Status:
NOT_YET_RECRUITING
Single-dose Prophylactic INdomethacin in Extremely Preterm Infants
Lead Sponsor:
University of British Columbia
Conditions:
Extreme Prematurity
Intraventricular Hemorrhage
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE2
Brief Summary
In Canada, about 900 babies each year are born very early (\<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies c...
Detailed Description
BACKGROUND \& IMPORTANCE In Canada, about 900 infants are born extremely preterm at \<26 weeks of gestation (GA); nearly four out of 10 of them do not survive or develop severe intraventricular hemorr...
Eligibility Criteria
Inclusion
- Extremely preterm infants born \<26 completed weeks of GA and/or extremely low BW infants born \<750g
Exclusion
- antenatal diagnosis of duct dependent CHD
- acute hypoxic respiratory failure \[defined as fraction of inspired oxygen (FiO2)\>0.60 for ≥2h)
- inhaled nitric oxide (iNO) therapy due to suspected or confirmed acute pulmonary hypertension (PH)
- receipt of prophylactic or therapeutic hydrocortisone
- antenatal diagnosis of renal anomalies
- initial platelet count \<50x109/L
- decision to withhold/withdraw life-sustaining treatments
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2031
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06572917
Start Date
November 1 2025
End Date
March 31 2031
Last Update
September 3 2025
Active Locations (15)
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1
Kaiser Roseville
Roseville, California, United States, 95661
2
UC Davis Health
Sacramento, California, United States, 95817
3
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, United States, 15224-1334
4
Texas Health Harris Methodist Hospital Fort Worth
Fort Worth, Texas, United States, 76104