Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After Premature Birth
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus After Premature Birth focused on measuring Preterm Neonates, Patent Ductus Arteriosus, Echocardiography, Acetaminophen, Ibuprofen
Eligibility Criteria
Inclusion Criteria:
- Preterm infants born <27+0 weeks gestational age
- Permission given by the attending clinician to approach and then consent obtained from parents
- Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt
- Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.
Exclusion Criteria:
- Chromosomal anomaly
- Pre-treatment renal dysfunction defined as urine output < 1ml/kg/hour for the previous 24 hours or serum creatinine > 100 micromol/L
- Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) > 100 units/L94
- Platelet count <50,000 per microliter
- Permission denied by the attending clinician to approach parents
- Parental consent not available
- Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).
Sites / Locations
- McMaster Children's HospitalRecruiting
- Sunnybrook Health Sciences CentreRecruiting
- Mount Sinai HospitalRecruiting
- The Rotunda Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Combination Therapy
Standard Clinical Practice - Monotherapy
Intravenous or enteral ibuprofen, as decided by clinical team, in the standard clinical dose used in participating NICUs (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) And study drug (intravenous acetaminophen 15 mg/kg/dose IV q6h for 3 days).
Intravenous or enteral ibuprofen, as decided by clinical team, in the standard clinical dose used in participating NICUs (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) And Placebo [(0.9% saline IV q6h for 3 days).