Determinants of Digestive Morbidity in Neonatal Jaundice

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07475624

Enrollment

3218

Registered

2026-03-16

Start date

2019-12-01

Completion date

2026-01-01

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive

Keywords

neonates with jaundice ,adverse digestive outcomes,association

Brief 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.

Interventions

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Digestive System Outcomes	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026