effective prevention is elusive,” the authors of the first article write.

Christine Heim, Ph.D., Centers for Disease Control and Prevention and Emory University, Atlanta, and colleagues compared 43 individuals with CFS to 60 controls without CFS who were all part of a large study of Wichita, Kansas, residents. All participants (average age 50.5) underwent a medical examination and provided their medical history, and were interviewed to detect psychiatric disorders. They then responded to a questionnaire that assessed for five types of childhood trauma: emotional, physical and sexual abuse and emotional and physical neglect. Responses to each item were numbered and added to produce a score for each type of trauma and one overall trauma score.

Individuals with CFS had higher overall trauma scores than those without CFS. Exposure to trauma increased the risk of CFS between three and eight times, depending on the type; emotional neglect and sexual abuse during childhood were most strongly associated with CFS. For each additional type of childhood trauma experienced, the risk of having CRS increased by 77 percent; the risk increased by 6 percent for each additional point increase in total trauma score. Not all patients with CFS had experienced childhood trauma, but those who had tended to have worse symptoms than those who had not.

CFS patients were also more likely than controls to have psychiatric disorders, including depression, anxiety and post-traumatic stress disorder. These conditions appeared to be associated with childhood trauma. “In sum, it appears that CFS is part of a spectrum of disorders that are associated with childhood adversity,” the authors write. “In adulthood, these disorders frequently manifest or worsen in relation to an acute stress or challenge. High emotional reactivity is a risk factor for all of these disorders. Thus, enhanced stress and mood reactivity can be assumed to be a central feature common to this spectrum of disorders.

“In fact, these disorders might reflect the brain’s inability to adapt or compensate in response to challenge, leading toward maladaptive responses and ultimately disease,” they conclude.

In the second study, Kenji Kato, Ph.D., Karolinska Institutet, Stockholm, Sweden, and colleagues assessed 19,192 Swedish twins born between 1935 and 1958, 1,570 of whom had chronic fatigue. Of those, 1,120 were impaired by their fatigue and 447 had the necessary four additional symptoms of CFS; these two groups were categorized as having CFS for the purposes of the study. Between 1972 and 1973, all participants answered questions about their personalities–which researchers assessed in terms of emotional stability and extraversion–and one question about stress: “Do you experience your daily existence as being very ‘stress filled’?” Three analyses were performed: One that matched each of the 1,567 individuals with CFS to individuals of the same age and sex without CFS; one that compared those with CFS to their twins without CFS, regardless of whether twins were identical or fraternal; and one that compared only identical twins with CFS to their co-twins without CFS.

In the first two analyses, emotional instability–defined as “an individual’s tendency to experience psychological distress that can be reliably measured by self-report and is relatively stable in an individual over time”–and stress were associated with CFS, while extraversion was not. In the age- and sex-matched comparison, individuals who reported that their life was stressful were 64 to 65 percent more likely to develop CFS; in the analysis comparing twins, the risk increased to 500 percent. “This suggests that some genes may serve as a buffering effect whereas other sensitive individuals are more susceptible to the impact of stress,” the authors write.

When only identical twins were assessed, emotional instability was not linked to risk for CFS, indicating that similar genetic factors underlie both conditions. “In contrast to stress, the association between emotional instability and fatigue is more likely to be endogenous,” or without an external cause, the authors continue. “Because we found considerable influences attributable to genetic and early environmental factors, our results suggest biological mechanisms that mediate the relationship between emotional instability and chronic fatigue. Likely candidates are those genes related to neurotransmission that have been implicated in depression and emotional instability.”

“These findings suggest plausible mechanisms for chronic fatiguing illness,” they conclude.

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(Arch Gen Psychiatry. 2006;63:1258-1266 and 1267-1272.)

Please see the articles for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Kathi Baker
JAMA and Archives Journals

The substantial number of today’s adolescents struggling with weak literacy skills presents an urgent national concern, yet very little is known about reading disabilities beyond the early elementary grades. To address this critical gap in knowledge, the Kennedy Krieger Institute has been awarded a $9 million grant from the National Institute of Health (N.I.H.) to establish a Learning Disabilities Research Center. The new center is among only four centers awarded in the country. The Center at the Kennedy Krieger Institute will undertake projects to illuminate the neurobiological and behavioral underpinnings of learning disabilities in children grades three through eight. By gaining a deep understanding of learning disabilities in these children, more effective educational interventions can be developed to improve the country’s literacy.

