Single-dose Prophylactic INdomethacin in Extremely Preterm Infants

Phase 3

Not yet recruiting

• Conditions: Extreme Prematurity; Morbidity; Newborn; Intraventricular Hemorrhage

• Registration Number: NCT06572917
• Lead Sponsor: University of British Columbia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Inclusion Criteria:<br><br> - Extremely preterm infants born <26 completed weeks of GA and/or extremely low BW<br> infants born <750g<br><br>Exclusion Criteria:<br><br> - antenatal diagnosis of duct dependent CHD<br><br> - acute hypoxic respiratory failure [defined as fraction of inspired oxygen<br> (FiO2)>0.60 for =2h)<br><br> - inhaled nitric oxide (iNO) therapy due to suspected or confirmed acute pulmonary<br> hypertension (PH)<br><br> - receipt of prophylactic or therapeutic hydrocortisone<br><br> - antenatal diagnosis of renal anomalies<br><br> - initial platelet count <50x109/L<br><br> - decision to withhold/withdraw life-sustaining treatments

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival without severe intraventricular hemorrhage (sIVH)

Secondary Outcome Measures

Name	Time	Method
Mortality;Severe IVH;Gastrointestinal perforation;Necrotizing enterocolitis (NEC);Acute kidney injury (AKI);Persistent patent ductus arteriosus;Procedural PDA closure;Chronic pulmonary hypertension;Grade 3 Bronchopulmonary dysplasia (BPD);Pulmonary hemorrhage;Duration of invasive mechanical ventilation in days;Postnatal corticosteroid use;IVH (any grade);Periventricular leukomalacia (any grade);White matter injury (WMI);Severe retinopathy of prematurity (ROP);Major neurodevelopmental impairment