Extremely Low Gestatonal Age Infants' Paracetamol Study (Paras)

Outi Aikio

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Other: Placebo; Drug: Paracetamol 10mg/mL infusion solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03641209

39/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: Under 96 hours old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

40 participants in 2 patient groups, including a placebo group

Paracetamol

Experimental group

Description:

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

Treatment:

Drug: Paracetamol 10mg/mL infusion solution

Placebo

Placebo Comparator group

Description:

0.45% sodium chloride (NaCl) solution, equal amounts in mL as would have been given the experimental drug

Treatment:

Other: Placebo