• Chronic Lung Disease [ Time Frame: 36 weeks GA ] [ Designated as safety issue: No ]
• Survival [ Time Frame: 36 Weeks GA ] [ Designated as safety issue: No ]

• Vital Signs [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
• Arterial Oxygen Saturation by Pulse Oximetry [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
• Adverse Events [ Time Frame: Study Duration ] [ Designated as safety issue: Yes ]
• Methemoglobin Level [ Time Frame: Baseline, then 24 hours, 2-6 days, Day 7 and Day 14 of treatment ] [ Designated as safety issue: Yes ]

The purpose of this study is 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.

Although the effects of inhaled NO on pulmonary vascular tone are well-described and relevant to term infants with persistent pulmonary hypertension, the pathophysiology of respiratory failure in preterm infants may be quite different. Chronic lung disease (CLD) represents the final pathway of a heterogeneous group of pulmonary disorders of infancy that usually start in the neonatal period. CLD most commonly occurs in preterm (<30 weeks of gestational age (GA) infants with birth weights less than 1,500 g, and especially in those very preterm (<26 wks GA) with birth weights less than 1,000 g, and who have been treated for respiratory distress syndrome (RDS).

• Drug: Nitric Oxide for inhalation
• Drug: Nitrogen

• Other: 24+0-25+6 days weeks gestational age
• Other: 26+0 - 28+6 days weeks Gestational Age

Inclusion 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 on a mean airway pressure ≥ 4cm H2O) within 24 hours of birth in order to maintain an SpO2 ≥ 85%.
• Informed consent of the guardian.

Exclusion Criteria:

• Outborn infants.
• Infants ≥ 29 weeks gestational age.
• 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 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.