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
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.
Study Type
Interventional
Primary Outcome
Number of Days Being Intubated
Secondary Outcome
Percentage of Participants With Reintubation
Condition
Bronchopulmonary Dysplasia
Intervention
Extubation to NIPPV
Study Arms / Comparison Groups
NIPPV
Description: Extubation to NIPPV (nasal intermittent positive pressure ventilation)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
34
Start Date
November 2007
Completion Date
January 2010
Primary Completion Date
July 2009
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.
Gender
All
Ages
N/A - 48 Hours
Accepts Healthy Volunteers
No
Contacts
Olga A DeSimone, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01440647
Organization ID
07-0090
Responsible Party
Principal Investigator
Study Sponsor
Women and Infants Hospital of Rhode Island
Study Sponsor
Olga A DeSimone, MD, Principal Investigator, The Floating Hospital for Children at Tufts Medical Center
Verification Date
February 2013