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The Preterm Infants' Paracetamol Study

NCT01938261 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-10-18

No results posted yet for this study

Summary

Present randomized, controlled, double-blind trial investigates the efficacy and safety of early (\<24 h) intravenous paracetamol therapy for pain medication in very small premature infants. This phase 2 drug study focuses on the efficacy and safety of short-term use. The pharmacokinetics and pharmacodynamics of paracetamol, as well as the long-term effects, are studied.

This study recruits preterm infants born less than 32 weeks gestational age and treated at the neonatal intensive care unit of Oulu University Hospital. The informed consent is asked from all parents. The first drug dose is given before 24 hours of age. Masked study drug is paracetamol infusion solution 10 mg/mL or placebo, 0.45% saline solution. The loading dose is 20 mg/kg, and the maintenance dose 7.5 mg/kg every 6 hours for 4 days. The exact date of the closure of ductus is studied by repeated echocardiographic examinations. The symptoms of pain are screened by a pain scale of preterm infants (NIAPAS). Patients are monitored for signs of possible side effects. After discharge from hospital, patients are examined at follow-up clinic for the first year every 3 months and at 2 years of age.

Conditions

  • Persistent Ductus Arteriosus
  • Complication of Prematurity
  • Pain or Discomfort in Intensive Care of Preterm Infants

Interventions

DRUG

paracetamol

DRUG

0.45 % saline solution

Placebo

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Timo Saarela, M.D., Ph. D. · Oulu University Hospital

  • Mikko Hallman, M.D., Ph.D. · University of Oulu

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
24 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2024-07-15
Completion
2024-08-08

Countries

  • Finland

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01938261 on ClinicalTrials.gov