Patent Ductus ArteriosusIMPACT-PDANCT07533721
Ibuprofen vs Expectant Management for hsPDA in Preterm Infants: Retrospective Cohort
An observational study of Patent Ductus Arteriosus and Infant, Premature, run by Shengjing Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 37 weeks
- Conditions the study is for
- Patent Ductus Arteriosus, Infant, Premature
- What is being tested?
- Ibuprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 541 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 37 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
China1 site
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
About this study
Official title: Individualized Management Over Routine Intervention: Evidence Against Early Ibuprofen for PDA From Combined Retrospective and Meta-Analytic Data
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.
Read the detailed description
Background: Patent ductus arteriosus (PDA) is common in preterm infants. When hemodynamically significant (hsPDA), it may lead to pulmonary overcirculation, systemic hypoperfusion, and increased risk of bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), and other neonatal morbidities. Pharmacological closure with cyclooxygenase inhibitors such as ibuprofen is often used, but the benefits of routine closure remain controversial, particularly across different gestational age groups. Expectant management (allowing spontaneous closure without drugs) has gained interest, but comparative data are limited.
Objectives:
To compare ibuprofen versus expectant management for PDA closure and neonatal outcomes in preterm infants with hsPDA.
To examine effect modification by gestational age (<28 weeks, 28-33 weeks, 33-37 weeks).
To explore associations with sex, multiple gestation, and maternal factors. Study design: Single-center retrospective cohort study.
Setting: Department of Neonatology, Shengjing Hospital of China Medical University, Shenyang, China.
Participants: Preterm infants with echocardiographically confirmed hsPDA born between June 2020 and June 2025. Exclusion criteria: major congenital anomalies, chromosomal disorders, congenital heart disease other than PDA, contraindications to ibuprofen (e.g., renal failure, necrotizing enterocolitis), missing outcome data, or prior receipt of other PDA pharmacotherapy.
Intervention: Ibuprofen (oral or intravenous) at standard neonatal dosing (typically 10-5-5 mg/kg). Timing and duration as per clinical protocol.
Comparator: Expectant management - no routine pharmacological closure, allowing fluid restriction, diuretics, or supportive care alone.
Outcomes:
Primary: PDA closure (confirmed by echocardiography).
Secondary: BPD, mortality (all causes), pulmonary hypertension, renal insufficiency, neonatal pneumonia, ROP (any stage), IVH (any grade), pulmonary hemorrhage, gastrointestinal bleeding.
Data sources: Electronic medical records of Shengjing Hospital.
Statistical analysis:Descriptive statistics: frequencies, means (SD) or medians (IQR).
Bivariate comparisons: chi-square or Fisher's exact test for categorical variables; t-test or Mann-Whitney U test for continuous variables.
Multivariable logistic regression to estimate adjusted risk ratios (RR) and 95% confidence intervals for outcomes, adjusting for gestational age, sex, multiple gestation, and maternal factors (e.g., preeclampsia, chorioamnionitis).
Stratified analyses by gestational age subgroups.
Sensitivity analyses: excluding infants with protocol deviations or incomplete follow-up.
Ethical approval: Obtained from the Clinical Research Ethics Committee of Shengjing Hospital of China Medical University (approval number to be inserted). The study adheres to the Declaration of Helsinki.
Limitations: Single-center design, potential selection bias, residual confounding despite multivariable adjustment. Results may not be generalizable to other settings.
Dissemination: Results will be submitted for publication in a peer-reviewed journal.
- Conditions
- Patent Ductus Arteriosus, Infant, Premature
- Being tested
- Ibuprofen
- Keywords
- ibuprofen, expectant management, preterm infants, retrospective cohort, PDA, bronchopulmonary dysplasia
- Medical subject headings
- Ductus Arteriosus, Patent, Premature Birth, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
No routine pharmacological closure; fluid restriction, diuretics, or supportive care only.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen Group | Preterm infants with hsPDA who received ibuprofen (oral or intravenous) at standard neonatal dosing. n=241. Receives: Drug: Ibuprofen | |
| Expectant Management Group | Preterm infants with hsPDA who received no routine pharmacological closure, only fluid restriction, diuretics, or supportive care. n=300. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with PDA Closure
Proportion of preterm infants with echocardiographically confirmed closure of hemodynamically significant patent ductus arteriosus (hsPDA).
