Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2013-001842-33-FI
EUCTR2013-001842-33-FI
Active, not recruiting
Phase 1

The Preterm infants’ Paracetamol Study -- PreParaS - PreParaS

OYS0 sites240 target enrollmentJune 20, 2013
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionspremature infantMedDRA version: 16.0 Level: LLT Classification code 10036615 Term: Prematurity System Organ Class: 100000004868
DrugsPerfalgan 10 mg/ml

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
premature infant
Sponsor
OYS
Enrollment
240
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 20, 2013
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
OYS

Eligibility Criteria

Inclusion Criteria

  • •Preterm infants less than 32 gestation weeks
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 48
  • •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

  • •1\. No permission from the parents, 2\. major congenital anomaly 3\. cromosomal anomaly 4\. any other severe clinical situation that complicates essentially the initial treatment of premature infant.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Phase 1
Extremely Low Gestatonal Age Infants' Paracetamol StudyPrematurity; ExtremeLow Birthweight, Extremely (999 Grams or Less)
NCT03641209Outi Aikio40
Completed
Phase 2
The Preterm Infants' Paracetamol StudyPersistent Ductus ArteriosusComplication of PrematurityPain or Discomfort in Intensive Care of Preterm Infants
NCT01938261University of Oulu120
Active, not recruiting
Phase 1
Extremely low gestational age infants' PARAcetamol StudyOpen ductus arteriosus of a premature infantTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
EUCTR2018-000566-11-FIniversity of Oulu40
Active, not recruiting
Phase 1
Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.Persistent ductus arteriosus haemodynamically significantTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
EUCTR2015-003177-14-ES
Active, not recruiting
Not Applicable
Paracetamol, administered directly into a vein in babies born after a pregnancy of less than 32 weeks
EUCTR2010-019678-34-NL