Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus (PAI)
Patent Ductus Arteriosus
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring acetaminophen, ibuprofen, preterm infant, near infra-red spectroscopy, indomethacin
Eligibility Criteria
Inclusion Criteria:
- Preterm infants (born before 37+0 gestation weeks) who are diagnosed to have a hemodynamically significant PDA and who, according to the decision of the attending clinician, need ibuprofen therapy, are eligible to this trial.
Exclusion Criteria:
- severe malformation or suspected chromosomal defect
- other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
Sites / Locations
- Helsinki Univeristy Central HospitalRecruiting
- Department of Pediatrics, Oulu University HospitalRecruiting
- Tampere University Hospital
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Pedea 5mg/mL and Paracetamol 10mg/mL
Pedea 5mg/mL and 0.45 sodium chloride
Indomethacin 25mg/mL and Paracetamol10mg/mL
Indomethacin 25mg/mL and 0.45 sodium chloride
Intravenous (IV) ibuprofen 5mg/mL q 24h for 3 days, dosages: 10mg/kg + 5mg/kg + 5mg/kg and IV paracetamol 10mg/mL for 3 days: loading dose 20mg/kg, following 7.5mg/kg q 6h (up to12 doses)
IV ibuprofen 5mg/mL q 24h for 3 days, dosages: 10mg/kg + 5mg/kg + 5mg/kg and NaCl 0.45% for 3 days, the same amount in mL as would have been given IV paracetamol
Intravenous (IV) indometahcin 25mg/mL q 24h for 3 days, dosages: 0.2mg/kg + 0.1mg/kg + 0.1mg/kg and IV paracetamol 10mg/mL for 3 days: loading dose 20mg/kg, following 7.5mg/kg q 6h (up to12 doses)
Intravenous (IV) indomethacin 25mg/mL q 24h for 3 days, dosages: 0.2mg/kg + 0.1mg/kg + 0.1mg/kg and NaCl 0.45% for 3 days, the same amount in mL as would have been given IV paracetamol