Systematic Pediatric Care for Oral Clefts - South America

NCT00097149 | Completed DMC

• 2 other identifiers: GN 04 Aim IIU01HD040561
• Study Type: interventional
• Target: 696
• Locations: 1 country
• Sites: 1

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.

Conditions

Cleft Lip; Cleft Palate; Congenital Defects

Keywords

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

Outcome Measures

Primary Outcomes (3)

• SUBPROJECT A: Neonatal mortality

• SUBPROJECT B: Neurodevelopmental outcome

• Weight

Secondary Outcomes (2)

• 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

Interventions

Systematic pediatric care PROCEDURE

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NICHD Global Network for Women's and Children's Health: lead
• Global Network for Women's and Children's Health Research: collaborator
• Bill and Melinda Gates Foundation: collaborator
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator
• Fogarty International Center of the National Institute of Health: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Cancer Institute (NCI): collaborator
• RTI International: collaborator
• University of Iowa: collaborator
• Latin-American Collaborative Study of Congenital Malformations (ECLAMC): collaborator

Study Sites (1)

Latin-American Collaborative Study of Congenital Malformations (ECLAMC)

Rio de Janeiro, Brazil

Location

Related Publications (2)

• Wehby GL, Castilla EE, Goco N, Rittler M, Cosentino V, Javois L, Kindem M, Chakraborty H, Dutra G, Lopez-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.

  PMID: 22204448 DERIVED

• Wehby GL, Castilla EE, Goco N, Rittler M, Cosentino V, Javois L, McCarthy AM, Bobashev G, Litavecz S, Mariona A, Dutra G, Lopez-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. doi: 10.1186/1471-2431-6-9.

  PMID: 16563165 DERIVED

Related Links

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

MeSH Terms

Conditions

Cleft Lip; Cleft Palate; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities

Study Officials

• Jeff Murray, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2004
• First Posted: November 18, 2004
• Study Start: May 1, 2003
• Study Completion: May 1, 2006
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

BR (1)