The Effects of Nitric Oxide for Inhalation on the development of chronic lung disease in pre-term infants. - INOT-27

• Conditions: Prevention of chronic lung disease in pre-term infants ( gestational age < 29 weeks) with respiratory distress.; MedDRA version: 7.0Level: LLTClassification code 10054933

• Registration Number: EUCTR2004-002312-29-SE
• Lead Sponsor: INO Therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-12
• Last Update Posted: 16 November 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 800

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

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 <500 grams.
• Infants requiring FiO2 >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

Study & Design

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