Extremely low gestational age infants' PARAcetamol Study

Phase 1

Conditions: Open ductus arteriosus of a premature infant
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2018-000566-11-FI

Lead Sponsor: niversity of Oulu

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

All extremely premature (born before 28 gestation weeks) or low birth weight (< 1000 g) infants treated in neonatal intensive care unit of Oulu University Hospital and who have an open ductus
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>- at the discharge from the NIC

Secondary Outcome Measures

Name	Time	Method
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