Multicenter open-label pilot study to evaluate the safety, pharmacology and efficacy of a new dose regimen (i.e. 20-10-10 mg/kg) of Pedea (intravenous ibuprofen) in preterm newborn infants of less than 28 weeks of gestatio

Phase 1

• Conditions: 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

• Registration Number: EUCTR2009-011279-56-FR
• Lead Sponsor: Orphan Europe Recordati

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-15
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

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:
oDuctus diameter > 1.5 mm/kg BW or
oLeft Atrium /Aortic root ratio > 1.4 or
oLeft-right shunt with low velocity (< 1 m/s) through the ductus arteriosus

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

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 < 30000/mm3
- Necrotising enterocolitis
- Severe uncontrolled hyperbilirubinemia (TB > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified