Systematic Pediatric Care for Oral Clefts - South America

• ClinicalTrials.gov Identifier: NCT00097149
• Recruitment Status: Completed
• First Posted: November 18, 2004
• Last Update Posted: December 17, 2013
• Sponsor: NICHD Global Network for Women's and Children's Health
• Collaborators: Global Network for Women's and Children's Health Research; Bill and Melinda Gates Foundation; National Institute of Dental and Craniofacial Research (NIDCR); Fogarty International Center of the National Institute of Health; National Center for Complementary and Integrative Health (NCCIH); National Cancer Institute (NCI); RTI International; University of Iowa; Latin-American Collaborative Study of Congenital Malformations (ECLAMC)
• Information provided by (Responsible Party): NICHD Global Network for Women's and Children's Health

Study Description

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/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.

Condition or disease	Intervention/treatment	Phase
Cleft Lip; Cleft Palate; Congenital Defects	Procedure: Systematic pediatric care	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 696 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Systematic Pediatric Care for Oral Clefts - South America
• Study Start Date: May 2003
• Actual Study Completion Date: May 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. SUBPROJECT A: Neonatal mortality
2. SUBPROJECT B: Neurodevelopmental outcome
3. Weight

Secondary Outcome Measures :

1. SUBPROJECT A: Hospitalizations, Weight
2. SUBPROJECT B: Height, Speech, Hearing, Mortality, Cleft surgery, Rate of weight gain, Financial burden, Syndromic classification, Emotional and social family development

Eligibility Criteria

• Ages Eligible for Study: up to 2 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Brazil

Latin-American Collaborative Study of Congenital Malformations (ECLAMC)

Rio de Janeiro, Brazil

Sponsors and Collaborators

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

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

Bill and Melinda Gates Foundation

National Institute of Dental and Craniofacial Research (NIDCR)

Fogarty International Center of the National Institute of Health

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

RTI International

University of Iowa

Latin-American Collaborative Study of Congenital Malformations (ECLAMC)

Investigators

• Principal Investigator: Jeff Murray, M.D.; University of Iowa

More Information

Additional Information:

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

RTI International 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wehby GL, Castilla EE, Goco N, Rittler M, Cosentino V, Javois L, Kindem M, Chakraborty H, Dutra G, López-Camelo JS, Orioli IM, Murray JC. The effect of systematic pediatric care on neonatal mortality and hospitalizations of infants born with oral clefts. BMC Pediatr. 2011 Dec 28;11:121. doi: 10.1186/1471-2431-11-121.

Wehby GL, Castilla EE, Goco N, Rittler M, Cosentino V, Javois L, McCarthy AM, Bobashev G, Litavecz S, Mariona A, Dutra G, López-Camelo JS, Orioli IM, Murray JC. Description of the methodology used in an ongoing pediatric care interventional study of children born with cleft lip and palate in South America [NCT00097149]. BMC Pediatr. 2006 Mar 24;6:9.

• Responsible Party: NICHD Global Network for Women's and Children's Health
• ClinicalTrials.gov Identifier: NCT00097149
• Other Study ID Numbers: GN 04 Aim II; U01HD040561 ( U.S. NIH Grant/Contract )
• First Posted: November 18, 2004
• Last Update Posted: December 17, 2013
• Last Verified: December 2013

Keywords provided by NICHD Global Network for Women's and Children's Health:

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

Additional relevant MeSH terms:

Cleft Palate; Cleft Lip; Congenital Abnormalities; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities