Status:
RECRUITING
PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Patent Ductus Arteriosus After Premature Birth
Eligibility:
All Genders
Up to 29 years
Phase:
PHASE4
Brief Summary
Babies who are born very prematurely are often born with murmurs in the heart. In preterm babies, one of the most common causes of murmur is the presence of a PDA. This is the persistence of a connect...
Eligibility Criteria
Inclusion
- Preterm infants less than (\< )29 weeks gestation at birth
- Echocardiographic evidence of hsPDA (as outlined in the NICU PDA treatment guidelines) at 7-21 days of life requiring pharmacologic treatment as determined by the managing physician.
Exclusion
- Not able to consent for any reason
- Preterm infants with congenital heart disease except for PDA, PFO (patent foramen ovale), small and restrictive ASD (atrial septal defect), or small VSD (ventricular septal defect).
- Preterm infants with lethal genetic malformations.
- Preterm infants with congenital abdominal wall defects (omphalocele, gastroschisis).
- Preterm infants with congenital or acquired brain anomaly.
- Infants who receive ibuprofen for PDA treatment during the first week of life will be excluded. We will recruit infants between day 7 and 21 only because high-dose ibuprofen is not indicated during the first week of life
- Preterm infants with contraindications to Ibuprofen therapy, including severe intraventricular hemorrhage (IVH), low platelet count \< 50,000 platelets per microliter, renal impairment with creatinine \>160 mmol/L or necrotizing enterocolitis (NEC) \> Stage 2 (using modified bell's Criteria).
- Preterm infants with spontaneous intestinal perforation (SIP).
- Acute kidney injury (defined as an increase in serum creatinine of 50% or more from the previous lowest value or a urinary output of less than 1 mL/kg per hr.).
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05325177
Start Date
June 1 2022
End Date
December 31 2024
Last Update
January 30 2024
Active Locations (1)
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1
The Ottawa General Hospital
Ottawa, Canada