Characterization of Cleft Lip and Palate Conditions in Guatemala

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

Total Enrollment

629 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-30

Study Completion Date

2020-03-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cleft Lip Cleft Palate Cleft Lip and Palate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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CHOP (US)

Children with isolated cleft lip and/or cleft palate scheduled for surgery between 2012 to 2019 at the Children's Hospital of Philadelphia, Philadelphia, PA, USA.

No interventions assigned to this group

SFG (Guatemala)

Children with isolated cleft lip and/or cleft palate scheduled for surgery between 2017 and 2020 with Smiles for Guatemala, Guatemala City, Guatemala.

NA - survey instrument

Intervention Type OTHER

Survey instrument was administered verbally to parents of the Guatemalan cohort.

Interventions

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NA - survey instrument

Survey instrument was administered verbally to parents of the Guatemalan cohort.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes