The Preterm infants’ Paracetamol Study -- PreParaS
Phase 1
- Conditions
- premature infantMedDRA version: 16.0 Level: LLT Classification code 10036615 Term: Prematurity System Organ Class: 100000004868
- Registration Number
- EUCTR2013-001842-33-FI
- Lead Sponsor
- OYS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 240
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To test the efficacy and safety of paracetamol in treatment of preterm infants.;Secondary Objective: ;Primary end point(s): 1. Reduction of the caliber of ductus arterisus 2. decrease of morphin doses 3. closure of ductus arteriosus;Timepoint(s) of evaluation of this end point: 1. end of the study treatment (4 days) 2. time of transform from NICU to normal ward 3. same as 2.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. need for ibuprofein or surgical ligation of ductus arteriosus 2. other diagnoses (BPD, ROP,NEC) 3. pain scores;Timepoint(s) of evaluation of this end point: 1,2 and 3. time of discharge