Measured: At day 7 after intervention start (or equivalent time point for expectant management group)
Secondary outcomes (9)
Number of Participants with Bronchopulmonary Dysplasia (BPD)
Description: BPD defined as need for supplemental oxygen or respiratory support at 36 weeks postmenstrual age.
Measured: At 36 weeks postmenstrual age (measured between 35+0 and 36+6 weeks)
Number of Participants who Died (All-cause Mortality)
Death from any cause during the neonatal period.
Measured: From birth to hospital discharge, up to 28 days
Number of Participants with Pulmonary Hypertension
Echocardiographic evidence of elevated pulmonary artery pressure.
Measured: During initial hospitalization, up to 12 weeks
Number of Participants with Renal Insufficiency
Serum creatinine >1.5 mg/dL or oliguria (<1 mL/kg/h for 24 hours).
Measured: Within first 7 days after intervention start
Number of Participants with Neonatal Pneumonia
Clinical and radiographic diagnosis of pneumonia
Measured: During initial hospitalization, up to 12 weeks
Number of Participants with Retinopathy of Prematurity (ROP)
Any stage of ROP as diagnosed by ophthalmologic examination.
Measured: Prior to discharge or at 40 weeks postmenstrual age, up to 16 weeks
Number of Participants with Intraventricular Hemorrhage (IVH)
Any grade of IVH diagnosed by cranial ultrasound.
Measured: Within first 14 days of life
Number of Participants with Pulmonary Hemorrhage
Sudden deterioration with bloody tracheal aspirate confirmed by chest radiograph.
Measured: During initial hospitalization, up to 12 weeks
Number of Participants with Gastrointestinal Bleeding
Melena, hematemesis, or bloody gastric aspirate requiring intervention.
Measured: Within first 7 days after intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jun 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 541 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyang Ma, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533721
- Sponsor's protocol ID
- SJ-HSPDA-2020-2025
- Other IDs
- 82101813, 2024-MSLH-569, M0428
- Acronym
- IMPACT-PDA
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and privacy restrictions. The study uses de-identified electronic medical records from a single hospital, and patient consent for data sharing was not obtained. Access to the data is governed by the hospital's ethics committee and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Management Over Routine Intervention: Evidence Against Early Ibuprofen for PDA From Combined Retrospective and Meta-Analytic Data
- ClinicalTrials.gov ID
- NCT07533721
- Acronym / sponsor ID
- IMPACT-PDA / SJ-HSPDA-2020-2025
- Conditions
- Patent Ductus Arteriosus, Infant, Premature
- Keywords
- ibuprofen, expectant management, preterm infants, retrospective cohort, PDA, bronchopulmonary dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 541 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Patent ductus arteriosus (PDA) is common in preterm infants. When hemodynamically significant (hsPDA), it may lead to pulmonary overcirculation, systemic hypoperfusion, and increased risk of bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), and other neonatal morbidities. Pharmacological closure with cyclooxygenase inhibitors such as ibuprofen is often used, but the benefits of routine closure remain controversial, particularly across different gestational age groups. Expectant management (allowing spontaneous closure without drugs) has gained interest, but comparative data are limited.
Objectives:
To compare ibuprofen versus expectant management for PDA closure and neonatal outcomes in preterm infants with hsPDA.
To examine effect modification by gestational age (<28 weeks, 28-33 weeks, 33-37 weeks).
To explore associations with sex, multiple gestation, and maternal factors. Study design: Single-center retrospective cohort study.
Setting: Department of Neonatology, Shengjing Hospital of China Medical University, Shenyang, China.
