Open ductus arteriosus of a premature infant
Conditions
Interventions
Trade Name: Paracetamol Fresenius Kabi
Product Name: Paracetamol Fresenius Kabi
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paracetamol
Other descriptive name: PARACETAMOL
Concentr
Sponsors
University of Oulu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All extremely premature (born before 28 gestation weeks) or low birth weight (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Denial by the parents - Severe congenital or chromosomal anomaly or severe clinical situation, that complicates the standard ductal therapies e.g. asphyxia, or persistent pulmonary hypertension of a newborn
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Cardiac ultrasound findings, ductal therapies, duration of the ventilation assist, paracetamol serum concentrations, possible paracetamol side effects, complications of prematurity, neonatal and long term morbidity and mortality ;Timepoint(s) of evaluation of this end point: - discharge to home | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the efficacy and safety of intravenous paracetamol in contracting ductus arteriosus of a very premature (<28 gestation weeks) or extremely low birth weight (<1000 g) infants ;Secondary Objective: Not applicable;Primary end point(s): Shortening of the ductal closure time;Timepoint(s) of evaluation of this end point: - after the study drug period - at the discharge from the NICU | — |
Countries
Finland
Contacts
Public ContactDepartment of Pediatrics
University of Oulu
Outcome results
None listed