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NCT04725370 Clinical Trial

Characterization of Cleft Lip and Palate Conditions in Guatemala

Cleft Lip and Palate Clinical Trial

Official title:
Comparison of Cleft Lip and Palate Between a United States Tertiary Care Center and a Guatemalan Surgical Mission: A Cohort Study of 629 Pediatric Patients and a Survey of Risk Factors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04725370
Other study ID # 19-016144
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 30, 2017
Est. completion date March 13, 2020

Study information
Verified date January 2021
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 629
Est. completion date March 13, 2020
Est. primary completion date March 13, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• NA - survey instrument
Survey instrument was administered verbally to parents of the Guatemalan cohort.

Locations
Country Name City State
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cleft phenotype Presence, laterality, and completeness of cleft lip and/or palate as classified by the LAHSHAL system, data gathered by physical exam pre-surgery
Secondary Cleft risk factors Presence of potential risk factors for cleft lip and palate such as maternal exposures during pregnancy, data gathered by interview with caregivers during the surgery
Secondary Surgical care Type of surgery scheduled and patient age at time of scheduled surgery, data gathered by chart review pre-surgery
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