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Systematic Pediatric Care for Oral Clefts - South America

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00097149
Recruitment Status : Completed
First Posted : November 18, 2004
Last Update Posted : December 17, 2013
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE November 17, 2004
First Posted Date  ICMJE November 18, 2004
Last Update Posted Date December 17, 2013
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • SUBPROJECT A: Neonatal mortality
  • SUBPROJECT B: Neurodevelopmental outcome
  • Weight
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Systematic Pediatric Care for Oral Clefts - South America
Official Title  ICMJE Systematic Pediatric Care for Oral Clefts - South America
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cleft Lip
  • Cleft Palate
  • Congenital Defects
Intervention  ICMJE Procedure: Systematic pediatric care
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
696
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00097149
Other Study ID Numbers  ICMJE GN 04 Aim II
U01HD040561 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NICHD Global Network for Women's and Children's Health
Study Sponsor  ICMJE NICHD Global Network for Women's and Children's Health
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Jeff Murray, M.D. University of Iowa
PRS Account NICHD Global Network for Women's and Children's Health
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP