Early Treatment Versus Expectative Management of PDA in Preterm Infants

NACompletedINTERVENTIONAL
Enrollment

273

Participants

Timeline

Start Date

December 23, 2016

Primary Completion Date

March 15, 2022

Study Completion Date

March 15, 2022

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.

Trial Locations (13)

Unknown

University Hospital Antwerp, Antwerp

Hôpital Erasme - Clinique Universitaires de Bruxelles, Brussels

University Hospital Brussels, Brussels

Academic Medical Center, Amsterdam

Free University Amsterdam, Amsterdam

University Medical Center Groningen, Groningen

Leiden University Medical Center, Leiden

Maatricht University Medical Center, Maastricht

Radboudumc Amalia Children's Hospital, Nijmegen

Erasmus Medical Center Rotterdam, Rotterdam

Wilhelmina Children's Hospital/UMCU, Utrecht

Maxima Medical Center, Veldhoven

Isala Kliniek Zwolle, Zwolle

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Radboud University Medical Center

OTHER

NCT02884219 - Early Treatment Versus Expectative Management of PDA in Preterm Infants | Biotech Hunter | Biotech Hunter