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COMPLETEDNCT04725370

Characterization of Cleft Lip and Palate Conditions in Guatemala

The purpose of this study is to compare types of and risk factors for cleft lip and palate in a Guatemalan population to a United States population.

Lead sponsor: Children's Hospital of Philadelphia•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Children's Hospital of Philadelphia

Demographic, surgical, and cleft type data from US patients were gathered via chart review of the electronic medical record. Data from Guatemalan patients was gathered orally from patient caregivers in their native language. Consent was also given orally in the caregivers native language. All data was de-identified prior to analysis.

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•diagnosis of isolated cleft lip and/or palate
•scheduled for cleft-related surgery at either the Children's Hospital of Philadelphia or Smiles for Guatemala during the previously described time frames

Exclusion Criteria

•diagnosis of a recognized medical syndrome
•medically complex defined as having major medical problems in three or more organ systems
•diagnosis of isolated midline cleft lip
•diagnosis of Tessier facial cleft
•greater than 18 years of age

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 26, 2021Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment629

Start dateOct 2017

Last updatedJan 26, 2021

Condition

Cleft Lip Cleft Palate Cleft Lip and Palate

Locations shown

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 26, 2021Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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