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Systematic Pediatric Care for Oral Clefts - South America

NCT ID: NCT00097149

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

696 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Cleft Lip Cleft Palate Congenital Defects

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Systematic pediatric care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role collaborator

Latin-American Collaborative Study of Congenital Malformations (ECLAMC)

OTHER

Sponsor Role collaborator

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

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeff Murray, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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Latin-American Collaborative Study of Congenital Malformations (ECLAMC)

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 22204448 (View on PubMed)

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.

Reference Type DERIVED
PMID: 16563165 (View on PubMed)

Related Links

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http://gn.rti.org

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

http://www.rti.org/

RTI International

Other Identifiers

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U01HD040561

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GN 04 Aim II

Identifier Type: -

Identifier Source: org_study_id