According to the National Assessment of Educational Progress (NAEP), only 33 percent of the nation’s eighth graders read at a “proficient” level and as many as 41 percent read only at “basic” level. A basic reading level involves mainly literal understanding and limited interpretation of grade appropriate text. Drawing on the diverse talents of researchers from the Kennedy Krieger Institute, Haskins Laboratories, Educational Testing Services and University of Maryland, the Center will undertake a variety of projects to improve our understanding of what is going wrong in struggling students, and provide insights into how they can be helped through instruction. These projects will:

* examine the word and text fluency of children and the ways in which they correlate with reading comprehension;

* examine the effectiveness of Response-to-Intervention (RTI) as a way of identifying children with reading disabilities, and use MRI scans to determine if there are neurocognitive indicators that predict how children will respond to intervention;

* determine how aspects of ADHD (processing speed, working memory) influence reading comprehension;

* and, determine the prevalence of different subtypes of reading disabilities by building upon the knowledge gained from the above projects.

One particular focus of the Center will be an examination of the phenomenon known as the “fourth grade slump,” whereby children who were successful learners in the primary grades begin to show achievement declines at grade four. It is widely recognized that this descent occurs at the precise time when classroom instruction shifts from teaching and practicing “bottom up” skills (basic word recognition and decoding) to “top down” skills (fluency and comprehension of content). While it is increasingly acknowledged that the leap from “bottom up” to “top down” skills is not automatic as once presumed, the roots of this problem remain largely a mystery.

“The research in this area of learning disabilities is minimal, and the need for answers is urgent,” explains Laurie Cutting, Ph.D, a research scientist at Kennedy Krieger Institute who specializes in the brain-behavior relationship in children with learning disabilities. “With this generous grant from the N.I.H., we can contribute substantially to an understanding of adolescent literacy in ways that will translate into practical applications for educators.”

Dr. Martha Denckla, Director of the Developmental Cognitive Neurology Clinic at the Kennedy Krieger Institute adds that, “As a result of this research initiative, we will now also begin to better understand the causes of the academic declines seen clinically with Attention Deficit Hyperactivity Disorder.”

Federal agencies, including the NIH and the Department of Education, have taken heed of the grim national literacy statistics and are devoting increased attention to tackling the issue on multiple fronts. Just last month, the Department of Education issued new regulations for aligning the definitions of “learning disabilities” in the Individuals with Disabilities Education Act (IDEA) and the No Child Left Behind Act (NCLB), underscoring the need for establishing uniform criteria as a starting point for accurate assessment. The N.I.H. grant awarded to Kennedy Krieger is further testament to the national attention being paid to learning disabilities.

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About Learning Disabilities
Learning disabilities are disorders that affect the ability to understand or use spoken or written language, do mathematical calculations, coordinate movements, or direct attention. Although learning disabilities occur in very young children, the disorders are usually not recognized until the child reaches school age and can be lifelong conditions. It is crucial to recognize and treat these challenges as soon as possible to ensure long-term success in the education of the child.

About the Kennedy Krieger Institute
Internationally recognized for improving the lives of children and adolescents with disorders and injuries of the brain and spinal cord, the Kennedy Krieger Institute in Baltimore, MD serves more than 12,000 individuals each year through inpatient and outpatient clinics, home and community services and school-based programs. Kennedy Krieger provides a wide range of services for children with developmental concerns mild to severe, and is home to a team of investigators who are contributing to the understanding of how disorders develop while pioneering new interventions and earlier diagnosis. For more information about Kennedy Krieger Institute, visit kennedykrieger/.

Contact: Lauren Wilson

Kennedy Krieger Institute

Healthcare professionals need to develop greater understanding of the quality of life issues facing the growing number of children who use a portable mechanical ventilator to help them breathe, according to research in the latest Journal of Advanced Nursing.

