Overview

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