Back to resultsStudy of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Primary Purpose
Bronchopulmonary Dysplasia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Extubation to NIPPV
Extubation to CPAP
Sponsored by
About this trial
This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring Respiration, Artificial, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure, Non-Invasive Positive-Pressure Ventilation, Intermittent Positive-Pressure Ventilation, High-Frequency Ventilation
Eligibility Criteria
Inclusion Criteria:
- Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria.
- Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life.
- Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz.
- Infants who have never been previously extubated.
Exclusion Criteria:
- Infants enrolled in competing trials.
- Participation refused by parent/attending physician/ parent unavailable for consent.
- Infants with any major congenital abnormality.
- Postoperative patients from any surgery.
- Infants in extremis/decided upon not to receive intensive care.
- Ventilator settings lower than the intervention group.
Sites / Locations
- Women and Infants Hospital of RI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
NIPPV
CPAP
Arm Description
Extubation to NIPPV (nasal intermittent positive pressure ventilation)
After extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life
Outcomes
Primary Outcome Measures
Number of Days Being Intubated
Secondary Outcome Measures
Percentage of Participants With Reintubation
Reintubation rate is a measure of the efficacy of NIPPV.
Full Information
NCT ID
NCT01440647
First Posted
September 22, 2011
Last Updated
February 7, 2013
Sponsor
Women and Infants Hospital of Rhode Island
1. Study Identification
Unique Protocol Identification Number
NCT01440647
Brief Title
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Official Title
Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Women and Infants Hospital of Rhode Island
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Very premature infants often cannot breathe on their own and require assistance with a respirator. Conventional respirators deliver air or oxygen via a breathing tube placed through the mouth to the airway (endotracheal tube). A prolonged use of an endotracheal tube is associated with injury to the lungs. Currently, a premature baby has to be ventilated through an endotracheal tube until he/she can fully breathe independently. In the current study, in order to shorten the time with an endotracheal tube, we utilized an alternative, less invasive ventilation procedure, nasal intermittent positive pressure ventilation (NIPPV). This procedure provides help with breathing, but requires only nasal, not endotracheal tubes. We hypothesized that NIPPV might help babies breathe, at an early stage in their recovery, when they could not breathe independently yet. Thus, by switching babies at this early stage from a regular respirator to NIPPV, we should be able to shorten the use of an injurious endotracheal tube.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Respiration, Artificial, Infant, Premature, Bronchopulmonary Dysplasia, Continuous Positive Airway Pressure, Non-Invasive Positive-Pressure Ventilation, Intermittent Positive-Pressure Ventilation, High-Frequency Ventilation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIPPV
Arm Type
Experimental
Arm Description
Extubation to NIPPV (nasal intermittent positive pressure ventilation)
Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
After extubation this arm was placed on CPAP (continuous positive airway pressure) and was not offered NIPPV in the first month on life
Intervention Type
Procedure
Intervention Name(s)
Extubation to NIPPV
Other Intervention Name(s)
NIPPV
Intervention Description
After extubation infants were placed on NIPPV as soon as all the extubation criteria were met
Intervention Type
Procedure
Intervention Name(s)
Extubation to CPAP
Other Intervention Name(s)
CPAP
Intervention Description
After extubation infants were placed on CPAP
Primary Outcome Measure Information:
Title
Number of Days Being Intubated
Time Frame
30 days from birth
Secondary Outcome Measure Information:
Title
Percentage of Participants With Reintubation
Description
Reintubation rate is a measure of the efficacy of NIPPV.
Time Frame
0-7 days post-extubation
10. Eligibility
Sex
All
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational age 24 wks and 0 days through 27 wks and 6 days by obstetric criteria.
Infants who are intubated for respiratory distress and received surfactant within 48 hrs of life.
Infants whose ventilator settings are: ventilatory rate ≥ 26 breaths per minute. If the baby is on the high frequency oscillatory ventilator (HFOV) settings are MAP(mean airway pressure) ≥ 9, amplitude ≥ 2xMAP and frequency ≤ 13 Hertz.
Infants who have never been previously extubated.
Exclusion Criteria:
Infants enrolled in competing trials.
Participation refused by parent/attending physician/ parent unavailable for consent.
Infants with any major congenital abnormality.
Postoperative patients from any surgery.
Infants in extremis/decided upon not to receive intensive care.
Ventilator settings lower than the intervention group.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga A DeSimone, MD
Organizational Affiliation
The Floating Hospital for Children at Tufts Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Abbot R Laptook, MD
Organizational Affiliation
Women and Infants Hospital of RI
Official's Role
Study Director
Facility Information:
Facility Name
Women and Infants Hospital of RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
12. IPD Sharing Statement
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Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
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