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 |
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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 |
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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 |
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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 |