Extremely Low Gestatonal Age Infants' Paracetamol Study
- Conditions
- Prematurity; ExtremeLow Birthweight, Extremely (999 Grams or Less)
- Interventions
- Other: Placebo
- Registration Number
- NCT03641209
- Lead Sponsor
- Outi Aikio
- Brief Summary
In the present trial, early, intravenous paracetamol is compared to placebo in extremely premature or low birth weight infants in order to evaluate the effect on ductal closure.
- Detailed Description
The purpose of this randomized, placebo-controlled, double-blind, phase 2, one center clinical trial is to study the efficacy and safety of early (\< 96 h) intravenous paracetamol in prophylactic closure of ductus arteriosus in extremely premature (gestational age \<28+0 wk, ELGA) or low birth weight (\<1000 g, ELBW) infants. The infants born extremely preterm or low birth weight are a focus of the study, since a small phase 2 study on paracetamol failed to demonstrate contraction of ductus arteriosus.
In the investigator's previous cohort of ELGA/ELBW infants, the numbers of patients who needed any therapies for patent ductus arteriosus (PDA) were 29 (23%) in the paracetamol exposed group, and 90 (54%) in the control group. As demonstrated in a phase 2 study, the early paracetamol treatment induced the closure of ductus arteriosus: the mean (SD) ductal closure age was 177 (338) h in the whole paracetamol group. However, in the subgroup of ELGA infants born before 28 gestation weeks (n=14), the mean (SD) ductal closure ages in the paracetamol and placebo groups were 491 (504) h and 858 (719) h, respectively.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Premature infants born before 28+0 gestation weeks and/or birth weight less than 1000g
- Severe malformation or suspected chromosomal defect or other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 0.45% sodium chloride (NaCl) solution, equal amounts in mL as would have been given the experimental drug Paracetamol Paracetamol 10mg/mL infusion solution Paracetamol 10 mg/mL infusion solution, intravenous loading dose 20 mg/kg, followed by maintenance dose 7.5 mg/kg every 6 h up to 9 days
- Primary Outcome Measures
Name Time Method Ductal closure Neonatal intensive care unit (NICU) treatment period up to 13 weeks Postnatal age of the observed closure of ductus arteriosus
- Secondary Outcome Measures
Name Time Method Mortality The first hospitalization period up to 19 weeks Mortality
Complications of prematurity The first hospitalization period up to 19 weeks The long term complications of prematurity (moderate-to-severe bronchopulmonary dysplasia (BPD), intraventricular hemorrhage gr 2-4, moderate to severe necrotizing enterocolitis, retinopathy of prematurity (ROP) needing therapy)
Paracetamol serum levels Study drug period up to 10 days Paracetamol serum levels
Paracetamol side effects Neonatal intensive care unit (NICU) treatment period up to 13 weeks Any observed or detected paracetamol side effects
Long term morbidity The first hospitalization period up to 19 weeks Other long-term morbidity
PDA, treated Neonatal intensive care unit (NICU) treatment period up to 13 weeks The need for PDA therapies (ibuprofen, paracetamol, ligation)
Near-infrared spectroscopy values Study drug period up to 10 days Near-infrared spectroscopy values
PDA Neonatal intensive care unit (NICU) treatment period up to 13 weeks Open ductus arteriosus without any traditional PDA therapies
Ventilatory assist Neonatal intensive care unit (NICU) treatment period up to 13 weeks The duration of any ventilation assist, days
Trial Locations
- Locations (1)
Department of Pediatrics, Oulu University Hospital
🇫🇮Oulu, Finland