Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
Children's Hospital of Fudan University
Hebei Provincial Children's Hospital
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
Information provided by (Responsible Party):
Bo Sun, Fudan University
ClinicalTrials.gov Identifier:
NCT01503801
First received: December 19, 2011
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Pulmonary Disease
Drug: Nitric Oxide
Device: respiratory support
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia in Preterm Infants

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Death or Bronchopulmonary Dysplasia [ Time Frame: Before discharge or at 36 weeks post-conceptional age ] [ Designated as safety issue: Yes ]
    the incidence of death before discharge or BPD at 36 weeks post-conceptional age


Secondary Outcome Measures:
  • Intraventricular Hemorrhage Grade III and IV [ Time Frame: At 36 weeks post-conceptional age ] [ Designated as safety issue: Yes ]
    the incidence of Intraventricular Hemorrhage Grade III and IV At 36 weeks post-conceptional age

  • Days on assisted ventilation [ Time Frame: Before discharge ] [ Designated as safety issue: No ]
    Days on assisted ventilation before discharge

  • Length of oxygen therapy [ Time Frame: Before discharge ] [ Designated as safety issue: No ]
    Length of oxygen therapy before discharge

  • Retinopathy of prematurity [ Time Frame: Before discharge ] [ Designated as safety issue: Yes ]
    Retinopathy of prematurity before discharge

  • Cost of hospital and NICU stay [ Time Frame: Before discharge ] [ Designated as safety issue: No ]
    Medical cost of hospital and NICU stay


Enrollment: 400
Study Start Date: May 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 30 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503801

Locations
China, Shanghai
Children's Hospital of Fudan University
Shanghai, Shanghai, China, 201102
Sponsors and Collaborators
Fudan University
Children's Hospital of Fudan University
Hebei Provincial Children's Hospital
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
Investigators
Principal Investigator: Bo Sun, Ph.D Children's Hospital of Fudan University
  More Information

No publications provided

Responsible Party: Bo Sun, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT01503801     History of Changes
Other Study ID Numbers: FudanU
Study First Received: December 19, 2011
Last Updated: January 24, 2013
Health Authority: China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on November 23, 2014