A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01318824
First received: February 23, 2011
Last updated: March 22, 2011
Last verified: January 2011
  Purpose

To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.


Condition Intervention Phase
Neonatal Respiratory Failure
Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)
Procedure: Bi-Level Positive Airway Pressure (BIPAP)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:

Primary Outcome Measures:
  • the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure [ Time Frame: At 7 days, 28 days and at 36 weeks postmenstraul age ] [ Designated as safety issue: Yes ]
    get the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure


Secondary Outcome Measures:
  • the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure [ Time Frame: At 7 days, 28 days and at 36 weeks postmenstraul age ] [ Designated as safety issue: Yes ]
    get the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure


Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: February 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: I=NIPPV
This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.
Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)
The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment
Other Name: Nasal Intermittent Positive Pressure Ventilation
Experimental: II=BiPAP
This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
Procedure: Bi-Level Positive Airway Pressure (BIPAP)
BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
Other Name: Bi-Level Positive Airway Pressure

Detailed Description:

Bi-Level Positive Airway Pressure(BiPAP) is similar to Non Invasive Positive Pressure Ventilation (NIPPV), but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. BiPAP is safe and effective. Nevertheless, BiPAP has never been used in Chinese babies.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Newborn infants with birth weight > 500 gm.
  2. Gestational age > 24 completed weeks.
  3. Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
  4. No known lethal congenital anomaly or genetic syndromes.
  5. Signed parental informed consent.

Exclusion Criteria:

  1. Considered non-viable by clinician (decision not to administer effective therapies)
  2. Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
  3. Infants known to require surgical treatment
  4. Abnormalities of the upper and lower airways
  5. Neuromuscular disorders
  6. Infants who are > 28 days old and continue to require mechanical ventilation with an endotracheal tube
  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: NCT01318824

Locations
China, Chongqing
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Investigators
Study Director: Yuan Shi, MD Department of Pediatrics, Daping Hospital, Third Military Medical University
Principal Investigator: Shifang Tang Department of Pediatrics, Daping Hospital, Third Military Medical University
  More Information

No publications provided

Responsible Party: Yuan Shi and Shifang Tang, Daping Hospital, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01318824     History of Changes
Other Study ID Numbers: 2011002
Study First Received: February 23, 2011
Last Updated: March 22, 2011
Health Authority: United States: Food and Drug Administration
China: Ministry of Health

Keywords provided by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University:
Neonatal Respiratory Failure
Newborn Infant
BiPAP
NIPPV

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 01, 2014