Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]

BACKGROUND: The contribution of birth defects, including cleft lip and palate, to neonatal and infant mortality and morbidity is substantial. As other mortality and morbidity causes including infections, hygiene, prematurity, and nutrition are eradicated in less developed countries, the burden of birth defects will increase proportionally. METHODS/DESIGN: We are using cleft lip and palate as a sentinel birth defect to evaluate its burden on neonatal and infant health and to assess the effectiveness of systematic pediatric care during the first month and first two years of life in decreasing this burden. The neonatal intervention, consisting of weekly pediatric evaluation and referral to appropriate care, is delivered to about 696 infants born with cleft lip and/or palate in 47 hospitals in South America. Neonatal mortality in this group will be compared to that in a retrospective control group of about 464 infants born with cleft lip and/or palate in the same hospitals. The subgroup of infants with isolated clefts of both the lip and palate (about 264) is also randomized into two groups, intervened and non-intervened, and further followed up over 2 years. Intervened cases are evaluated by pediatricians every three months and referred for appropriate care. The intervened and non-intervened cases will be compared over study outcomes to evaluate the intervention effectiveness. Non-intervened cases are matched and compared to healthy controls to assess the burden of cleft lip and palate. Outcomes include child's neurological and physical development and family social and economic conditions. DISCUSSION: Large-scale clinical trials to improve infant health in developing countries are commonly suggested, making it important to share the methods used in ongoing studies with other investigators implementing similar research. We describe here the content of our ongoing pediatric care study in South America. We hope that this may help researchers targeting this area to plan their studies more effectively and encourage the development of similar research efforts to target other birth defects or infant outcomes such as prematurity and low birth weight

Different Strokes for Different Folks? Contrasting Approaches to Cultural Adaptation of Parenting Interventions

Relevant achievements have been accomplished in prevention science with regard to disseminating efficacious parenting interventions among underserved populations. However, widespread disparities in availability of parenting services continue to negatively impact diverse populations in high-income countries (e.g., the USA) and low- and middle-income countries. As a result, a scholarly debate on cultural adaptation has evolved over the years. Specifically, some scholars have argued that in diverse cultural contexts, existing evidence-based parenting interventions should be delivered with strict fidelity to ensure effectiveness. Others have emphasized the need for cultural adaptations of interventions when disseminated among diverse populations. In this paper, we propose that discussions on cultural adaptation should be conceptualized as a “both-and,” rather than an “either-or” process. To justify this stance, we describe three distinct parenting intervention projects to illustrate how cultural adaptation and efficacy of evidence-based interventions can be achieved using contrasting approaches and frameworks, depending on cultural preferences and available resources of local contexts. Further, we suggest the need to develop guidelines for consistent reporting of cultural adaptation procedures as a critical component of future investigations. This discussion is relevant for the broader public health field and prevention science