Characterization of Cleft Lip and Palate Conditions in Guatemala

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04725370

Enrollment

629

Registered

2021-01-26

Start date

2017-10-30

Completion date

2020-03-13

Last updated

2021-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip, Cleft Lip and Palate, Cleft Palate

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 in their native language. Consent was also given orally in the caregivers native language. All data was de-identified prior to analysis.

Interventions

OTHERNA - survey instrument

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

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

0 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Cleft phenotype	pre-surgery	Presence, laterality, and completeness of cleft lip and/or palate as classified by the LAHSHAL system, data gathered by physical exam

Secondary

Measure	Time frame	Description
Cleft risk factors	during the surgery	Presence of potential risk factors for cleft lip and palate such as maternal exposures during pregnancy, data gathered by interview with caregivers
Surgical care	pre-surgery	Type of surgery scheduled and patient age at time of scheduled surgery, data gathered by chart review

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026