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Systematic Pediatric Care for Oral Clefts - South America

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
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
ClinicalTrials.gov Identifier:
NCT00097149
First received: November 17, 2004
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention
Cleft Lip
Cleft Palate
Congenital Defects
Procedure: Systematic pediatric care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Systematic Pediatric Care for Oral Clefts - South America

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • SUBPROJECT A: Neonatal mortality
  • SUBPROJECT B: Neurodevelopmental outcome
  • Weight

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 696
Study Start Date: May 2003
Study Completion Date: May 2006
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.

  Eligibility

Ages Eligible for Study:   up to 2 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097149

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
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:
No publications provided by NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00097149     History of Changes
Other Study ID Numbers: GN 04 Aim II, U01HD040561
Study First Received: November 17, 2004
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 25, 2014