Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants

Conditions
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Pulmonary Disease

Intervention / Treatment
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* Drug: Nitric Oxide
* Device: respiratory support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 30 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inhaled nitric oxide<br>The preterm infants in the experimental group inhaled nitric oxide | Drug: Nitric Oxide<br>* 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<br>* Other names: Endothelium Derived Relaxing Factor (EDRF);|
| Active Comparator: oxygen<br>The preterm infants enrolled but subjected to routine respiratory support. | Device: respiratory support<br>* Routine respiratory support.<br>* Other names: High frequency Oscillatory ventilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death or Bronchopulmonary Dysplasia | the incidence of death before discharge or BPD at 36 weeks post-conceptional age | Before discharge or at 36 weeks post-conceptional age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraventricular Hemorrhage Grade III and IV | the incidence of Intraventricular Hemorrhage Grade III and IV At 36 weeks post-conceptional age | At 36 weeks post-conceptional age | 
| Days on assisted ventilation | Days on assisted ventilation before discharge | Before discharge | 
| Length of oxygen therapy | Length of oxygen therapy before discharge | Before discharge | 
| Retinopathy of prematurity | Retinopathy of prematurity before discharge | Before discharge | 
| Cost of hospital and NICU stay | Medical cost of hospital and NICU stay | Before discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm neonates, Bronchopulmonary dysplasia, Chronic lung disease, Inhaled nitric oxide, Respiratory therapy