The six-year study – which asked children and parents for their views – discovered that most of the under 18s create their own ventilator-dependent lifestyles and have a good quality of life, but low self esteem and social exclusion remain major problems.

Professor Jane Noyes from the University of Wales, Bangor, carried out in-depth interviews with 35 ventilator-dependent children, together with 50 mothers and 17 fathers. A third of the 53 children included in the study, who ranged from one to 18 years-old, had received spinal or head injuries. The remainder had congenital conditions.

Professor Noyes found that the children’s health improved when they were ventilated and that they were able to experience life more fully if they had sufficient breath.

“I have better speech, I can taste better, smell better” said an eight year-old on 24-hour ventilation via a tracheostomy. And a teenager who had just acquired a car under a motability scheme spoke of how he wanted to pass his test and “do everything everybody else does.”

Spending less time in hospital and feeling less tired were other positive benefits of home ventilation.

The level of ventilator use appeared to have no bearing on children’s perception of their overall health, but it did have an impact on their quality of life.

Some children didn’t realise that their life was that different from non-ventilated children, while others realised that children who didn’t need to use a ventilator enjoyed far more freedom and varied life experiences than they did.

Parents were particularly aware of how socially excluded their children were.

Children who were being ventilated as a result of a serious illness or accident were particularly depressed at the way people now viewed them as a ‘ventilator-dependent’ child and angry at the many barriers that prevented them from taking part in the activities they once enjoyed.

Adjusting to home and school life again could be particularly difficult.

“It was a real shock because everyone was so looking forward to me coming home and we didn’t think about what it would be like when I actually got home” said one teenager after a serious accident. “I tried to go back to school, I went back for two days and I just couldn’t do it. I was just so upset that everything had changed.”

Another was upset that friends had drifted away. “They used to come here every day – but now they don’t. I wanted to be friends but they didn’t.”

In contrast, children who had depended on ventilation for all or most of their lives, and knew nothing different, appeared to have adapted to their circumstances. However, many still disliked being treated differently to non-ventilated children.

Children in the study generally associated a good life with a number of quality of life experiences, including:

* Being treated with respect
* Being able to communicate effectively
* Being able to live at home in quality housing
* Receiving quality services
* Being able to get out of the home and take holidays
* Having a good social life
* Receiving a good education and
* Being able to make decisions and gain independence.

But they needed greater support to achieve many of these aspirations and the homecare services they received didn’t address all of them. Not having a family car was a particular issue when it came to social exclusion.

Greater understanding of the needs and aspirations of ventilator-dependent children and their parents is essential, concludes Professor Noyes, especially as the situation is increasingly common due to recent medical advances and the increased use and availability of portable ventilators.

“The acceptance of children’s dependence on machines to live has brought about the need for nursing, medical, social and biological boundaries to be redefined, especially around children’s meanings of health, what they understand to be good quality of life and what they need to achieve it” she says.

“There are many ethical and funding issues surrounding the resources made available to ventilator dependent children.

“While these findings are unlikely to be helpful in complex legal cases – where the courts have to decide if a child should be treated with assisted ventilation – they do provide healthcare professionals with children’s insights, which evidence suggests may be different from their own”.

“The findings concur with current UK children’s healthcare policy that higher quality, more flexible and better co-ordinated nurse-led homecare is likely to improve the quality of life of ventilator-dependent children and maximise health gain.

“However the services provided must recognise the needs and aspirations of children and parents in this increasingly common area of healthcare.”

The children featured in the six-year study lived in a number of locations throughout the UK.

They covered a wide age range – 11 were under five, 24 were aged six to 12 and 18 were teenagers. A quarter were from single parent families, a quarter were from ethnic minority groups and six per cent were in care.

Some needed to be ventilated 24-hours a day, while other only needed to be ventilated overnight or when they were asleep. Ventilator use frequently increased during periods of acute illness.

A range of methods were adopted to overcome communication difficulties during interviews, including encouraging children to express their views by drawing, playing and using their computers. This ensured that a wide range of views and conditions were represented in the findings.

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* Health and quality of life in ventilator-dependent children. Noyes, J. Journal of Advanced Nursing. Volume 56.4, pages 392 to 403.

