Härkin 2016.
| Methods | Randomised controlled trial conducted in the neonatal intensive care unit of Oulu University Hospital, Oulu, Finland. Study period: 18 September 2013 to 2 January 2015 | |
| Participants | Very low gestational age (< 32 weeks) infants requiring intensive care (n = 48). All infants had a PDA diagnosed by ECHO before the study drug was given and then an ECHO was performed once a day until 1 day after the study medication period | |
| Interventions | The paracetamol group (n = 23) received an IV loading dose of 20 mg/kg, given within 24 h of birth, followed by a maintenance dose of 7.5 mg/kg every 6 h for 4 days, given as 15‐min infusions The placebo group (n= 25) received 0.45% NaCl IV |
|
| Outcomes | Primary outcomes: decrease in ductal calibre without side effects; and failure to close a PDA by 4 to 5 days Secondary outcomes: persistent PDA treated, oliguria (< 1 mL/kg/h), polyuria (> 5 mL/kg/h), hypernatraemia (> 150 mmol/L), sepsis, supplemental oxygen at 28 days, supplemental oxygen at 36 weeks' PMA, ROP treated, IVH grades 1 to 2, IVH grades 3 to 4, NEC stage 3, death, days of supplemental oxygen, highest serum bilirubin ( µmol/L) |
|
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computed randomisation was performed using a 4‐block design |
| Allocation concealment (selection bias) | Low risk | The treatment allocation codes were sealed in sequentially labelled opaque envelopes. Both paracetamol and saline solutions appeared equally transparent in the syringe |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | All nurses and doctors involved in the treatment and study of the infants were blinded to the study medication |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | A separate team of nurses prepared the study drug in a study pharmacy outside NICU. The drug was given to the study patient’s nurse in a syringe |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcomes reported for all randomised infants |
| Selective reporting (reporting bias) | Low risk | The study was registered in ClinicalTrials.gov: NCT01938261; European Clinical Trials Database: EudraCT 2013‐008142‐33. No deviations from the protocols were noted |
| Other bias | Low risk | Appears free of other bias |