Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia (NO-BPD)

Children's Hospital of Fudan University, Children's Hospital of Hebei Province, Shen-Zhen City Maternity and Child Healthcare Hospital, Hunan Children's Hospital, QuanZhou Women and Children's Hospital, The First Affiliated Hospital of Xiamen University, Xiamen Women's and Children's Hospital

Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will: decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect

Bronchopulmonary dysplasia remains a problem in neonatal intensive care unit (NICU) all over the world. This multicenter, non-randomized, unmasked clinical trial evaluate the efficacy of inhaled nitric oxide (iNO) in the treatment of the preterm infant with developing bronchopulmonary dysplasia. Infants were followed until death or discharge to home. The trial will compare iNO therapy to conventional management strategies (including treatment with nasal continuous positive airway pressure (CPAP), surfactant and high frequency ventilation as adjuncts to iNO therapy) as the control. During the initial dosing, iNO was started at 5 ppm and could be decreased to 1-2 ppm. The Infants would inhale NO until weaned. Infants will be monitored for signs of toxicity due to cumulated dosage of NO and its metabolites, such as methemoglobin, and nitrite and nitrate in blood and urine, and nitrogen dioxide in ventilator circuit to the patient.

Preterm neonates, Bronchopulmonary dysplasia, Chronic lung disease, Inhaled nitric oxide, Respiratory therapy

The infants in experimental group will receive inhale nitric oxide initiated at 5 ppm for 24 h followed by 2 ppm for 6 days or until weaning off

Inclusion Criteria: GA<=34w,less than 7 days of age,oxygenation index (OI) of more than 10 after being ventilated for more than 48 hours or surfactant therapy GA<=34w,between 7 to 30 days of age, requiring assisted ventilator or nasal continuous positive airway pressure for more than 2 days Exclusion Criteria: lethal congenital anomalies or congenital heart disease (including an atrial septal defect larger than 1 cm and a ventricular septal defect larger than 2 mm) active pulmonary hemorrhage, unevaluated pneumothorax preexisting bilateral grade 3-4 intraventricular hemorrhage a platelet count <100*10^9/l an expected duration of ventilation of less than 48 hours