Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effects of Nitric Oxide for Inhalation on the Development of Chronic Lung Disease in Pre-term Infants
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Weighing between 500 to 1250 grams at birth
* Gestational age of less than 34 weeks
* Less than 48 hours old
* Respiratory failure on mechanical ventilation
* Absence of structural heart disease (PDA, ASD less than 1 cm, or VSD less than 2 mm are permitted if known prior to study entry)
* Absence of lethal congenital anomaly

Exclusion Criteria:

* Concurrent participation in another experimental study (observational studies will be allowed with prior approval by the Steering Committee and Data and Safety Monitoring Board)
* Active pulmonary hemorrhage
* Unevaluated pneumothorax
* High frequency jet ventilation
* Expected short duration of ventilation (less than 48 hours from birth)
B: 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 continuous positive airway pressure (CPAP) (fraction of inspired oxygen concentration (FiO2) ≥ 0.30 on a mean airway pressure ≥ 4cm water (H2O)) within 24 hours of birth in order to maintain an oxygen saturation (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 controlled mechanical ventilation (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 per millimeter cube (mm³), fibrinogen \<0.5 gram per liter (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.
C: Preterm infants who are 500-1250 grams at birth and who require mechanical ventilation at 10 to 21 days of age. Exclusions include congenital heart disease or pulmonary abnormalities, including a patent ductus arteriosus, ventilation solely for apnea, small-for-gestational age, or clinical bleeding.
D: Inclusion Criteria:

* Birth weight of 500-1250 grams and gestational age of less than 34 weeks
* Age at enrollment is less than 72 hours
* Supplemental oxygen or 21% requirement by nasal cannula or NCPAP only

Exclusion Criteria:

* Presence of structural heart disease (other than patent ductus arteriosus, atrial septal defect less than 1 cm, or muscular ventricular septal defect less than 2 mm)
* Presence of lethal congenital anomaly
* Participating in another concurrent experimental study
* Requires mechanical ventilation in the first 72 hours of life (patients are not excluded if they are intubated briefly but they must be extubated at the time of consent and study entry prior to 72 hours of life)

Answer: B