NCT04725370已完成不适用
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
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 629
- 试验地点
- 1
- 主要终点
- Cleft phenotype
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cleft phenotype
时间窗: pre-surgery
Presence, laterality, and completeness of cleft lip and/or palate as classified by the LAHSHAL system, data gathered by physical exam
次要结局
- Surgical care(pre-surgery)
- Cleft risk factors(during the surgery)
研究者
研究点 (1)
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