premature infant MedDRA version: 16.0 Level: LLT Classification code 10036615 Term: Prematurity System Organ Class: 100000004868
Conditions
Interventions
Trade Name: Perfalgan 10 mg/ml
Product Name: Perfalgan
Pharmaceutical Form: Solution for infusion
Other descriptive name: PARACETAMOL
Pharmaceutical form of the placebo: Solution for infusion
Route
Sponsors
OYS
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Finland
Contacts
Public ContactOuti Aikio
OYS
Outcome results
None listed