Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

NCT01503801 | Completed Phase 2 DMC

• 1 other identifier: FudanU
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Inhaled nitric oxide in preterm babies with respiratory failure or ventilator dependence will:

1. 1.decrease the incidence of Bronchopulmonary Dysplasia (BPD) or death
2. 2.shorten the length of oxygen therapy and hospital stay ,reduce the cost of hospital stay without increasing adverse effect

Conditions

Pulmonary Disease

Keywords

Preterm neonates; Bronchopulmonary dysplasia; Chronic lung disease; Inhaled nitric oxide; Respiratory therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intraventricular Hemorrhage Grade III and IV

  At 36 weeks post-conceptional age

• Days on assisted ventilation

  Before discharge

• Length of oxygen therapy

  Before discharge

• Retinopathy of prematurity

  Before discharge

• Cost of hospital and NICU stay

  Before discharge

Study Arms (2)

inhaled nitric oxide

EXPERIMENTAL

The preterm infants in the experimental group inhaled nitric oxide

Drug: Nitric Oxide

oxygen

ACTIVE COMPARATOR

The preterm infants enrolled but subjected to routine respiratory support.

Device: respiratory support

Interventions

Nitric Oxide DRUG

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

Also known as: Nitrogen Monoxide, Endothelium Derived Relaxing Factor (EDRF)

inhaled nitric oxide

respiratory support DEVICE

Routine respiratory support.

Also known as: Nasal CPAP, Conventional mechanical ventilation, High frequency Oscillatory ventilation

oxygen

Eligibility Criteria

• Age: 1 Hour - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead
• Children's Hospital of Fudan University: collaborator
• Children's Hospital of Hebei Province: collaborator
• Shen-Zhen City Maternity and Child Healthcare Hospital: collaborator
• Hunan Children's Hospital: collaborator
• QuanZhou Women and Children's Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Xiamen Women's and Children's Hospital: collaborator

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Lung Diseases; Bronchopulmonary Dysplasia

Interventions

Nitric Oxide; Endothelium-Dependent Relaxing Factors

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals; Vasodilator Agents; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Bo Sun, Ph.D

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: January 4, 2012
• Study Start: May 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

CN (1)