* Journal of Advanced Nursing, which is celebrating its 30th anniversary in 2006, is read by experienced nurses, midwives, health visitors and advanced nursing students in over 80 countries. It informs, educates, explores, debates and challenges the foundations of nursing health care knowledge and practice worldwide. Edited by Professor Alison Tierney, it is published 24 times a year by Blackwell Publishing Ltd, part of the international Blackwell Publishing group. journalofadvancednursing/

Contact: Annette Whibley

Blackwell Publishing Ltd.

Children as young as five to seven years of age prefer lucky individuals over the less fortunate, according to new research by psychologists at Harvard University and Stanford University. This phenomenon, the researchers say, could clarify the origins of human attitudes toward differing social groups and help explain the persistence of social inequality.

The work, by Kristina R. Olson and colleagues, is published in the latest issue of the journal Psychological Science.

“The hand of fate touches us all: Hurricanes strike some houses and spare others, lotteries are won and lost, and children are born into wealthy and poor families,” says Olson, a Harvard graduate student in psychology. “We set out to study how children make sense of random events, such as Hurricane Katrina, and how they feel about the people affected by such random events. Understanding how children think about others who experience luck or misfortune can provide a window into the origins of attitudes and preferences toward social groups that vary in privilege.”

Olson and her colleagues tested 32 children’s preferences among advantaged versus disadvantaged individuals. Their study also differentiated between events that occurred by chance and those that followed some intentional act. Thus, the youngsters were asked to evaluate actors in four types of scenarios: intentional and positive (such as a child who helped the teacher), intentional and negative (such as a child who lied to his or her mother), uncontrollable and positive (such as a child who found $5 on the sidewalk), or uncontrollable and negative (such as a child whose soccer game got rained out).

The children responded to 10 scenarios, rating how much they liked the child in each on a scale of 1 to 6. Not surprisingly, children showed a preference for intentional good actors (average score = 5.2) over intentional bad actors (average score = 1.7). But they also showed a striking preference for beneficiaries of uncontrollable good events (average score = 4.8) over victims of uncontrollable bad events (average score = 3.2). The children distinguished between intentional and uncontrollable events, showing a preference for uncontrollable bad actors over intentional bad actors, but only a marginal preference for intentional good actors over uncontrollable good actors.

“If the children were equally disposed toward the lucky and the unlucky, you would expect equivalent opinions of individuals affected by both positive and negative random events,” Olson notes. “The discrepancy in opinions of the beneficiaries of good luck versus the victims of bad luck indicates that children prefer fortunate individuals over unfortunate individuals.”

A second experiment by Olson and colleagues investigated whether this preference for the lucky spreads to new members of a group. Forty-three children were introduced to two five-member groups distinguished only by their shirt color and location on a computer screen. Three members of one group were described as beneficiaries of uncontrollable positive events, whereas three members of the other group were described as the victims of uncontrollable negative events.

Subjects were then introduced to a new member of each group and were asked which they liked more. The children were more likely to prefer new individuals who belonged to the mostly lucky group, despite the fact that they had no knowledge of the new member other than an arbitrary group affiliation based on shirt color.

“Our experiments show the difficulties that confront youngsters as they make judgments of those touched by luck or misfortune,” Olson says. “Young children express stronger liking for the beneficiaries of good luck compared to the victims of bad lack and generalize this preference to those who share membership in a group. Because the disadvantaged are more likely to experience negative events beyond their control — such as the tendency for the poor to be most impacted by natural disasters — this innocuous preference for the privileged may eventually grow more harmful, further increasing negativity toward the disadvantaged. Such preferences may, in turn, help explain the persistence of social inequality.”

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Olson’s co-authors on the Psychological Science paper are Mahzarin R. Banaji and Elizabeth S. Spelke of Harvard’s Department of Psychology and Carol S. Dweck of Stanford. Their work was funded by the National Institutes of Health, the National Science Foundation, the Beinecke Scholarship at Harvard, and Third Millennium Foundation.

Contact: Steve Bradt

Harvard University

Exposure limits for chemicals should be set at values that recognise the unique sensitivity of pregnant women and young children, and they should aim to protect brain development, according to a Review this week.

