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Early Treatment Versus Expectative Management of PDA in Preterm Infants

NCT02884219 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 273

Last updated 2023-07-03

No results posted yet for this study

Summary

Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age \<28 weeks and/or a birth weight ≦1000 grams due to a lack of evidence for or against different approaches. A PDA has been associated with serious complications. However, a common finding is that medical and/or surgical treatment of a PDA seems not to reduce the risk of mortality or major morbidity. This might be related to the fact that a substantial portion of preterm infants are treated unnecessarily, because the ductus arteriosus (DA) might have closed spontaneously without any specific intervention. An expectative approach is gaining interest, although convincing evidence is still missing.

The objective of this study is to investigate whether in preterm infants \<28 weeks' gestation with a PDA an expectative management is not inferior to early treatment with regard to the composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary dysplasia (BPD) at a postmenstrual age of 36 weeks.

Conditions

  • Patent Ductus Arteriosus

Interventions

DRUG

Ibuprofen

In the medical treatment (COXi) arm the intention is to close the ductus arteriosus.

OTHER

Expectative Management

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

DRUG

Indomethacin

In the medical treatment (COXi) arm the intention is to close the ductus arteriosus.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Willem P de Boode, MD PhD · Radboud University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-23
Primary Completion
2022-03-15
Completion
2022-03-15

Countries

  • Belgium
  • Netherlands

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 NCT02884219 on ClinicalTrials.gov