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Trial · NCT03860428

Early Treatment Versus Expectant Management of PDA in Preterm Infants

NCT03860428, Not applicable, Completed, Lviv National Medical University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Early Treatment Versus Expectant Management of PDA in Preterm Infants. Trials, record NCT03860428. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03860428

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Early Treatment Versus Expectant Management of PDA in Preterm Infants
NCT number
NCT03860428
Status
Completed
Phases
Not applicable
Enrollment
208 participants, actual
Lead sponsor
Lviv National Medical University
Conditions
Patent Ductus Arteriosus
Interventions
Ibuprofen, Paracetamol, Expectant Management
First posted
2019-03-04
Last updated
2022-04-13

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryIncidence of bronchopulmonary dysplasia (BPD) or mortality at 36 weeks postmenstrual age (PMA)36 weeks PMA
SecondaryPDA re-opening rateDay 1 up to 3 monthPDA re-opening after echocardiographically documented closure
SecondaryClosure rate of PDA within a week after the first and second course of pharmacological treatmentParticipants will be evaluated at the end of first and second course, at an expected avarage of 10 days of life
SecondaryThe need for surgical ductus closureDay 1 up to 3 month
SecondaryDuration of any ventilation assistDay 1 up to 3 monthThe ventilation assist time period
SecondaryDuration of oxygen supplementationDay 1 up to 3 monthDays on supplement oxygen
SecondaryAge of administration of full volume of enteral nutritionDay 1 up to 3 month
SecondaryIncidence of oliguriaIn the first 14 days of life
SecondaryIncidence of hypotensionDay 1 up to 3 month
SecondaryIncidence of BPD36 weeks PMA

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
34147090DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03860428

GET https://conductscience.org/api/trials/v1/NCT03860428/registered