Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

NCT ID: NCT01503801

Last Updated: 2013-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-12-31

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

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.

Conditions

Pulmonary Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

inhaled nitric oxide

The preterm infants in the experimental group inhaled nitric oxide

Group Type: EXPERIMENTAL

Nitric Oxide

Intervention Type: 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

oxygen

The preterm infants enrolled but subjected to routine respiratory support.

Group Type: ACTIVE_COMPARATOR

respiratory support

Intervention Type: DEVICE

Routine respiratory support.

Interventions

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

Intervention Type: DRUG

respiratory support

Routine respiratory support.

Intervention Type: DEVICE

Other Intervention Names

Nitrogen Monoxide; Endothelium Derived Relaxing Factor (EDRF); Nasal CPAP; Conventional mechanical ventilation; High frequency Oscillatory ventilation

Eligibility 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

• Minimum Eligible Age: 1 Hour
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: collaborator

Children's Hospital of Hebei Province

OTHER

Sponsor Role: collaborator

Shen-Zhen City Maternity and Child Healthcare Hospital

OTHER

Sponsor Role: collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role: collaborator

QuanZhou Women and Children's Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: collaborator

Xiamen Women's and Children's Hospital

UNKNOWN

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Bo Sun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bo Sun, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FudanU

Identifier Type: -

Identifier Source: org_study_id