Pulmonary Disease Clinical Trial
Official title:
Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants
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
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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