Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia (NO-BPD)
|ClinicalTrials.gov Identifier: NCT01503801|
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : January 28, 2013
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
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease||Drug: Nitric Oxide Device: respiratory support||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants|
|Study Start Date :||May 2011|
|Primary Completion Date :||September 2012|
|Study Completion Date :||December 2012|
Experimental: inhaled nitric oxide
The preterm infants in the experimental group inhaled nitric oxide
Drug: Nitric Oxide
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
Active Comparator: oxygen
The preterm infants enrolled but subjected to routine respiratory support.
Device: respiratory support
Routine respiratory support.
- Death or Bronchopulmonary Dysplasia [ Time Frame: Before discharge or at 36 weeks post-conceptional age ]the incidence of death before discharge or BPD at 36 weeks post-conceptional age
- Intraventricular Hemorrhage Grade III and IV [ Time Frame: At 36 weeks post-conceptional age ]the incidence of Intraventricular Hemorrhage Grade III and IV At 36 weeks post-conceptional age
- Days on assisted ventilation [ Time Frame: Before discharge ]Days on assisted ventilation before discharge
- Length of oxygen therapy [ Time Frame: Before discharge ]Length of oxygen therapy before discharge
- Retinopathy of prematurity [ Time Frame: Before discharge ]Retinopathy of prematurity before discharge
- Cost of hospital and NICU stay [ Time Frame: Before discharge ]Medical cost of hospital and NICU stay
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503801
|Children's Hospital of Fudan University|
|Shanghai, Shanghai, China, 201102|
|Principal Investigator:||Bo Sun, Ph.D||Children's Hospital of Fudan University|