Characterization of Cleft Lip and Palate Conditions in Guatemala

January 25, 2021 updated by: Children's Hospital of Philadelphia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

629

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children with 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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
Other: NA - survey instrument
Survey instrument was administered verbally to parents of the Guatemalan cohort.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cleft risk factors
Time Frame: 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
during the surgery
Surgical care
Time Frame: pre-surgery
Type of surgery scheduled and patient age at time of scheduled surgery, data gathered by chart review
pre-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Oksana A Jackson, MD, Children's Hospital of Philadelphia
  • Principal Investigator: Michelle Scott, DDS, MBA, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 30, 2017

Primary Completion (ACTUAL)

March 13, 2020

Study Completion (ACTUAL)

March 13, 2020

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (ACTUAL)

January 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-016144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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