Determinants of Digestive Morbidity in Neonatal Jaundice

March 11, 2026 updated by: The First Hospital of Jilin University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

3218

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Changchun
      • Jilin, Changchun, China, 130021
        • The First Hospital of Jilin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The study population is a retrospective cohort of neonates hospitalized in the Department of Neonatology at the First Hospital of Jilin University between December 2019 and December 2024. All included neonates were admitted within the first 7 days of life and were diagnosed with neonatal hyperbilirubinemia, defined as having a serum total bilirubin level exceeding the phototherapy threshold for their respective postnatal age and gestational age. This cohort will be analyzed to investigate the risk factors associated with the development of adverse digestive system outcomes.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adverse Digestive Outcome
Neonates with jaundice who developed adverse digestive system outcomes.
Other: Observation (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.
Non-Adverse Digestive Outcome
Neonates with jaundice who did not develop adverse digestive system outcomes.
Other: Observation (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From admission until hospital discharge or 28 days of life, whichever comes first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

January 1, 2026

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

March 11, 2026

First Posted (Actual)

March 16, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-MS-074

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data are derived from retrospective medical records. Data sharing is restricted by the hospital's data governance policies and Chinese regulations on personal information protection.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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