The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants.

Conditions: prevention of chronic lung disease in pre-term infants ( gestational age < 29 weeks) with respiratory distress.
MedDRA version: 14.1Level: PTClassification code 10054933Term: Neonatal respiratory distress syndrome prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2004-002312-29-DE

Lead Sponsor: INO Therapeutics

Brief Summary: Not available

Detailed Description: Not available

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: 800
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

- 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 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