Safety of paracetamol in neonates

Phase 1

• Conditions: Liver toxicity following prolonged administration of i.v. or oral paracetamol; MedDRA version: 20.1 Level: LLT Classification code 10019850 Term: Hepatotoxic effect System Organ Class: 100000004871; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2017-002724-25-DK
• Lead Sponsor: Helle Holst

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-07
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

•Neonates any gestational age and weight of both genders
•Post menstrual age up to 44 full weeks at inclusion
•Intended treatment with i.v. paracetamol for any indication or intended treatment with p.o. paracetamol for one of the following indications: fractures, cranial haemorrhages, chest tubes, postoperative pain or painfull skin lessions.
•Informed written consent from both parents or legal guardian, Informed Consents must be approved by the Danish Ethical Committee
•Signing consent form can be postponed 24 hours after treatment start

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•The responsible clinicians finds the patient unsuitable for trial
•Hypersensitivity towards paracetamol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified