Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

Fudan University400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

400

Conditions

Pulmonary Disease

Interventions

Nitric OxideDRUG

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

respiratory supportDEVICE

Routine respiratory support.

Eligibility

Sex: ALLMin age: 1 HourMax age: 30 Days

Medical Language ↔ Plain English

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

Locations (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Death or Bronchopulmonary Dysplasia

the incidence of death before discharge or BPD at 36 weeks post-conceptional age

Time frame: Before discharge or at 36 weeks post-conceptional age

Secondary Outcomes

Intraventricular Hemorrhage Grade III and IV

the incidence of Intraventricular Hemorrhage Grade III and IV At 36 weeks post-conceptional age

Time frame: At 36 weeks post-conceptional age

Days on assisted ventilation

Days on assisted ventilation before discharge

Time frame: Before discharge

Length of oxygen therapy

Length of oxygen therapy before discharge

Time frame: Before discharge

Retinopathy of prematurity

Retinopathy of prematurity before discharge

Time frame: Before discharge

Cost of hospital and NICU stay

Medical cost of hospital and NICU stay

Time frame: Before discharge

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.