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Completed

NCT Number: NCT07475624

Determinants of Digestive Morbidity in Neonatal Jaundice

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.

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Key information

Conditions

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Hospital of Jilin University

Jilin City, Changchun, 130021, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Observation (Retrospective Cohort Study)

Other

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.

Primary outcomes

  1. Adverse Digestive System Outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

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.