Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants

PHASE2RecruitingINTERVENTIONAL
Enrollment

310

Participants

Timeline

Start Date

December 12, 2022

Primary Completion Date

January 31, 2027

Study Completion Date

April 30, 2027

Conditions
Patent Ductus Arteriosus After Premature Birth
Interventions
DRUG

Acetaminophen Injection

Acetaminophen injection solution 1000 mg/100 mL (10 mg/mL) latex-free plastic bag - dosage for this protocol is 15mg/kg/dose IV four times a day for 3 days

DRUG

Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen)

Ibuprofen is not a study drug - standard of care in participating NICUs in the standard clinical dose for neonates (typically, for neonates \< 7 days old - 10 mg/kg/dose on day 1, 5 mg/kg/dose q24h on days 2 and 3; for neonates \> 7 days old - 20 mg/kg/dose on day 1, 10 mg/kg/dose q24h on days 2 and 3)

OTHER

Sodium chloride 0.9% injection

Placebo- IV q6h for 3 days

Trial Locations (9)

2065

ACTIVE_NOT_RECRUITING

Royal North Shore Hospital, St Leonards

2300

ACTIVE_NOT_RECRUITING

John Hunter Hospital, Newcastle

T5H 3V9

NOT_YET_RECRUITING

Royal Alexandra Hospital, Edmonton

L8N 3Z5

RECRUITING

McMaster Children's Hospital, Hamilton

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

M5G 1X5

RECRUITING

Mount Sinai Hospital, Toronto

G1V 4G2

NOT_YET_RECRUITING

Centre Hospitalier de l'Université Laval, Québec

Unknown

NOT_YET_RECRUITING

Prince of Wales Hospital, Shatin

RECRUITING

The Rotunda Hospital, Dublin

All Listed Sponsors
collaborator

Sunnybrook Health Sciences Centre

OTHER

collaborator

McMaster Children's Hospital

OTHER

collaborator

The Rotunda Hospital

OTHER

collaborator

John Hunter Hospital

OTHER_GOV

collaborator

Royal Alexandra Hospital

OTHER

collaborator

Centre Hospitalier de l'Universite Laval (CHUL)

UNKNOWN

collaborator

Royal North Shore Hospital

OTHER

collaborator

Prince of Wales Hospital, Shatin, Hong Kong

OTHER

lead

Mount Sinai Hospital, Canada

OTHER