Extremely Low Gestational Age Infants' Paracetamol Study: a Randomized Trial
Overview
- Phase
- Phase 1
- Intervention
- Paracetamol 10mg/mL infusion solution
- Conditions
- Prematurity; Extreme
- Sponsor
- Outi Aikio
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Ductal closure
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Outi Aikio
MD, PhD, Docent, Specialist in pediatrics and neonatology
University of Oulu
Eligibility Criteria
Inclusion Criteria
- •Premature infants born before 28+0 gestation weeks and/or birth weight less than 1000g
Exclusion Criteria
- •Severe malformation or suspected chromosomal defect or other very severe life-threatening disease (e.g. very severe birth asphyxia or persistent pulmonary hypertension, etc.)
Arms & Interventions
Paracetamol
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
Intervention: Paracetamol 10mg/mL infusion solution
Placebo
0.45% sodium chloride (NaCl) solution, equal amounts in mL as would have been given the experimental drug
Intervention: Placebo
Outcomes
Primary Outcomes
Ductal closure
Time Frame: Neonatal intensive care unit (NICU) treatment period up to 13 weeks
Postnatal age of the observed closure of ductus arteriosus
Secondary Outcomes
- Mortality(The first hospitalization period up to 19 weeks)
- Complications of prematurity(The first hospitalization period up to 19 weeks)
- Paracetamol serum levels(Study drug period up to 10 days)
- Paracetamol side effects(Neonatal intensive care unit (NICU) treatment period up to 13 weeks)
- Long term morbidity(The first hospitalization period up to 19 weeks)
- PDA, treated(Neonatal intensive care unit (NICU) treatment period up to 13 weeks)
- Near-infrared spectroscopy values(Study drug period up to 10 days)
- PDA(Neonatal intensive care unit (NICU) treatment period up to 13 weeks)
- Ventilatory assist(Neonatal intensive care unit (NICU) treatment period up to 13 weeks)