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. 2020 Jan 27;2020(1):CD010061. doi: 10.1002/14651858.CD010061.pub4

Al‐Lawama 2017.

Methods Randomised controlled study conducted in the Neonatal Intensive Care Unit of Jordan University Hospital, Amman, Jordan. Study period: from March 2015 to October 2016
Participants Inclusion criteria: preterm infants with a gestational age of ≤ 32 weeks or birth weight of ≤ 1500 g and a haemodynamically significant PDA diagnosed by ECHO.
Exclusion criteria: ductal‐dependent congenital heart diseases, major congenital malformation, grade 3 to 4 intraventricular haemorrhage, renal impairment (defined as a creatinine concentration of > 1.5 mg/dL), pulmonary haemorrhage, thrombocytopenia of < 60,000/mm³ , and an elevated alanine transaminase concentration
Interventions The oral paracetamol group (n = 13) received 10 mg/kg/dose followed by 1 to 2 mL of 0.9% saline every 6 h for 3 days. (10 mg/kg every 6 h for 3 days).
The oral ibuprofen group (n = 9) received 10 mg/kg/dose followed by 1 to 2 mL of 0.9% saline once daily for 3 days. (10 mg/kg/day for 3 days).
The researchers used the same dose for the 3‐day course to minimize errors
Outcomes Primary outcome: mortality, primary PDA closure.
Secondary outcomes: secondary PDA closure, pulmonary haemorrhage, BPD, Sepsis, NEC, ROP, IVH Grade 1 to 2, IVH Grade 3 to 4, PVL
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by computer to receive either oral paracetamol or oral ibuprofen
Allocation concealment (selection bias) Low risk Randomisation numbers were placed inside sequentially numbered opaque envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk There were different scheduling regimens for paracetamol and ibuprofen, so staff were not blinded to the drugs administered
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk It is not stated whether the person conducting ECHO cardiography was blinded to the treatment or not
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All randomised infants are accounted for
Selective reporting (reporting bias) Unclear risk The study was registered: ISRCTN12302923 DOI 10.1186. The study was registered in retrospect when it was completed, so we cannot judge if there were any deviations from the original protocol
Other bias Low risk Appears free of other bias