Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

Phase 2

Completed

• Conditions: Pulmonary Disease
• Interventions: Drug: Nitric Oxide; Device: respiratory support

• Registration Number: NCT01503801
• Lead Sponsor: Fudan University

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 therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect

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 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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-12-19
• Study First Submitted QC: 2012-01-03
• Study First Posted: 2012-01-04
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-24
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
inhaled nitric oxide	Nitric Oxide	The preterm infants in the experimental group inhaled nitric oxide
oxygen	respiratory support	The preterm infants enrolled but subjected to routine respiratory support.

Primary Outcome Measures

Name	Time	Method
Death or Bronchopulmonary Dysplasia	Before discharge or at 36 weeks post-conceptional age	the incidence of death before discharge or BPD at 36 weeks post-conceptional age

Secondary Outcome Measures

Name	Time	Method
Intraventricular Hemorrhage Grade III and IV	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	Before discharge	Days on assisted ventilation before discharge
Length of oxygen therapy	Before discharge	Length of oxygen therapy before discharge
Retinopathy of prematurity	Before discharge	Retinopathy of prematurity before discharge
Cost of hospital and NICU stay	Before discharge	Medical cost of hospital and NICU stay

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China