Clinical Trials Directory

Trials / Completed

CompletedNCT07475624

Determinants of Digestive Morbidity in Neonatal Jaundice

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

Status
Completed
Phase
Study type
Observational
Enrollment
3,218 (actual)
Sponsor
The First Hospital of Jilin University · Academic / Other
Sex
All
Age
1 Day – 28 Days
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERObservation (Retrospective Cohort Study)This is an observational study. The "intervention" described here refers to the standard diagnostic and therapeutic measures already administered in routine clinical practice for neonatal jaundice. The study retrospectively observes the association between these routine practices (e.g., phototherapy, exchange transfusion, intravenous immunoglobulin administration) and the infants' digestive system outcomes. The research protocol did not actively assign or modify any treatments.

Timeline

Start date
2019-12-01
Primary completion
2024-12-01
Completion
2026-01-01
First posted
2026-03-16
Last updated
2026-03-16

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07475624. Inclusion in this directory is not an endorsement.