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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01503801
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : January 28, 2013
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Pulmonary Disease Drug: Nitric Oxide Device: respiratory support Phase 2 Phase 3

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants
Study Start Date : May 2011
Primary Completion Date : September 2012
Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. Death or Bronchopulmonary Dysplasia [ Time Frame: 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 :
  1. Intraventricular Hemorrhage Grade III and IV [ Time Frame: At 36 weeks post-conceptional age ]
    the incidence of Intraventricular Hemorrhage Grade III and IV At 36 weeks post-conceptional age

  2. Days on assisted ventilation [ Time Frame: Before discharge ]
    Days on assisted ventilation before discharge

  3. Length of oxygen therapy [ Time Frame: Before discharge ]
    Length of oxygen therapy before discharge

  4. Retinopathy of prematurity [ Time Frame: Before discharge ]
    Retinopathy of prematurity before discharge

  5. Cost of hospital and NICU stay [ Time Frame: Before discharge ]
    Medical cost of hospital and NICU stay

Eligibility Criteria

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503801

China, Shanghai
Children's Hospital of Fudan University
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Fudan University
Children's Hospital of Fudan University
Children's Hospital of Hebei Province
Shen-Zhen City Maternity and Child Healthcare Hospital
Hunan Children's Hospital
QuanZhou Women and Children's Hospital
The First Affiliated Hospital of Xiamen University
Xiamen Women's and Children's Hospital
Principal Investigator: Bo Sun, Ph.D Children's Hospital of Fudan University
More Information

Responsible Party: Bo Sun, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT01503801     History of Changes
Other Study ID Numbers: FudanU
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

Keywords provided by Bo Sun, Fudan University:
Preterm neonates
Bronchopulmonary dysplasia
Chronic lung disease
Inhaled nitric oxide
Respiratory therapy

Additional relevant MeSH terms:
Nitric Oxide
Lung Diseases
Bronchopulmonary Dysplasia
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases
Endothelium-Dependent Relaxing Factors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Vasodilator Agents
Protective Agents