Methods | Randomised controlled trial |
Participants | Preterm infants with PMA < 37 weeks, postnatal age ≤ 14 days and with echocardiographically diagnosed PDA with a ductus size of > 1.5 mm and a left atrium to aorta ratio of > 1.2 |
Interventions | The paracetamol group received oral paracetamol 15 mg/kg every 6 h for 3 days. The ibuprofen group received oral ibuprofen 20 mg/kg as an initial dose followed by 10 mg/kg after 24 and 48 h |
Outcomes | Primary outcome: rates of ductal closure on echocardiography after the complete course of both drugs Secondary outcomes: the safety of the drugs and adverse events (e.g. oliguria, IVH, tendency of bleeding, NEC, death). 160 infants were enrolled in the study, but outcomes are reported on 129 infants — 31 infants were excluded. Outcomes reported on 67 infants in the acetaminophen group and 62 in the ibuprofen group |
Notes | We contacted the corresponding author on 10 January 2017 to obtain clarifying information at fasabzvari@gmail.com and again on 18 November 2017. We have not received a response, and therefore we have excluded the trial from the update of the review, as we need more clarifying information. It is not stated what are the denominators for the Clinical Characteristics in Table 1 |