Patent ductus arteriosus MedDRA version: 16.1 Level: LLT Classification code 10034190 Term: PDA Repair patent ductus arteriosus System Organ Class: 100000004865
Conditions
Interventions
Trade Name: TACHIPIRINA 10 mg/ml soluzione per infusione
Product Name: TACHIPIRINA 10 mg/ml soluzione per infusione
Product Code: 044
Pharmaceutical Form: Solution for infusion
Trade Name: PEDEA 5 mg
Sponsors
Aziende Chimiche Riunite Angelini Francesco ACRAF S.p.A
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female preterm infants with no limitation of race. Gestational age 25+0-31+6 weeks. Age 24-72 hours. Echocardiographic evidence of hemodynamically significant patent ductus arteriosus at the first 24-72 hours of life. The diagnosis of hemodynamically significant PDA requiring treatment will be made by echocardiographic demonstration of a ductal left-to-right shunt, with a left atrium-to-aortic root ratio >1.3 or a ductal size >1.5 mm and excluding the cases in which the closing flow pattern suggests a restrictive PDA [Varvarigou 1996, Su 2008]. Willingness of the parents/legally authorized representative/child to sign the Informed Consent Form. Are the trial subjects under 18? yes Number of subjects for this age range: 110 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: Outborn patients. Major congenital anomalies, including but not limited to congenital heart defects, Down syndrome newborn and/or newborn suffering from congenital anomalies diagnosed during the fetal period. Known positive HIV and/or known positive HCV newborn’s mother. Life threatening infection, complicated or not by multiple organ dysfunction and failure syndrome. Hydrops fetalis. Pulmonary hypertension diagnosed in the first 24-48 hours of life by means of heart ultrasound when the presence of a right-to-left shunt through the foramen ovale or ductus arteriosus is demonstrated, or when the estimated pulmonary pressure, in terms of the tricuspid regurgitation jet, is greater than two-thirds of the systemic arterial pressure. Grade 3 or 4 intraventricular haemorrhage (IVH). Urine output 1.5 mg/dl (132 µmol/l). Platelet count 2 times the upper boundary of the normal range. For this kind of population the following normal ranges will be considered [Rosenthal, 1997]: - ALT/GPT: 6-50 U/L - AST/GOT: 35-140 U/L Medical need of administering other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) different from ibubrofen. Participation to another trial involving any investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study objective is to assess the efficacy and safety of paracetamol in comparison to ibuprofen in the treatment of patent ductus arteriosus in preterm infants.;Secondary Objective: Not applicable;Primary end point(s): Primary end-point: success rate in closing PDA using paracetamol in comparison to ibuprofen after the first 3 days of treatment. ;Timepoint(s) of evaluation of this end point: Day 3 (visit 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints: • number of re-openings at 30 days; • success rate in closing PDA after the second treatment course of ibuprofen as rescue medication; • success rate of closing PDA after the first day and the second day of the first treatment course; • incidence of surgical ligation at 30 days; • incidence of renal failure, liver failure, gastrointestinal complications (including isolated intestinal perforation) at 30 days; • incidence of death at 30 days and at 40 weeks post-conception; • incidence of sepsis at 30 days; • hospital-stay duration in Neonatal Intensive Care Unit; • occurrence of adverse events at 30 days. ;Timepoint(s) of evaluation of this end point: Day 30 (followup 3) or 40 weeks post-conception (follow-up 4) | — |
Countries
Italy
Contacts
Public ContactClinical Trial Application Unit
ACRAF S.p.A
Outcome results
None listed