Status:
COMPLETED
Systematic Pediatric Care for Oral Clefts - South America
Lead Sponsor:
NICHD Global Network for Women's and Children's Health
Collaborating Sponsors:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
Conditions:
Cleft Lip
Cleft Palate
Eligibility:
All Genders
Up to 2 years
Phase:
NA
Brief Summary
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/in...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
696 Patients enrolled
Trial Details
Trial ID
NCT00097149
Start Date
May 1 2003
End Date
May 1 2006
Last Update
December 17 2013
Active Locations (1)
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1
Latin-American Collaborative Study of Congenital Malformations (ECLAMC)
Rio de Janeiro, Brazil