Systematic Pediatric Care for Oral Clefts - South America
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cleft Lip Cleft Palate Congenital Defects | Procedure: Systematic pediatric care | Not Applicable |
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 |

- SUBPROJECT A: Neonatal mortality
- SUBPROJECT B: Neurodevelopmental outcome
- Weight
- 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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097149
Brazil | |
Latin-American Collaborative Study of Congenital Malformations (ECLAMC) | |
Rio de Janeiro, Brazil |
Principal Investigator: | Jeff Murray, M.D. | University of Iowa |
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 |
Other Study ID Numbers: |
GN 04 Aim II U01HD040561 ( U.S. NIH Grant/Contract ) |
First Posted: | November 18, 2004 Key Record Dates |
Last Update Posted: | December 17, 2013 |
Last Verified: | December 2013 |
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 |
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 |