Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia (NO-BPD)

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease
• Intervention / Treatment: Drug: Nitric Oxide; Device: respiratory support

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 month (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: inhaled nitric oxide; The preterm infants in the experimental group inhaled nitric oxide	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)
ACTIVE_COMPARATOR: oxygen; The preterm infants enrolled but subjected to routine respiratory support.	Device: respiratory support; Routine respiratory support.; Other Names: Nasal CPAP; Conventional mechanical ventilation; High frequency Oscillatory ventilation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Children's Hospital of Fudan University; Hunan Children's Hospital; The First Affiliated Hospital of Xiamen University; Shen-Zhen City Maternity and Child Healthcare Hospital; Children's Hospital of Hebei Province; QuanZhou Women and Children's Hospital; Xiamen Women's and Children's Hospital
• Investigators: Principal Investigator: Bo Sun, Ph.D, Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: January 3, 2012
• First Posted (ESTIMATE): January 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2013
• Last Update Submitted That Met QC Criteria: January 24, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Bronchopulmonary dysplasia; Chronic lung disease; Respiratory therapy; Preterm neonates; Inhaled nitric oxide
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Gasotransmitters; Nitric Oxide; Endothelium-Dependent Relaxing Factors
• Other Study ID Numbers: FudanU