Neurodevelopmental disorders such as autism, attention deficit disorder, and cerebral palsy are common, costly and can cause lifelong disability. One in every six children has a developmental disability and in most cases these disabilities affect the nervous system. The two main obstacles to preventing neurodevelopmental disabilities caused by chemicals are the great gaps in testing chemicals for developmental neurotoxicity and the high level of proof required for regulation.

A few industrial chemicals such as lead are recognised causes of neurodevelopmental disorders. Exposure to these chemicals during early fetal development can cause brain injury at doses much lower than those affecting adults. Recognition of these risks has given rise to evidence-based programmes of prevention, such as elimination of lead additives in petrol. Although, these campaigns are highly successful, most were initiated only after substantial delays, state Dr Philippe Grandjean (Department of Environmental Medicine, University of Southern Denmark, Odense, Denmark) and Dr. Philip Landrigan (Department of Community Medicine, Mount Sinai School of Medicine, New York, NY, USA).

In the EU, 100 000 chemicals were registered for commercial use in 1981 and in the USA 80 000 are registered. Of the chemicals most commonly used in commerce, fewer than half have been subjected to even token laboratory testing. The few substances proven to be toxic to human neurodevelopment should therefore be viewed as the tip of a very large iceberg.

Dr Grandjean concludes: “The vulnerability of the human nervous system and its special susceptibility during early development suggest that protection of the developing brain should be a paramount goal of public health protection.

A precautionary approach, which is now beginning to be used in the EU, would mean that early indications of a potential for a serious toxic effect, such as developmental neurotoxicity, should lead to strict regulation, which could be relaxed, should subsequent documentation show less harm than anticipated”.

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Contact: Dr Philippe Grandjean, Department of Environmental Medicine, University of Southern Denmark, Winslowparken 17, 5000 Odense C, Denmark .

Contact: Joe Santangelo

Lancet

Anesiva,
Inc. (Nasdaq: ANSV) announced the publication of data in Pediatrics,
the journal of the American Academy of Pediatrics, from a Phase 3 trial of
Zingo(TM) (lidocaine hydrochloride monohydrate) powder intradermal
injection, the company’s fast-acting, topical, needle-free local
anesthetic, that showed treatment with Zingo was associated with
significantly less pain during intravenous (IV) line placement or
venipuncture as compared to sham placebo.(1) The study is the largest trial
published to date on local anesthetic use for peripheral venous access
procedures in children.

“Increased use of topical local anesthetics has long been urged to
reduce peripheral venous access pain in children, but use of those tools
has been limited by slow onset of action,” said William T. Zempsky, M.D.,
Associate Professor, Department of Pediatrics, University of Connecticut;
Associate Director, Pain Relief Program, Connecticut Children’s Medical
Center, Hartford, who led the pediatric clinical trials of Zingo. “As
demonstrated in the Phase 3 trial, Zingo’s rapid action is a leap forward
in the control of peripheral venous access pain management for children.”

More than 18 million children undergo venous access procedures,
including blood draws and IV insertions, in U.S. hospitals each year.(2) In
addition to the commonality of venous access procedures, they are also a
source of pain for children.(3) According to a study published in the
journal Pediatric Nursing, IV insertions and blood draws are the most
frequently reported painful events in hospitalized children.(3) Another
study shows that more than a third of children (36%) report having moderate
to severe pain during blood draws.(4)

This Phase 3 study, called COMFORT-003 (Comparison of Venipuncture and
Venous Cannulation Pain After Fast-Onset Needle-free Powder Lidocaine or
Placebo Treatment), demonstrated Zingo’s rapid onset of action, allowing
peripheral venous access procedures, such as IV insertions or blood draws,
to begin one to three minutes after administration.(1) Guidelines from the
American Academy of Pediatrics, the American Pain Society and the Infusion
Nurses Society have all recommended use of topical anesthetics prior to
venous access procedures(5), but since many currently available local
anesthetics take 20 minutes or longer to become effective, they’re often
difficult to use in a fast-paced hospital environment. According to a
national survey of Pediatric Emergency Department Fellowship Directors,
current topical anesthetics are used for only 38 percent of IV placements
in children.(6)

The study was a randomized, double-blind, placebo-controlled,
single-dose, Phase 3 study to assess efficacy and safety. It compared 292
patients from age three to 18 who received Zingo with a group of 287
patients who were treated with a sham placebo device that did not
administer medication.(1)

Zingo demonstrated a statistically significant reduction in pain by all
measures studied.

