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Early Treatment Versus Expectant Management of PDA in Preterm Infants

NCT03860428 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2022-04-13

No results posted yet for this study

Summary

Patent ductus arteriosus (PDA) in very preterm newborns is associated with severe neonatal mor-bidity: intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing en-terocolitis (NEC), retinopathy of prematurity (ROP). Existing methods of management PDA do not reduce the incidence of these diseases. The efficacy of cyclooxygenase inhibitors (COX) which are currently the standard of treatment in extreme preterm infants is about 70-80%. COX inhibitors have significant side effects. On the other hand, surgical ligation of the ductus arteriosus is associated with deterioration due to cardio-pulmonary problems and long-term complications. Paracetamol has been proposed for treatment of hemodynamically significant PDA because it has a different mecha-nism of action compared with COX inhibitors and a better safety profile.

Recently, expectant approach has becoming more popular, although there is not enough evidence to support it.

The objective of this study is to investigate whether in preterm infants, born at a GA less than 32 weeks, with a PDA (diameter \> 1.5 mm) at a postnatal age of \< 72 h, an expectant management is non-inferior to early treatment with regard to the composite of mortality and/or severe morbidity.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

Ibuprofen

In the medical treatment arm the in-tention is to close the ductus arteriosus.

DRUG

Paracetamol

In the medical treatment arm the in-tention is to close the ductus arteriosus.

OTHER

Expectant Management

Expectative PDA management is character-ized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.

Sponsors & Collaborators

  • Lviv National Medical University

    lead OTHER

Principal Investigators

  • Dmytro Dobryanskyy, MD, PhD · L'viv National Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2021-07-20
Completion
2021-07-20

Countries

  • Ukraine

Study Locations

More Related Trials

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 NCT03860428 on ClinicalTrials.gov