Status:
COMPLETED
Study of Nasal Ventilation In Preterm Infants To Decrease Time on The Respirator
Lead Sponsor:
Women and Infants Hospital of Rhode Island
Conditions:
Bronchopulmonary Dysplasia
Eligibility:
All Genders
Up to 48 years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01440647
Start Date
November 1 2007
End Date
January 1 2010
Last Update
March 12 2013
Active Locations (1)
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1
Women and Infants Hospital of RI
Providence, Rhode Island, United States, 02905