– Patients receiving Zingo reported less pain (1.77) compared to
patients in the control group (2.10) by children’s self report using
the Wong-Baker Faces scale (p=0.011).

– A secondary measure of pain, the visual analog scale (VAS), was also
used in patients eight to 18 years old, and patients who received
Zingo also reported significantly lower VAS scores (22.62) compared to
sham placebo (31.97) (p

University of Utah biologists invented a chemical-free, hairdryer-like device – the LouseBuster – and conducted a study showing it eradicates head lice infestations on children by exterminating the eggs or “nits” and killing enough lice to prevent them from reproducing.

The study – published in the November 2006 issue of the journal Pediatrics – “shows our invention has considerable promise for curing head lice,” says Dale Clayton, a University of Utah biology professor who led the research and co-invented the machine.

“It is particularly effective because it kills louse eggs, which chemical treatments have never done very well,” he says. “It also kills hatched lice well enough to eliminate entire infestations. It works in one 30-minute treatment. The chemical treatments require multiple applications one to two weeks apart.”

The LouseBuster now is in early stages of commercial development by a University of Utah spinoff company, Larada Sciences, for which Clayton is chief scientific officer. Patents are pending on the LouseBuster technology, which Clayton hopes will be on the market within two years for use in schools and clinics.

“Each year, millions of children are infested with head lice, a condition known as pediculosis, which is responsible for tens of millions of lost school days,” the study’s authors write. “Head lice have evolved resistance to many of the currently used pediculicides [insecticide shampoos]. … Hot air is an effective, safe treatment and one to which lice are unlikely to evolve resistance.”

The device blows warm air through a flexible hose, which has a rake-like hand piece on the end. It apparently kills lice and nits by drying them out, not by heating them. Clayton urges parents not to use hair dryers to try to kill head lice.

“We don’t want kids getting burned by parents who think it’s the heat” that kills lice, he says. “This thing is actually cooler than a hair dryer, but requires twice as much air flow, and the special hand piece is critical because, unless you expose the roots of the hair, it doesn’t work. And it’s difficult to do that with a regular comb.”

Clayton conducted the study with Brad Goates, a University of Utah medical student who wrote his master’s thesis about the LouseBuster; Joseph Atkin, Kevin Wilding, Kurtis Birch and Michael Cottam, all of whom worked in Clayton’s lab as undergraduates; and Sarah Bush, who is Clayton’s wife and co-directs the Center for Alternate Strategies of Parasite Removal, a state-funded Center of Excellence working to commercialize the LouseBuster. Clayton, Atkin and Wilding co-invented the device.

How Hot-Air Treatments for Lice Were Studied

“The cool thing about the machine is, it works – unlike many other treatments that haven’t been rigorously tested,” Clayton says. “It came out of basic research, completely unplanned.”

Clayton’s research focuses on birds and the lice that infest them. But when he moved to the University of Utah in 1996, he couldn’t keep lice alive on laboratory birds because Utah’s air was too dry. He had to humidify bird rooms to keep lice alive.

About the same time, his two children – Mimi and Roger, now 13 and 15, respectively – got head lice, “and we wondered if there was a way to kill head lice by drying them out,” Clayton says. “We started trying different methods of desiccation using hot air like conventional hair dryers, but those didn’t work well.”

In the new study, the researchers tested six ways of applying hot air to children’s lice-infested scalps. The tests were conducted during 2001-2005 on 169 infested children who were solicited for the study by flyers distributed in dozens of Salt Lake Valley schools. The study was approved by the university’s Institutional Review Board, which reviews research involving human subjects. Parents and children signed consent forms.

