Status:
COMPLETED
Early Treatment Versus Expectant Management of PDA in Preterm Infants
Lead Sponsor:
Lviv National Medical University
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
Up to 3 years
Phase:
NA
Brief Summary
Patent ductus arteriosus (PDA) in very preterm newborns is associated with severe neonatal mor-bidity: intraventricular hemorrhage (IVH), bronchopulmonary dysplasia (BPD), necrotizing en-terocolitis (...
Eligibility Criteria
Inclusion
- Gestational age \< 32 weeks
- Birthweight \<1500 g
- Age less than 72 hours
- PDA diameter \> 1.5 mm
- Signed informed consent obtained from both parents
Exclusion
- Birthweight ≥ 1500 g and/or gestation age ≥ 32 weeks
- Lack of informed consent of the parents
- Congenital heart defect, other than PDA and/or patent foramen ovale (PFO)
- The presence of a clinically apparent hemorrhagic syndrome
- Any intraventricular hemorrhage (IVH) in the first 48 hours or IVH grade 3-4
- A platelet count of \< 50,000/mm3
- A serum creatinine concentration of \> 110 μmol/L
- Oliguria \<1 ml/kg/h
- Suspected/apparent NEC
- Suspected/apparent lung hypoplasia
Key Trial Info
Start Date :
February 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2021
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT03860428
Start Date
February 15 2019
End Date
July 20 2021
Last Update
April 13 2022
Active Locations (1)
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1
Lviv National Medical University
Lviv, Ukraine, 79010