Characterization of Cleft Lip and Palate Conditions in Guatemala

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Cleft Palate; Cleft Lip; Cleft Lip and Palate

Treatments: Other: NA - survey instrument

Study type: Observational

Funder types: Other

Identifiers

NCT04725370

19-016144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 629 patients

Sex: All

Ages: Under 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

629 participants in 2 patient groups

CHOP (US)

Description:

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.

SFG (Guatemala)

Description:

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

Treatment:

Other: NA - survey instrument