Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will:

1. decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death

2. shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Collaborators: Children's Hospital of Fudan University; Children's Hospital of Hebei Province; Hunan Children's Hospital; QuanZhou Women and Children's Hospital; Shen-Zhen City Maternity and Child Healthcare Hospital; The First Affiliated Hospital of Xiamen University; Xiamen Women's and Children's Hospital
• Treatments: Endothelium-Dependent Relaxing Factors; Nitric Oxide

Criteria

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