Trial | NCT01503801  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    nitric oxide ...

  • Study Participants

    400
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
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 Started
May 31
2011
Primary Completion
Sep 30
2012
Study Completion
Dec 31
2012
Last Update
Jan 28
2013
Estimate

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

  • Other names: Nitrogen Monoxide, Endothelium Derived Relaxing Factor (EDRF)

Device respiratory support

Routine respiratory support.

  • Other names: Nasal CPAP, Conventional mechanical ventilation, High frequency Oscillatory ventilation

inhaled nitric oxide Experimental

The preterm infants in the experimental group inhaled nitric oxide

oxygen Active Comparator

The preterm infants enrolled but subjected to routine respiratory support.

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
No Results Posted