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临床试验/NCT07475624
NCT07475624已完成不适用

Analysis of Factors Associated With Adverse Digestive System Outcomes in Neonates With Jaundice

The First Hospital of Jilin University1 个研究点 分布在 1 个国家目标入组 3,218 人开始时间: 2019年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3,218
试验地点
1
主要终点
Adverse Digestive System Outcomes

研究概览

简要总结

Objective To explore the factors associated with adverse digestive system outcomes in neonates with jaundice.

Methods A retrospective analysis was conducted on clinical data of hospitalized neonates admitted to the Department of Neonatology, the First Hospital of Jilin University, within 7 days after birth from December 2019 to December 2024. Included neonates underwent serum total bilirubin testing, with post-birth serum total bilirubin levels exceeding the high-risk neonatal phototherapy threshold. Propensity score matching and inverse probability weighting were used to group the jaundiced neonates according to the presence or absence of adverse digestive system outcomes. Factors including basic demographic information of the neonates and their mothers, relevant laboratory examinations, and therapeutic interventions were collected. Traditional logistic regression and Cox proportional hazards models were applied to analyze and predict risk factors for adverse digestive system outcomes in jaundiced neonates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
1 Day 至 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates admitted to the Department of Neonatology within 7 days after birth.
  • Clinical diagnosis of neonatal jaundice, with a measured serum total bilirubin level exceeding the phototherapy threshold for hyperbilirubinemia.
  • Availability of complete medical records and serum bilirubin test results.
  • Hospitalized at the First Hospital of Jilin University between December 2019 and December 2024.

排除标准

  • Major congenital anomalies (e.g., severe gastrointestinal malformations, complex congenital heart disease).
  • Missing essential data for primary outcome or key exposure variables.
  • Length of hospital stay < 24 hours.

研究组 & 干预措施

Adverse Digestive Outcome

Neonates with jaundice who developed adverse digestive system outcomes.

干预措施: Observation (Retrospective Cohort Study) (Other)

Non-Adverse Digestive Outcome

Neonates with jaundice who did not develop adverse digestive system outcomes.

干预措施: Observation (Retrospective Cohort Study) (Other)

结局指标

主要结局

Adverse Digestive System Outcomes

时间窗: From admission until hospital discharge or 28 days of life, whichever comes first.

The presence of any clinically diagnosed adverse digestive outcome during hospitalization, including but not limited to feeding intolerance, necrotizing enterocolitis (NEC), cholestasis, or gastrointestinal bleeding.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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