Trial Information

Systematic Pediatric Care for Oral Clefts - South America

Craniofacial anomalies and cleft lip with or without cleft palate (CL/P) are a model for the
impact of birth defects on fetal and neonatal health directly and maternal health
indirectly. Craniofacial anomalies comprise a significant component of morbid human birth
defects. This study is composed of two Subprojects, A and B. Subproject A involves
provision of intensive pediatric care over the first 28 days of life for a prospective group
of about 694 cleft cases, which will be compared to a retrospective group of about 464 cleft
cases. Nonsyndromic cleft lip with or without cleft palate (NSCL/P) cases (about 264 cases)
of Subproject A will be randomized into two groups: intervened (about 132 cases) and
non-intervened (about 132 cases). Sub-project B involves provision of systematic pediatric
care over a 2-year period for the intervened group. This group will be compared to the
non-intervened group in order to study the effect of the intervention on the
neurodevelopment and physical health of the child as well as the emotional and social health
of the family. The standard care group also will be compared to a group of about 264
healthy controls, matched by sex and place and date of birth in order to study the impact of
the cleft on the physical health and neurodevelopment of the child as well as the emotional
and social health of the family. The importance of the study relates to the substantial
burden caused by clefts and the necessity of developing and testing approaches that may
lessen this burden. The outcomes of this project will be to further strengthen
collaborative relationships in the area of craniofacial anomalies between South America and
the United States; to better understand the effects of birth defects, and craniofacial
anomalies in particular, on maternal family units; and, to decrease the burden of these
defects directly. The sample size was based on an expected overall 28 days mortality rate
among cleft infants that is around 0.25, calculated at a 0.05 significance level.