Clinical trials in pediatrics

“Children are not little adults.” Almost all aspects of children's health including clinical trials and drug development are poor cousins of adult health. Over the years, pediatricians worldwide caution against blind extrapolation of adult data to children as it may result in considerable harm [1,2]. Also, it is increasingly recognized that the roots of many chronic diseases in adulthood stem from childhood and tackling health issues in children lead to improved health in adults [3,4]. Furthermore, investment in early childhood has long-term benefits in adults not only in health but also in other aspects of life such as education and crime reduction [4,5]. Arguably, health at birth is the single most important predictor of health in adulthood as the inequality of an infant at birth has intergenerational effects [5]. The Carolina Abecedarian Project showed that early childhood programs that are of high quality result in substantial societal benefits (e.g., reduction of crime, increased earnings, better education) [4,5]. A recent publication from this project found that this benefit also translated into improved adult health outcomes [4]. In a randomized trial, Campbell and colleagues described that disadvantaged children who were randomized to the intervention group (early education, health screenings and nutrition program) had significantly lower rates of metabolic syndrome, obesity and hypertension, when aged in their mid-30s, compared with the control group [4]...

Neonatal palliative care attitude scale : development of an instrument to measure the barriers to and facilitators of palliative care in neonatal nursing

OBJECTIVE The aim of this research project was to obtain an understanding of the barriers to and facilitators of providing palliative care in neonatal nursing. This article reports the first phase of this research: to develop and administer an instrument to measure the attitudes of neonatal nurses to palliative care. METHODS The instrument developed for this research (the Neonatal Palliative Care Attitude Scale) underwent face and content validity testing with an expert panel and was pilot tested to establish temporal stability. It was then administered to a population sample of 1285 neonatal nurses in Australian NICUs, with a response rate of 50% (N 645). Exploratory factor-analysis techniques were conducted to identify scales and subscales of the instrument. RESULTS Data-reduction techniques using principal components analysis were used. Using the criteria of eigenvalues being 1, the items in the Neonatal Palliative Care Attitude Scale extracted 6 factors, which accounted for 48.1% of the variance among the items. By further examining the questions within each factor and the Cronbach’s of items loading on each factor, factors were accepted or rejected. This resulted in acceptance of 3 factors indicating the barriers to and facilitators of palliative care practice. The constructs represented by these factors indicated barriers to and facilitators of palliative care practice relating to (1) the organization in which the nurse practices, (2) the available resources to support a palliative model of care, and (3) the technological imperatives and parental demands. CONCLUSIONS The subscales identified by this analysis identified items that measured both barriers to and facilitators of palliative care practice in neonatal nursing. While establishing preliminary reliability of the instrument by using exploratory factor-analysis techniques, further testing of this instrument with different samples of neonatal nurses is necessary using a confirmatory factor-analysis approach.

What works elsewhere? A review of physical activity intervention studies

Obesity and type 2 diabetes mellitus (T2D) have reached epidemic proportions in many parts of the world with numbers projected to rise dramatically in coming decades (Wang and Lobstein, 2006; Zaninotto et al., 2006). In Australia, and consistent with much of the developed world, the problem has been described as a ‘juggernaut’ that is out of control (Zimmet and James, 2007). Unfortunately the burgeoning problem of non-communicable diseases, including obesity and T2D, is also impacting developing nations as populations are undergoing a nutrition transition (Caballero, 2005). The increased prevalence of overweight and obesity in children, adolescents and adults in both the developed and developing world is consistent with reductions in all forms of physical activity (Brownson et al., 2005). This brief paper provides an overview of the importance of physical activity and an outline of physical activity intervention studies with particular reference to the growing years. As many interventions studies involving physical activity have been undertaken in the context of childhood obesity prevention (Lobstein et al., 2004), and an increasing proportion of the childhood population is overweight or obese, this is a major focus of discussion.

Ghrelin and obestatin concentrations during puberty: Relationships with adiposity, nutrition and physical activity

Ghrelin and obestatin are two peptides associated with appetite control and the regulation of energy balance in adults. It is intuitive that they have an important role in growth and development during puberty. Therefore, it is acknowledged that these peptides, in addition to others, form part of the substrate underlying energy homeostasis which in turn will contribute to body weight regulation and could explain changes in energy balance during puberty. Both peptides originate from the stomach; hence, it is intuitive that they are involved in generating signals from tissue stores which influence food intake. This could be manifested via alterations in the drive to eat (i.e. hunger), eating behaviors and appetite regulation. Furthermore, there is some evidence that these peptides might also be associated with physical activity behaviors and metabolism. Anecdotally, children and adolescents experience behavioral and metabolic changes during growth and development which will be associated with physiological changes.

