Hemodynamically significant persisting ductus arteriosus in preterm infants of less than 28 weeks of gestational age MedDRA version: 9.1 Level: LLT Classification code 10034130 Term: Patent ductus arteriosus
Conditions
Interventions
Trade Name: Pedea
Product Name: Pedea
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ibuprofen
CAS Number: 15687-27-1
Sponsors
Orphan Europe Recordati
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants fulfilling the following criteria will be selected for participation in the study: - Written parental informed consents - Gestational age less than 28 weeks of amenorrhoea (up to 27 6/7 weeks) - Neonates aged minimum 12 hours of life and maximum 72 hours of life - Dependent on mechanical or non-invasive ventilation - Carrying a venous umbilical catheter - Presenting with an Hs PDA, defined as the evidence of a blood flow through the ductus arteriosus (left-to-right shunt) and/or of retrograde blood flow in the main pulmonary artery with colour Doppler and/or pulse Doppler with at least one of the following: o Ductus diameter > 1.5 mm/kg BW or o Left Atrium /Aortic root ratio > 1.4 or o Left-right shunt with low velocity (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Neonates presenting with one of the following criteria will not be included in the study: - Ductus-dependent cardiopathy - Right-to-left shunt over a persisting ductus arteriosus - Hydrops fetalis - Severe intra-ventricular haemorrhage (Papile’s grade 3 or 4) - Neurological functional disorders: seizures, coma - Life threatening infection - Thrombocytopenia 171 µmol/L or 10 mg/dL) - Hepatocellular disease, hepatic insufficiency and/or hypoalbuminemia < mean reference value - 1 SD for the corrected gestational age (Reading RF, et al 1990) - Urine output below 1 mL per kilogram of birth weight per hour during the last 12 hours - Plasma creatinine concentration = 140 µmol/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether the administration of Pedea® (intravenous ibuprofen) starting between 12 and 72 hours of life at a dose regimen of 20-10-10 mg/kg is safe and well tolerated in a population of preterm newborn infants of less than 28 weeks of GA treated for a hemodynamically significant PDA.; Secondary Objective: To determine at serial time points: 1 Plasma concentrations of ibuprofen enantiomers; 2 Plasma concentrations of total and unbound unconjugated bilirubin; To evaluate the global PDA closure rate after treatment course. ; Primary end point(s): - An echocardiography will be performed to assess the status of the ductus 72 hours after the start of the first dose of ibuprofen. - Closure of the PDA will be defined by the absence of blood flow through the ductus and of retrograde flow in the pulmonary trunk, as evidenced by color and pulsed-wave Doppler. - The size (diameter) of the ductus arteriosus will be documented if it remains patent. | — |
Countries
France
Outcome results
None listed