Status:
RECRUITING
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
Sunnybrook Health Sciences Centre
McMaster Children's Hospital
Conditions:
Patent Ductus Arteriosus After Premature Birth
Eligibility:
All Genders
Up to 27 years
Phase:
PHASE2
Brief Summary
Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, \< 27...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT05340582
Start Date
December 12 2022
End Date
April 1 2027
Last Update
December 4 2025
Active Locations (9)
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1
John Hunter Hospital
Newcastle, New South Wales, Australia, 2300
2
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
3
Royal Alexandra Hospital
Edmonton, Ontario, Canada, T5H 3V9
4
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5