Twelve-month effectiveness of a parent-led, family-focused weight-management program for prepubertal children : a randomized, controlled trial

BACKGROUND Parenting-skills training may be an effective age-appropriate child behavior-modification strategy to assist parents in addressing childhood overweight. OBJECTIVE Our goal was to evaluate the relative effectiveness of parenting-skills training as a key strategy for the treatment of overweight children. DESIGN The design consisted of an assessor-blinded, randomized, controlled trial involving 111 (64% female) overweight, prepubertal children 6 to 9 years of age randomly assigned to parenting-skills training plus intensive lifestyle education, parenting-skills training alone, or a 12-month wait-listed control. Height, BMI, and waist-circumference z score and metabolic profile were assessed at baseline, 6 months, and 12 months (intention to treat). RESULTS After 12 months, the BMI z score was reduced by ∼10% with parenting-skills training plus intensive lifestyle education versus ∼5% with parenting-skills training alone or wait-listing for intervention. Waist-circumference z score fell over 12 months in both intervention groups but not in the control group. There was a significant gender effect, with greater reduction in BMI and waist-circumference z scores in boys compared with girls. CONCLUSION Parenting-skills training combined with promoting a healthy family lifestyle may be an effective approach to weight management in prepubertal children, particularly boys. Future studies should be powered to allow gender subanalysis.

Determinants of rapid weight gain during infancy: Baseline results from the NOURISH randomised controlled trial.

Background: Rapid weight gain in infancy is an important predictor of obesity in later childhood. Our aim was to determine which modifiable variables are associated with rapid weight gain in early life. Methods: Subjects were healthy infants enrolled in NOURISH, a randomised, controlled trial evaluating an intervention to promote positive early feeding practices. This analysis used the birth and baseline data for NOURISH. Birthweight was collected from hospital records and infants were also weighed at baseline assessment when they were aged 4-7 months and before randomisation. Infant feeding practices and demographic variables were collected from the mother using a self administered questionnaire. Rapid weight gain was defined as an increase in weight-for-age Z-score (using WHO standards) above 0.67 SD from birth to baseline assessment, which is interpreted clinically as crossing centile lines on a growth chart. Variables associated with rapid weight gain were evaluated using a multivariable logistic regression model. Results: Complete data were available for 612 infants (88% of the total sample recruited) with a mean (SD) age of 4.3 (1.0) months at baseline assessment. After adjusting for mother's age, smoking in pregnancy, BMI, and education and infant birthweight, age, gender and introduction of solid foods, the only two modifiable factors associated with rapid weight gain to attain statistical significance were formula feeding [OR=1.72 (95%CI 1.01-2.94), P= 0.047] and feeding on schedule [OR=2.29 (95%CI 1.14-4.61), P=0.020]. Male gender and lower birthweight were non-modifiable factors associated with rapid weight gain. Conclusions: This analysis supports the contention that there is an association between formula feeding, feeding to schedule and weight gain in the first months of life. Mechanisms may include the actual content of formula milk (e.g. higher protein intake) or differences in feeding styles, such as feeding to schedule, which increase the risk of overfeeding. Trial Registration: Australian Clinical Trials Registry ACTRN12608000056392

Predictors of and reasons for pacifier use in first-time mothers : an observational study

Background: The use of pacifiers is commonplace in Australia and has been shown to be negatively associated with breastfeeding duration. In order to influence behaviour related to the use of pacifiers it is important to understand the reasons for their use. The primary aim of this observational study was to investigate who (if anyone) advises first-time mothers to give a pacifier and the reasons for which they first give (or try to give) a pacifier to their infant. Additionally, this study investigated the predictors of pacifier use and the relationship between pacifier use and breastfeeding duration. Methods: In total, 670 Australian first-time mothers recruited as part of the NOURISH trial completed a questionnaire regarding infant feeding and pacifier use. Results: Pacifiers were introduced by 79% of mothers, of whom 28.7% were advised to use a pacifier by their mother/mother-in-law with a further 22.7% being advised by a midwife. The majority of mothers used a pacifier in order to soothe their infant (78.3%), to help put them to sleep (57.4%) and to keep them comforted and quiet (40.4%). Pacifiers given to infants before four weeks (adjHR 3.67; 95%CI 2.14–6.28) and used most days (adjHR 3.28; 95%CI 1.92–5.61) were significantly associated with shorter duration of breastfeeding. Conclusions: This study identifies an opportunity for educating new mothers and their support network, particularly their infant’s grandmothers, with regards to potential risks associated with the early and frequent use of a pacifier, and alternative methods for soothing their infant, in order to reduce the use of pacifiers and their potentially negative effect on breastfeeding duration

