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

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ClinicalTrials.gov Identifier: NCT01318824
Recruitment Status : Unknown
Verified January 2011 by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University.
Recruitment status was:  Active, not recruiting
First Posted : March 21, 2011
Last Update Posted : March 23, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.

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

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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
Study Start Date : December 2010
Primary Completion Date : January 2011
Estimated Study Completion Date : February 2013

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    get the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure


Secondary Outcome Measures :
  1. 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 ]
    get the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure


Eligibility Criteria

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: January 2011

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