Extremely Low Gestatonal Age Infants' Paracetamol Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-03

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, one center trial

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Placebo, 0.45 % saline, is similar to paracetamol, both being clear liquids, so the staff will remain unaware which drug the patient receives. The study drug will be kept and prepared away from the NICU, at the separate ward 55 office, in a locked cabinet. The study drug will be prepared by the research nurse, the pharmacist of the ward, or during nighttime, by a nurse who does not participate in the study patients' treatment in any way.

Study Groups

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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

Group Type EXPERIMENTAL

Paracetamol 10mg/mL infusion solution

Intervention Type DRUG

Intravenous paracetamol solution for infusion

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Half physiological saline solution as the non-active placebo solution

Interventions

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Paracetamol 10mg/mL infusion solution

Intravenous paracetamol solution for infusion

Intervention Type DRUG

Placebo

Half physiological saline solution as the non-active placebo solution

Intervention Type OTHER

Other Intervention Names

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acetaminophen Paracetamol Fresenius Kabi 10 mg/mL infusion solution Natriumklorid Braun 4,5mg/mL solution for infusion

Eligibility Criteria

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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.)

Maximum Eligible Age

96 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No