Children were excluded from the study if they had used other head lice treatments within the previous two weeks. Clayton dispatched his students in pairs to the homes of infested children to test the various methods. After completion of each treatment trial, each participant was paid $10 and given conventional treatments for lice.

Some 94 percent of the children were girls, who are more likely to have bad infestations because their hair is longer and they have more head-to-head contact on the playground, Clayton says.

Before treatment, the researchers combed one side of each child’s head to remove all visible lice and nits, which were placed in an incubator. Then, the entire scalp was treated with one of the six methods being tested. After treatment, the other side of the scalp was combed for the same amount of time as the first side, with removed lice and nits also placed in an incubator.

The researchers used a dissecting microscope to count the number of live and dead lice from each side of the scalp. They re-examined them up to 18 hours later to make sure all were dead. Nits were incubated for two weeks to see how many hatched.

“Effectiveness of the different treatment methods was assessed by comparing the percentage of dead lice and non-hatching eggs on the pre- and post-treatment sides of the scalp,” the researchers explain. The researchers measured the temperature and volume of hot air in each method and kept track of any discomfort.

Results: The Utah LouseBuster Massacre

No household cleaning measures were taken because they are not considered essential; head lice cannot survive more than 24 hours off a host’s head.

Each of the six treatment methods took 30 to 35 minutes and used air at about 140 degrees Fahrenheit. Here are the treatments, from least to most effective:

– Air hoses from two bonnet-style hair dryers fed air into one bonnet. This method killed only 10 percent of hatched lice but 89 percent of eggs.

– A handheld blow dryer was used to apply diffuse heating. Each child’s hair was divided into ten sections using hair clips, and the base of each section was heated three minutes while the dryer was moved to ensure even heating. This method killed only 21 percent of lice but 97 percent of eggs.

– A handheld blow dryer was used to apply directed heating. Hair clips were used to divide each child’s hair into 20 sections. The dryer was held still for 30 seconds to heat one side of each section, then held still another 30 seconds to heat the other side. This method killed 55 percent of lice and 98 percent of eggs.

– A hose was attached to a wall-mounted blow dryer like those in public restrooms. The dryer was put on a table, and the hose used to treat hair divided into 20 sections. The method’s larger air volume killed 62 percent of lice and 97 percent of eggs.

– With the hair divided into 14 to 20 sections, a LouseBuster without a hand piece was used to treat each section with diffuse heat for 60 seconds. Air speed was similar to the wall dryer. This technique killed 76 percent of lice and 94 percent of eggs.

– Aplastic hand piece with 10 coarse teeth (not like fine-toothed nit combs) was attached to the end of the LouseBuster hose and raked through hair while hot air blew the opposite direction. All areas of the scalp were raked and exposed to hot air for at least 30 seconds. The LouseBuster with the handpiece killed 80 percent of hatched lice – a larger proportion than any of the other five methods – and 98 percent of louse eggs.

The 80 percent kill rate was high enough to prevent remaining lice from breeding – possibly due to stress or sterilization – so “virtually all subjects were cured of head lice when examined one week following treatment with the LouseBuster,” the scientists write.

Children and their parents reported none of the treatments had adverse effects. Kids reported less discomfort from the LouseBuster than from any other method.

Clayton estimates it cost $500,000 to develop and test the LouseBuster, with funding from the Utah Centers of Excellence program, University of Utah, Primary Children’s Medical Center Foundation and the National Pediculosis Association.

A Lousy Problem

Each year, 6 million to 12 million Americans are infested with head lice, making children miss 12 million to 24 million school days, the researchers say.

“Although head lice do not produce an illness per se, they are physically and psychologically unpleasant for the child and an exasperating problem for parents and school authorities,” the scientists write.

Treatments have been chemical shampoos, louse combs and home remedies. Annual U.S. sales of anti-louse shampoos exceed $160 million, yet the shampoos are not very effective at killing nits, requiring repeat treatment. Many parents dislike using insecticide shampoos on children, and lice rapidly are evolving resistance to chemicals.

Louse combs are used to remove the eggs or nits, an effective procedure, but one that requires many hours over several days. “Most parents do not have the time or patience to comb out all the lice and eggs,” Clayton and colleagues write.

