Back to resultsA Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure (BIPAP)
Primary Purpose
Neonatal Respiratory Failure
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Nasal Intermittent Positive Pressure Ventilation (NIPPV)
Bi-Level Positive Airway Pressure (BIPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Respiratory Failure focused on measuring Neonatal Respiratory Failure, Newborn Infant, BiPAP, NIPPV
Eligibility Criteria
Inclusion Criteria:
- Newborn infants with birth weight > 500 gm.
- Gestational age > 24 completed weeks.
- 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.
- No known lethal congenital anomaly or genetic syndromes.
- Signed parental informed consent.
Exclusion Criteria:
- Considered non-viable by clinician (decision not to administer effective therapies)
- Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- Infants known to require surgical treatment
- Abnormalities of the upper and lower airways
- Neuromuscular disorders
- Infants who are > 28 days old and continue to require mechanical ventilation with an endotracheal tube
Sites / Locations
- Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
I=NIPPV
II=BiPAP
Arm Description
This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.
This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
Outcomes
Primary Outcome Measures
the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
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
get the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure
Full Information
NCT ID
NCT01318824
First Posted
February 23, 2011
Last Updated
March 22, 2011
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01318824
Brief Title
A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Acronym
BIPAP
Official Title
A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Unknown status
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Respiratory Failure
Keywords
Neonatal Respiratory Failure, Newborn Infant, BiPAP, NIPPV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
I=NIPPV
Arm Type
Placebo Comparator
Arm Description
This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment.
Arm Title
II=BiPAP
Arm Type
Experimental
Arm Description
This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
Intervention Type
Procedure
Intervention Name(s)
Nasal Intermittent Positive Pressure Ventilation (NIPPV)
Other Intervention Name(s)
Nasal Intermittent Positive Pressure Ventilation
Intervention Description
The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment
Intervention Type
Procedure
Intervention Name(s)
Bi-Level Positive Airway Pressure (BIPAP)
Other Intervention Name(s)
Bi-Level Positive Airway Pressure
Intervention Description
BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
Primary Outcome Measure Information:
Title
the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Description
get 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
Secondary Outcome Measure Information:
Title
the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure
Description
get 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
10. Eligibility
Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Newborn infants with birth weight > 500 gm.
Gestational age > 24 completed weeks.
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.
No known lethal congenital anomaly or genetic syndromes.
Signed parental informed consent.
Exclusion Criteria:
Considered non-viable by clinician (decision not to administer effective therapies)
Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
Infants known to require surgical treatment
Abnormalities of the upper and lower airways
Neuromuscular disorders
Infants who are > 28 days old and continue to require mechanical ventilation with an endotracheal tube
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Shi, MD
Organizational Affiliation
Department of Pediatrics, Daping Hospital, Third Military Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shifang Tang
Organizational Affiliation
Department of Pediatrics, Daping Hospital, Third Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
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