Status:
COMPLETED
Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Children's Hospital of Fudan University
Children's Hospital of Hebei Province
Conditions:
Pulmonary Disease
Eligibility:
All Genders
1-30 years
Phase:
PHASE2
PHASE3
Brief 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 t...
Detailed Description
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 nitri...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT01503801
Start Date
May 1 2011
End Date
December 1 2012
Last Update
January 28 2013
Active Locations (1)
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1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102