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Ibuprofen vs Expectant Management for hsPDA in Preterm Infants: Retrospective Cohort

NCT07533721 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 541

Last updated 2026-04-16

No results posted yet for this study

Summary

This retrospective cohort study compares ibuprofen treatment versus expectant management for hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. Data were collected from preterm infants with hsPDA admitted to the Department of Neonatology, Shengjing Hospital of China Medical University between June 2020 and June 2025. A total of 541 infants were included: 241 received ibuprofen and 300 received expectant management (no routine pharmacological closure, supportive care only). The primary outcome is PDA closure rate. Secondary outcomes include bronchopulmonary dysplasia (BPD), mortality, pulmonary hypertension, renal insufficiency, neonatal pneumonia, retinopathy of prematurity (ROP), intraventricular hemorrhage (IVH), pulmonary hemorrhage, and gastrointestinal bleeding. Analyses are stratified by gestational age (\<28 weeks, 28-33 weeks, 33-37 weeks) and adjusted for sex, multiple gestation, and maternal factors. The study aims to provide real-world evidence on the risks and benefits of ibuprofen closure in different gestational age subgroups.

Conditions

  • Patent Ductus Arteriosus
  • Infant, Premature

Interventions

DRUG

Ibuprofen

No routine pharmacological closure; fluid restriction, diuretics, or supportive care only.

Sponsors & Collaborators

  • Shengjing Hospital

    lead OTHER

Eligibility

Min Age
23 Weeks
Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07533721 on ClinicalTrials.gov