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Completed

NCT Number: NCT04725370

Characterization of Cleft Lip and Palate Conditions in Guatemala

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.

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Key information

Conditions

Cleft Lip Cleft Lip and Palate Cleft Palate Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Jaw Abnormalities Jaw Diseases Lip Diseases Maxillofacial Abnormalities Mouth Abnormalities Mouth Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NA - survey instrument

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Surgical care

    Time frame: pre-surgery

    Type of surgery scheduled and patient age at time of scheduled surgery, data gathered by chart review

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2021
Registry last updated
Jan 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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