Status:

COMPLETED

Characterization of Cleft Lip and Palate Conditions in Guatemala

Lead Sponsor:

Children's Hospital of Philadelphia

Conditions:

Cleft Lip

Cleft Palate

Eligibility:

All Genders

Up to 18 years

Brief 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.

Detailed 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 i...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 30 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

March 13 2020

Estimated Enrollment :

629 Patients enrolled

Trial Details

Trial ID

NCT04725370

Start Date

October 30 2017

End Date

March 13 2020

Last Update

January 26 2021

Active Locations (1)

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1

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104