Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

804

Participants

Timeline

Start Date

October 29, 2020

Primary Completion Date

June 20, 2024

Study Completion Date

June 20, 2024

Conditions
Patency of the Ductus ArteriosusAcetaminophenExtreme Prematurity
Interventions
DRUG

Acetaminophen

"In the 27-28 weeks gestational age group, the dosage is 2 ml/kg loading dose within 12 hours after birth followed by 0.75 ml/kg/ 6 hours during 5 days (total = 20 doses).~In the 23-26 weeks gestational age group, the dosage will be minimum effective dose of acetaminophen to close the ductus arteriosus before or at day 7, found during the phase II."

DRUG

NACL 0.9%

"In the 27-28 weeks gestational age group, the dosage is 2 ml/kg loading dose within 12 hours after birth followed by 0.75 ml/kg/ 6 hours during 5 days (total = 20 doses).~In the 23-26 weeks gestational age group, the dosage will be minimum effective dose of acetaminophen to close the ductus arteriosus before or at day 7, found during the phase II."

Trial Locations (36)

2100

The Juliane Marie Centre, Rigshospitalet, Copenhagen University hospital, Copenhagen

13015

Hôpital Marseille Nord, Marseille

31059

Centre Hospitalo-Universitaire de Toulouse, Toulouse

59037

Hopital Jeanne de Flandre, Lille

60126

Azienda Ospedaliero - Universitaria delle Marche, Ancona

69317

Hôpital Croix-Rousse, Lyon

75015

Hôpital Necker - Enfants malades, Paris

Unknown

Centre Hospitalier Universitaire de Liège, Liège

East Tallinn Central Hospital, Tallinn

Tallinn Children's Hospital, Tallinn

Tartu University Hospital, Neonatal and Paediatric Intensive Care Unit, Tartu

Helsinki University Hospital, Department of Children and Adolecents, Neonatology, Helsinki

Kuopio University Hospital, Department of Pediatrics, Kuopio

Oulu University Hospital, Department of Pediatrics, Oulu

Tampere University Hospital, Department of Pediatrics, Tampere

Turku University Hospital, Department of Peadiatrics, Turku

CHU Angers, Angers

Hospice civils de Lyon, Hopital Femme Enfant, Lyon

Hôpital de la conception, Marseille

Hôpital Arnaud de Villeneuve, Département de Pédiatrie Néonatale et Réanimation Pédiatrique, Montpellier

CHU Nantes, Hopital mére Enfant, Nantes

CENTRE hospitalier intercommunal de Creteil, Paris

Hopital Cochin, Service de Médecine et Réanimation néonatales de Port-Royal, Paris

Hopital Robert Debré, Néonatologie, Paris

CHU Rennes, Hopital Sud, Rennes

CHU Strasbourg, Hôpital de Hautepierre, Strasbourg

CHRU de Tours, Tours

Centro Hospitalar Universitário Lisboa Norte, EPE -Hospital Santa Maria, Lisbon

Centro Hospitalar e Universitário do Porto, EPE - Centro Materno Infantil do Norte, Porto

Hopital Universitaire de Geneve (HUG) - Hopital des enfants, Geneva

University Children's Hospital Lausanne, Lausanne

University Hospital of Zürich, Zurich

H6000

Bács Kiskun COUNTY HOSPITAL, Kecskemét

T12 DC4A

Cork University Hospital, Cork

0424

Oslo University Hospital, Oslo

171 64

Karolinska University Hospital, Solna

All Listed Sponsors
collaborator

UPCET

UNKNOWN

collaborator

PARTNERS for International clinical Research

UNKNOWN

collaborator

Connect for Children

UNKNOWN

collaborator

Global Foundation for the Care of Newborn Infants

OTHER

lead

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

NCT04459117 - Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen | Biotech Hunter | Biotech Hunter