Participants: Preterm infants with echocardiographically confirmed hsPDA born between June 2020 and June 2025. Exclusion criteria: major congenital anomalies, chromosomal disorders, congenital heart disease other than PDA, contraindications to ibuprofen (e.g., renal failure, necrotizing enterocolitis), missing outcome data, or prior receipt of other PDA pharmacotherapy.
Intervention: Ibuprofen (oral or intravenous) at standard neonatal dosing (typically 10-5-5 mg/kg). Timing and duration as per clinical protocol.
Comparator: Expectant management - no routine pharmacological closure, allowing fluid restriction, diuretics, or supportive care alone.
Outcomes:
Primary: PDA closure (confirmed by echocardiography).
Secondary: BPD, mortality (all causes), pulmonary hypertension, renal insufficiency, neonatal pneumonia, ROP (any stage), IVH (any grade), pulmonary hemorrhage, gastrointestinal bleeding.
Data sources: Electronic medical records of Shengjing Hospital.
Statistical analysis:Descriptive statistics: frequencies, means (SD) or medians (IQR).
Bivariate comparisons: chi-square or Fisher's exact test for categorical variables; t-test or Mann-Whitney U test for continuous variables.
Multivariable logistic regression to estimate adjusted risk ratios (RR) and 95% confidence intervals for outcomes, adjusting for gestational age, sex, multiple gestation, and maternal factors (e.g., preeclampsia, chorioamnionitis).
Stratified analyses by gestational age subgroups.
Sensitivity analyses: excluding infants with protocol deviations or incomplete follow-up.
Ethical approval: Obtained from the Clinical Research Ethics Committee of Shengjing Hospital of China Medical University (approval number to be inserted). The study adheres to the Declaration of Helsinki.
Limitations: Single-center design, potential selection bias, residual confounding despite multivariable adjustment. Results may not be generalizable to other settings.
Dissemination: Results will be submitted for publication in a peer-reviewed journal.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen Group | – | Drug: IbuprofenPreterm infants with hsPDA who received ibuprofen (oral or intravenous) at standard neonatal dosing. n=241. |
| Expectant Management Group | – | –Preterm infants with hsPDA who received no routine pharmacological closure, only fluid restriction, diuretics, or supportive care. n=300. |
Who may qualify
- Ages
- 23 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- - 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenNo routine pharmacological closure; fluid restriction, diuretics, or supportive care only. | Drug | Ibuprofen Group |
Primary outcome
Number of Participants with PDA Closure
Time frame: At day 7 after intervention start (or equivalent time point for expectant management group)
Proportion of preterm infants with echocardiographically confirmed closure of hemodynamically significant patent ductus arteriosus (hsPDA).
9 secondary outcomes
Number of Participants with Bronchopulmonary Dysplasia (BPD)
Time frame: At 36 weeks postmenstrual age (measured between 35+0 and 36+6 weeks)
Number of Participants who Died (All-cause Mortality)
Time frame: From birth to hospital discharge, up to 28 days
Number of Participants with Pulmonary Hypertension
Time frame: During initial hospitalization, up to 12 weeks
Number of Participants with Renal Insufficiency
Time frame: Within first 7 days after intervention start
Number of Participants with Neonatal Pneumonia
Time frame: During initial hospitalization, up to 12 weeks
Number of Participants with Retinopathy of Prematurity (ROP)
Time frame: Prior to discharge or at 40 weeks postmenstrual age, up to 16 weeks
Number of Participants with Intraventricular Hemorrhage (IVH)
Time frame: Within first 14 days of life
Number of Participants with Pulmonary Hemorrhage
Time frame: During initial hospitalization, up to 12 weeks
Number of Participants with Gastrointestinal Bleeding
Time frame: Within first 7 days after intervention start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and privacy restrictions. The study uses de-identified electronic medical records from a single hospital, and patient consent for data sharing was not obtained. Access to the data is governed by the hospital's ethics committee and institutional policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus and Infant, Premature, run by Shengjing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with PDA Closure (time frame: At day 7 after intervention start (or equivalent time point for expectant management group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.