NCT03641209

Extremely Low Gestatonal Age Infants' Paracetamol Study

Extremely Low Gestational Age Infants' Paracetamol Study: a Randomized Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Outi Aikio · Academic / Other
• Sex: All
• Age: 96 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity; Extreme
• Low Birthweight, Extremely (999 Grams or Less)

Interventions

Type	Name	Description
DRUG	Paracetamol 10mg/mL infusion solution	Intravenous paracetamol solution for infusion
OTHER	Placebo	Half physiological saline solution as the non-active placebo solution

Timeline

• Start date: 2018-09-03
• Primary completion: 2023-11-03
• Completion: 2024-03-01
• First posted: 2018-08-21
• Last updated: 2024-03-15

Locations

1 site across 1 country: Finland