Systematic Pediatric Care for Oral Clefts - South America

Study Overview
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Brief Summary
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Cleft lip and palate are a significant component of morbid human birth defects in the developing world. This study measures the impact of having a child born with a cleft lip on subsequent maternal/infant family health, and whether frequent pediatric care compared to standard pediatric care will reduce neonatal mortality in children born with cleft lip and palate.

Detailed Description
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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.

Official Title
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Systematic Pediatric Care for Oral Clefts - South America

Conditions
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Cleft Lip, Cleft Palate, Congenital Defects

Intervention / Treatment
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* Procedure: Systematic pediatric care


Participation Criteria
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Eligibility Criteria
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Subproject A: All children born with an oral cleft in a participating hospital (hospitals in Argentina, Bolivia, Brazil, Chile, Colombia and Venezuela affiliated with ECLAMC) Subproject B: Cases from Subproject A that meet the following criteria: Cleft lip with or without cleft palate or cleft palate only Birth weight >2500 g No other identifiable birth defect: nonsyndromic Singleton (nonmultiple birth) No other complications requiring systematic care

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Systematic pediatric care|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUBPROJECT A: Neonatal mortality |  |  | 
| SUBPROJECT B: Neurodevelopmental outcome |  |  | 
| Weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUBPROJECT A: Hospitalizations, Weight |  |  | 
| SUBPROJECT B: Height, Speech, Hearing, Mortality, Cleft surgery, Rate of weight gain, Financial burden, Syndromic classification, Emotional and social family development |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congenital birth defects, Cleft lip, Cleft palate, Global Network, Neurodevelopmental outcome, Maternal and child health, International, Women's health, Brazil, Brasil, Latin America, ECLAMC, Argentina, Bolivia, Chile, Colombia, Ecuador, Venezuela