Clinical trial

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

Name

39/2018

Description

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.

Trial arms

Trial start

2018-09-03

Estimated PCD

2023-11-03

Trial end

2024-03-01

Status

Completed

Phase

Early phase I

Treatment

Paracetamol 10mg/mL infusion solution

Intravenous paracetamol solution for infusion

Arms:

Paracetamol

Other names:

acetaminophen, Paracetamol Fresenius Kabi 10 mg/mL infusion solution

Placebo

Half physiological saline solution as the non-active placebo solution

Arms:

Placebo

Other names:

Natriumklorid Braun 4,5mg/mL solution for infusion

Size

Primary endpoint

Ductal closure

Neonatal intensive care unit (NICU) treatment period up to 13 weeks

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.)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, one center trial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "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.", 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}

Updated at

2024-03-15

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication

Extremely Low Birth Weight