Practical physical activity measurement in youth : a review of contemporary approaches

Background: The accurate evaluation of physical activity levels amongst youth is critical for quantifying physical activity behaviors and evaluating the effect of physical activity interventions. The purpose of this review is to evaluate contemporary approaches to physical activity evaluation amongst youth. Data sources: The literature from a range of sources was reviewed and synthesized to provide an overview of contemporary approaches for measuring youth physical activity. Results: Five broad categories are described: self-report, instrumental movement detection, biological approaches, direct observation, and combined methods. Emerging technologies and priorities for future research are also identified. Conclusions: There will always be a trade-off between accuracy and available resources when choosing the best approach for measuring physical activity amongst youth. Unfortunately, cost and logistical challenges may prohibit the use of "gold standard" physical activity measurement approaches such as doubly labelled water. Other objective methods such as heart rate monitoring, accelerometry, pedometry, indirect calorimetry, or a combination of measures have the potential to better capture the duration and intensity of physical activity, while self-reported measures are useful for capturing the type and context of activity.

A parent-led family-focused treatment program for overweight children aged 5 to 9 years : The PEACH RCT

OBJECTIVE: To evaluate a healthy lifestyle intervention to reduce adiposity in children aged 5 to 9 years and assess whether adding parenting skills training would enhance this effect. PARTICIPANTS AND METHODS: We conducted a single-blinded randomized controlled trial of prepubertal moderately obese (International Obesity Task Force cut points) children, aged 5 to 9 years. The 6-month program targeted parents as the agents of change for implementing family lifestyle changes. Only parents attended group sessions. We measured BMI and waist z scores and parenting constructs at baseline, 6, 12, 18, 24 months. RESULTS: Participants (n = 169; 56% girls) were randomized to a parenting skills plus healthy lifestyle group (n = 85) or a healthy lifestyle–only group (n = 84). At final 24-month assessment 52 and 54 children remained in the parenting skills plus healthy lifestyle and the healthy lifestyle–only groups respectively. There were reductions (P < .001) in BMI z score (0.26 [95% confidence interval: 0.22–0.30]) and waist z score (0.33 [95% confidence interval: 0.26–0.40]). There was a 10% reduction in z scores from baseline to 6 months that was maintained to 24 months with no additional intervention. Overall, there was no significant group effect. A similar pattern of initial improvement followed by stability was observed for parenting outcomes and no group effect. CONCLUSIONS: Using approaches that specifically target parent behavior, relative weight loss of ∼10% is achievable in moderately obese prepubertal children and can be maintained for 2 years from baseline. These results justify an investment in treatment as an effective secondary obesity-prevention strategy.

Baby-friendly hospital accreditation, in-hospital care practices and breastfeeding : a population based survey

OBJECTIVES: To investigate the effect of Baby-Friendly Hospital Initiative (BFHI) accreditation and hospital care practices on breastfeeding rates at 1 and 4 months. METHODS: All women who birthed in Queensland, Australia, from February 1 to May 31, 2010, received a survey 4 months postpartum. Maternal, infant, and hospital characteristics; pregnancy and birth complications; and infant feeding outcomes were measured. RESULTS: Sample size was 6752 women. Breastfeeding initiation rates were high (96%) and similar in BFHI-accredited and nonaccredited hospitals. After adjustment for significant maternal, infant, clinical, and hospital variables, women who birthed in BFHI-accredited hospitals had significantly lower odds of breastfeeding at 1 month (adjusted odds ratio 0.72, 95% confidence interval 0.58–0.90) than those who birthed in non–BFHI-accredited hospitals. BFHI accreditation did not affect the odds of breastfeeding at 4 months or exclusive breastfeeding at 1 or 4 months. Four in-hospital practices (early skin-to-skin contact, attempted breastfeeding within the first hour, rooming-in, and no in-hospital supplementation) were experienced by 70% to 80% of mothers, with 50.3% experiencing all 4. Women who experienced all 4 hospital practices had higher odds of breastfeeding at 1 month (adjusted odds ratio 2.20, 95% confidence interval 1.78–2.71) and 4 months (adjusted odds ratio 2.93, 95% confidence interval 2.40–3.60) than women who experienced fewer than 4. CONCLUSIONS: When breastfeeding-initiation rates are high and evidence-based practices that support breastfeeding are common within the hospital environment, BFHI accreditation per se has little effect on both exclusive or any breastfeeding rates.C

