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Extremely Low Gestatonal Age Infants' Paracetamol Study

NCT03641209 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-03-15

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Paracetamol 10mg/mL infusion solution

Intravenous paracetamol solution for infusion

OTHER

Placebo

Half physiological saline solution as the non-active placebo solution

Sponsors & Collaborators

  • Outi Aikio

    lead OTHER

Principal Investigators

  • Outi Aikio, MD, PhD · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
96 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-03
Primary Completion
2023-11-03
Completion
2024-03-01

Countries

  • Finland

Study Locations

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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 NCT03641209 on ClinicalTrials.gov