Prevention of chronic lung disease in pre-term infants ( gestational age < 29 weeks) with respiratory distress. MedDRA version: 7.0 Level: LLT Classification code 10054933
Conditions
Interventions
Trade Name: INO max® (Nitric Oxide for Inhalation, 400 ppm)
Product Name: INO max® (Nitric Oxide) for inhalation (400 ppm)
Product Code: N/A
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: ni
Sponsors
INO Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patient must meet the following criteria: • Inborn preterm infants 24+0 weeks–28+6 days weeks gestational age (defined by first trimester ultrasound or if not available based on the last menstrual period) who requires the use of surfactant within 24 hours of birth, (either prophylactically or for signs of developing respiratory distress), or who requires the use of CPAP (FiO2 = 0.30 and mean airway pressure = 4cm H2O) within 24 hours of birth in order to maintain an SpO2 = 85%. • Informed consent of the parent or legal guardian. CPAP = Continuous Positive Airway Pressure SpO2 = Oxygen saturation by pulse oximeter 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
Exclusion criteria: The patient will be excluded from enrollment if any of the following are true: • Outborn infants. • Infants = 29 weeks gestational age. • Infants with birth weight 0.5 to maintain SpO2 >85%, on a sufficient mean airway pressure (e.g., > 8 cm H2O on CMV) in order to achieve adequate chest inflation (8-9 ribs on Chest X-ray) two hours after the proper administration of exogenous surfactant. • Any suspected congenital heart disease other than patent ductus arteriosus or atrial septal defect. • Any infant with suspected lung hypoplasia associated with congenital diaphragmatic hernia • Any infant with severe bleeding and/or coagulation abnormalities at high-risk of diathesis, e.g., platelet <50,000/mm3, fibrinogen <0.5 g/L, other clotting factors <10%. • Any infant in whom a decision has been made not to provide full treatment, e.g., chromosomal abnormalities, severe multiple abnormalities, severe birth asphyxia, etc. • Use of another investigational drug or device before or during the active study period. CMV = Controlled Mechanical Ventillation. FiO2 = Fraction of inspired oxygen concentration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress and to assess the long term effects of the therapy on the development of these children over 7 years of clinical follow up. ;Secondary Objective: To assess: -number of days of assisted ventilation. -length of hospitalisation. -Survival without severe IVH, and PVL. - total number of days in-hospital from 36 weeks GA to one year and two years corrected age. - average number of days in-hospital for respiratory illness from 36 weeks GA to one year and two years corrected age. GA- gestational age IVH - intraventricular hemorrhage PVL - periventricular leukomalacia;Primary end point(s): Primary Efficacy Variable The primary efficacy variable for this study will be a binary endpoint determined by assessment at 36 week post-menstrual age (PMA). An infant who is alive without CLD at 36 PMA will be counted as a ‘success’. An infant who has died, or who has CLD at 36 weeks PMA will be counted as a ‘failure’. CLD is defined as the need for supplemental oxygen at 36 weeks post-menstrual age (based on a physiologic assessment). PMA = Post-menstrual age CLD = chronic lung disease | — |
Countries
Belgium, Finland, Germany, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed