Systematic Pediatric Care for Oral Clefts - South America

Cleft Palate Clinical Trial

Official title:

Systematic Pediatric Care for Oral Clefts - South America

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097149
• Other study ID #: GN 04 Aim II
• Secondary ID: U01HD040561
• Status: Completed
• Phase: N/A
• First received: November 17, 2004
• Last updated: December 16, 2013
• Start date: May 2003
• Est. completion date: May 2006

Study information

• Verified date: December 2013
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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/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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 696
• Est. completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Palate
• Congenital Abnormalities
• Congenital Defects

Intervention

Procedure:
• Systematic pediatric care

Locations

Country	Name	City	State
Brazil	Latin-American Collaborative Study of Congenital Malformations (ECLAMC)	Rio de Janeiro

Sponsors (10)

Lead Sponsor

Collaborator

NICHD Global Network for Women's and Children's Health

Bill and Melinda Gates Foundation, Global Network for Women's and Children's Health Research, John E. Fogarty International Center (FIC), Latin-American Collaborative Study of Congenital Malformations (ECLAMC), National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), RTI International, University of Iowa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUBPROJECT A: Neonatal mortality
Primary	SUBPROJECT B: Neurodevelopmental outcome
Primary	Weight
Secondary	SUBPROJECT A: Hospitalizations, Weight
Secondary	SUBPROJECT B: Height, Speech, Hearing, Mortality, Cleft surgery, Rate of weight gain, Financial burden, Syndromic classification, Emotional and social family development

External Links

•   Global Network for Women's and Children's Health Research
•   RTI International