| Trial name or title | Preterm infants' paracetamol study (PreParaS) |
| Methods | Randomised placebo‐controlled study |
| Participants | Preterm infants born at < 32 weeks PMA |
| Interventions | Placebo comparator: paracetamol effect on ductus. First drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL (PERFALGAN®) or placebo, 0.45% saline solution. Loading dose is 20 mg/kg, and maintenance dose is 7.5 mg/kg every 6 hours for 4 days. Placebo comparator: paracetamol effect on pain. First drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL (PERFALGAN®) or placebo, 0.45% saline solution. Loading dose is 20 mg/kg, and maintenance dose is 7.5 mg/kg every 6 hours for 4 days. |
| Outcomes | For PDA: ductus diameter mm/kg at postnatal age of 5 days For pain: cumulative dosage of morphine at postnatal age of 5 days |
| Starting date | August 2013 |
| Contact information | Outi Aikio, MD, PhD + 358 8 3155810 outi.aikio@ppshp.fi |
| Notes |
PMA = postmenstrual age.