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

NCT07533721 | Completed

• 4 other identifiers: SJ-HSPDA-2020-2025821018132024-MSLH-569M0428
• Study Type: observational
• Target: 541
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ibuprofen; expectant management; preterm infants; retrospective cohort; PDA; bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• Number of Participants with PDA Closure

  Proportion of preterm infants with echocardiographically confirmed closure of hemodynamically significant patent ductus arteriosus (hsPDA).

  At day 7 after intervention start (or equivalent time point for expectant management group)

Secondary Outcomes (9)

• Number of Participants with Bronchopulmonary Dysplasia (BPD)

  At 36 weeks postmenstrual age (measured between 35+0 and 36+6 weeks)

• Number of Participants who Died (All-cause Mortality)

  From birth to hospital discharge, up to 28 days

• Number of Participants with Pulmonary Hypertension

  During initial hospitalization, up to 12 weeks

• Number of Participants with Renal Insufficiency

  Within first 7 days after intervention start

• Number of Participants with Neonatal Pneumonia

  During initial hospitalization, up to 12 weeks

Study Arms (2)

Ibuprofen Group

Preterm infants with hsPDA who received ibuprofen (oral or intravenous) at standard neonatal dosing. n=241.

Drug: Ibuprofen

Expectant Management Group

Preterm infants with hsPDA who received no routine pharmacological closure, only fluid restriction, diuretics, or supportive care. n=300.

Interventions

Ibuprofen DRUG

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

Ibuprofen Group

Eligibility Criteria

• Age: 23 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants with hsPDA treated at a tertiary NICU in China. The cohort includes 541 infants: 241 received ibuprofen, 300 received expectant management. Gestational age subgroups: \<28 weeks, 28-33 weeks, 33-37 weeks. Both sexes included. No healthy volunteers.

You may qualify if:

• \- Preterm infants (gestational age \<37 weeks) with echocardiographically confirmed hemodynamically significant patent ductus arteriosus (hsPDA)
• Admitted to the Department of Neonatology, Shengjing Hospital of China Medical University between June 2020 and June 2025

You may not qualify if:

• \- Major congenital anomalies or chromosomal disorders
• Congenital heart disease other than PDA
• Contraindications to ibuprofen (e.g., renal failure, necrotizing enterocolitis)
• Missing outcome data
• Received other PDA pharmacotherapy before study intervention

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth; Bronchopulmonary Dysplasia

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neonatology

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 16, 2026
• Study Start: June 1, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)