Sosenko 2012.
| Methods | Single centre, double‐blind, randomised controlled trial conducted in Miami, Florida, US. Study period January 2008 to August 2010 | |
| Participants | Infants born with BW 500 to 1250 g and PMA 23 to 32 weeks, who were > 24 hours old but ≤ 14 days old and who had ECHO for subtle PDA symptoms (metabolic acidosis, murmur, bounding pulses) | |
| Interventions | 'Early' treatment: 54 infants, blinded ibuprofen 'Expectant' management: 51 infants, blinded placebo If the PDA became haemodynamically significant (pulmonary haemorrhage, hypotension, respiratory deterioration), infants received open‐label ibuprofen. Infants with haemodynamically significant PDA at enrolment were excluded from the study The dosing schedule for ibuprofen was an initial dose of 10 mg/kg, followed by 2 doses of 5 mg/kg each, every 24 hours, by slow IV infusion; dosing of placebo involved equivalent volumes of dextrose by slow IV infusion on the same schedule |
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| Outcomes | Days on supplemental oxygen during the first 28 days of life, mortality during hospital stay, supplemental oxygen at 36 weeks' PMA, intestinal perforation, NEC requiring surgery, IVH (grades III‐IV), PVL, sepsis and ROP (stage ≥ 3) | |
| Notes | After 105 of 168 infants were enrolled, the study drug (NeoProfen) was recalled by the manufacturer and was no longer available in the US. The study was supported by an unrestricted grant from Ovation (now Lundbeck) Pharmaceuticals and University of Miami | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Random number table |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Clinicians, investigators, and nursing staff were blinded to the study group to which the infant was assigned and the medication the infant was receiving. Only the neonatal pharmacists were aware of the study group of each infant and were responsible for preparing the "blinded" ibuprofen or "blinded" placebo study drug |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | As per above |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all enrolled infants |
| Selective reporting (reporting bias) | Low risk | This study was registered, #NCT00802685, and there did not seem to be any deviations from the protocol, except that the study had to be stopped when the study drug was no longer available |
| Other bias | Low risk | Appeared free of other bias |