Paracetamol versus ibuprofen, (a drug that represents the standard treatment in this condition) to treat preterm infants with Perstent Ductus Arteriosus unclosure that is without sponatanous clousure at the

Phase 1

Conditions: patent ductus arteriosus hemodynamically important
MedDRA version: 17.0Level: LLTClassification code 10034190Term: PDA Repair patent ductus arteriosusSystem Organ Class: 100000004865
Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Registration Number: EUCTR2013-004955-19-IT

Lead Sponsor: Azienda Ospedaliera di Padova

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 116

Inclusion Criteria

•inborn neonates
•preterm neonates = 31+ 6 days weeks gestation
•< 72 hours of life
•newborns with HsPDA
•parental written informed consent for participation in the study must be obtained

Are the trial subjects under 18? yes
Number of subjects for this age range: 116
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

•Serum creatinine concentration greater than 1,5 mg/dl (132 ?Mole/L)
•Urine output less than 1 ml/Kg/h with adeguate fluid intake (70-90 ml/kg/die)
•Severe IVH (> grade II according to Volpe classification)
•Clinical bleeding tendency (as revealed by hematuria, blood in the gastric aspirate or in the stools, blood in the endotracheal tube aspirate)
•Necrotizing enterocolitis or marked abdominal distention with gastric bile residuals
•Thrombocyte count of less than 50.000/mm3
•Proved Sepsis
•Severe coagulopathy or liver failure
•Evidence of severe birth asphyxia, that is an APGAR score below 5 at 5 minutes of age and/or umbilical arterial pH < 7.0
•Known genetic or chromosomal disorders
•Participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy and safety of 2 therapeutic regimens for PDA treatment ( paracetamolo vs ibuprofen) in a population of preterm newborns of GA <31+6 weeks with respiratory distress syndrome (RDS) and HsPDA:;Secondary Objective: To evaluate the safety of the 2 therapeutic regimens of paracetamol or ibuprofen.;Primary end point(s): The rate of ductal closure after the first and second course of pharmacological treatment. (PDA diagnosed by ECHO criteria);Timepoint(s) of evaluation of this end point: The percentage of patients with ductal closure obtained during the study period by echocardiographic evaluation performed after the first three doses, the second three doses, by one week from the end of pharmacological treatment and at discharge. The need of rescue therapy (third course), the rate of reopening and surgical legation will be also considered.

Secondary Outcome Measures