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Inhaled Nitric Oxide to Prevent and Treat Bronchopulmonary Dysplasia

NCT01503801 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2013-01-28

No results posted yet for this study

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

Conditions

  • Pulmonary Disease

Interventions

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

DEVICE

respiratory support

Routine respiratory support.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    collaborator OTHER

  • Children's Hospital of Hebei Province

    collaborator OTHER

  • Shen-Zhen City Maternity and Child Healthcare Hospital

    collaborator OTHER

  • Hunan Children's Hospital

    collaborator OTHER_GOV

  • QuanZhou Women and Children's Hospital

    collaborator OTHER

  • The First Affiliated Hospital of Xiamen University

    collaborator OTHER

  • Xiamen Women's and Children's Hospital

    collaborator UNKNOWN

  • Fudan University

    lead OTHER

Principal Investigators

  • Bo Sun, Ph.D · Children's Hospital of Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01503801 on ClinicalTrials.gov