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Clinical Trials/NCT01440647
NCT01440647
Completed
Not Applicable

Nasal Intermittent Positive Pressure Ventilation Allows Early Extubation In Infants Less Than 28 Weeks Gestation: A Pilot Study

Women and Infants Hospital of Rhode Island1 site in 1 country34 target enrollmentNovember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bronchopulmonary Dysplasia
Sponsor
Women and Infants Hospital of Rhode Island
Enrollment
34
Locations
1
Primary Endpoint
Number of Days Being Intubated
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
January 2010
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Women and Infants Hospital of Rhode Island
Responsible Party
Principal Investigator
Principal Investigator

Olga Sorina

Principal Investigator

Women and Infants Hospital of Rhode Island

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.

Outcomes

Primary Outcomes

Number of Days Being Intubated

Time Frame: 30 days from birth

Secondary Outcomes

  • Percentage of Participants With Reintubation(0-7 days post-extubation)

Study Sites (1)

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