Early Treatment Versus Expectant Management of PDA in Preterm Infants
Patent Ductus Arteriosus
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring PDA, Ibuprofen, Paracetamol, Expectant management
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Lviv National Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Sham Comparator
Rectal ibuprofen
Intravenous paracetamol
Expectant Treatment
Early treatment of PDA that starts within the first 3 days of life using rectal ibuprofen q24h for 3 days, dosages: 20 mg/kg + 10 mg/kg + 10 mg/kg
Early treatment of PDA that starts within the first 3 days of life using intravenous paraceta-mol 15 mg/kg q6h for 3 days
Expectant PDA management is characterized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA unless defi-nitely needed based of the predefined infant's condition.