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
1 other identifier
observational
629
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2020
CompletedFirst Submitted
Initial submission to the registry
January 4, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2021
CompletedJanuary 26, 2021
January 1, 2021
2.4 years
January 4, 2021
January 25, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Cleft risk factors
during the surgery
Surgical care
pre-surgery
Study Arms (2)
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.
Interventions
Survey instrument was administered verbally to parents of the Guatemalan cohort.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oksana A Jackson, MD
Children's Hospital of Philadelphia
- PRINCIPAL INVESTIGATOR
Michelle Scott, DDS, MBA
Children's Hospital of Philadelphia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2021
First Posted
January 26, 2021
Study Start
October 30, 2017
Primary Completion
March 13, 2020
Study Completion
March 13, 2020
Last Updated
January 26, 2021
Record last verified: 2021-01