Australian adolescents’ perceived school-based barriers and facilitators to engagement in physical activity

OBJECTIVE: School-aged youth spend a significant amount of time either in transit to and from school, or within school settings performing a range of varying learning-based activities. Adolescent physical activity has also been shown to increase the likelihood of maintaining physical activity throughout adulthood. The purpose of this study is to investigate adolescents’ perceived school-based barriers and facilitators to engagement in physical activity. METHODS: One-hundred and twenty four participants (38 males and 86 females) were recruited from two non-denominational same-sex private schools, in Brisbane, Australia. The mean age and standard deviation (SD) was 13.83 (0.56) and 14.40 (2.33) for males and females respectively. Participants responded to a series questions regarding perceived barriers and facilitators to engagement in physical activity. Quantitative data was analysed using descriptive statistics and frequency distributions, and qualitative data with thematic analysis. RESULTS: A total of 121 (97.6%) participants had complete data sets and were included in the analysis. School timetable (44.6%), homework (81.8%), and assessment (81.0%) were identified as the most prominent perceived factors, increasing the difficulty of physical activity engagement. Physical Education classes (71.9%) and school sport programs (80.2%) were identified as the most prominent perceived factors that facilitate engagement in physical activity. There was no significant gender effect. CONCLUSIONS: Each of the identified factors perceived by adolescent's as either barriers or facilitators to engagement in physical activity may be addressed by administrators at a school and government policy level. These may include strategies such as; increasing the assigned hours to physical education classes, providing additional extra-curricular sporting opportunities, and reviewing the time allocated to homework and assessment items. This may provide a simpler, low-cost solution to increasing youth physical activity, as opposed to contemporary higher-cost strategies utilising increased staff commitment, mass media, provision of equipment and counsellors and other health professionals.

The use of SMS messaging for physical activity promotion : preferences of Australian adolescents and their parents

OBJECTIVE: Recent increases in youth mobile phone ownership and usage may provide a unique and innovative opportunity for engagement by health promoters, via a familiar and immediately accessible medium. This study investigated adolescents’ and their parents’ preferences for promoting physical activity via means of SMS messaging. METHODS: Adolescents (36 males and 76 females) and their parents (37 males 75 females) were recruited from two non-denominational same-sex private schools, in Brisbane, Australia. The mean age and standard deviation (SD) for adolescents and parents was 14.03 (0.58) and 47.18 (4.65) respectively. Participants responded to a series of questions regarding mobile phone ownership, and preferences for physical activity, school-based physical activity programs, and programs invovling SMS messaging. Data analysis included descriptive statistics and frequency distributions. T-tests were employed to measure gender effect. RESULTS: Overall, 47 (42%) parents desired their child to be more physically active, and were interested for their child to participate in a school-based physical activity program. Of those parents, 16 (34%) parents were interested in their child participating in an SMS-based physical activity program, with 21 (45%) not interested, and 10 (21%) neutral. One hundred and four (95%) adolescents owned a mobile phone, with 84 (82%) of those adolescents wanting to be more physically active. Of those adolescents, 14 (17%) were interested in participating in an SMS-based physical activity program, with 40 (48%) not interested, and 30 (36%) neutral. There was no significant gender effect. CONCLUSIONS: Although SMS messaging may provide an innovative method for youth physical activity promotion, low levels of interest are concerning. These results differ from other studies utilising SMS messaging for the purpose of health promotion, where more positive feedback from participants were reported. A screening process to gauge interest prior to the implementation of any SMS-based health promotion program may prove invaluable toward the success of the program.