Some parents resort to home remedies such as bug spray, mayonnaise or kerosene. “These remedies can harm the child and there is little hard evidence that they are effective,” the researchers say.

Some of the scientists’ relatives got infested during the study. Clayton’s kids, Mimi and Roger, volunteered to be infested with lice and then were treated successfully.

“They like to shock their friends by telling them they served as guinea pigs in their dad’s research,” Clayton says. “I’m waiting for the authorities to show up. They haven’t yet.”

Another researcher had a relative participate involuntarily. In the study’s acknowledgements, Atkin says he “wishes to apologize to his wife (again) for accidentally giving her head lice.”

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The part of the brain responsible for making most decisions about how to behave seems to develop less quickly in children exposed to cocaine before they were born, University of Florida researchers have found.

Using a new form of magnetic resonance imaging, researchers compared 28 adolescents exposed to a mix of cocaine and other drugs in the womb with 25 children whose mothers did not use cocaine during pregnancy and pinpointed subtle differences in how the brain’s frontal lobe developed. Researchers noticed that pathways in the frontal lobe, which connect to other parts of the brain to send information, were not as well-defined in children exposed to cocaine before birth, according to findings published this month in the journal Pediatrics.

The children exposed to cocaine also fared slightly worse on tests designed to assess skills linked to the frontal lobe, such as when to act and when to stop, said Tamara D. Warner, Ph.D., a UF research assistant professor of pediatrics and the study’s lead author.

“We actually found that there is a relationship between the behavior and the brain,” Warner said. “There were significant associations with how well children were able to do certain tasks and how well-developed the connections in the brain were.”

Some of the children whose mothers did not use cocaine were exposed to alcohol, tobacco and marijuana, but they did not exhibit the same subtle differences in the brain.
Because the mothers of children exposed to cocaine used multiple drugs, how these drugs interacted was likely a big part of the problem, Warner said. The mothers had taken cocaine and varying combinations of alcohol, marijuana and tobacco, and the interactions among these drugs often are complicated, sometimes producing additional toxic substances, Warner added.

To get a better glimpse of the frontal lobe, researchers used a form of imaging that allowed them to see how water flows through pathways linked to other parts of the brain. How the water moved through these channels showed the researchers how developed these pathways were in each child’s brain. The pathways were more mature in children whose mothers did not use cocaine and not as well-formed in the children whose mothers had, the study showed.

The children, who ranged in age from 10 to 12 and were from similar socioeconomic backgrounds, also participated in two behavioral tests that Warner likened to “Simon Says” types of activities. On one test, children were asked to look at the word “red” but then name the color of the ink used to write the word. This showed how well they were able to ignore the instinct to read the written word and give the correct answer. On another test, which Warner likened to “connect the dots,” children were asked to connect a series of numbers in order on a page and then perform a similar exercise alternating between numbers and letters. The children in the drug-exposed group named fewer colors correctly and took longer to adapt to connecting both numbers and letters, Warner said.

Including observations about how the brain looks and behavioral test results in the study is important because it links an actual brain change in children to a behavior change, said Lynn T. Singer, a professor of pediatrics, psychology and general medical sciences at Case Western Reserve University who also studies prenatal cocaine exposure in children.

“This is one of the first findings that shows there is a difference in the way the brain works in (children exposed to cocaine),” Singer said. “It’s a very important study in that we’re getting new evidence of specific brain changes. The way the brain is wired is different for these children.”

Despite these subtle signs of damage, UF researchers say children exposed to cocaine before birth are still faring far better than people predicted in the 1980s, when they were dubbed “crack babies.” Past studies at UF and other institutions have shown that children exposed to cocaine before birth exhibit no more behavioral problems as toddlers than other children, have average IQ scores and face only slight problem-solving difficulties in school.

But the biggest questions won’t be answered until the children age, Warner said. Researchers do not know yet how these differences in the brain’s frontal lobe will affect children as they enter their teen years and are faced with peer pressure and tough decisions.

“Not knowing when to stop and when to inhibit your behavior could have much wider consequences than a Simon Says game,” Warner said. “The differences we found were intriguing, but they really are the first piece of the puzzle in understand how these children are developing.”

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