Status:
COMPLETED
Neural Control of Non-invasive Ventilation in the Preterm
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Respiratory Distress Syndrome, Newborn
Infant, Premature
Eligibility:
All Genders
1-6 years
Phase:
PHASE1
Brief Summary
The present study will use a new type of respirator in premature babies who need help with their breathing. This new respirator uses signals from the baby's diaphragm - the most important breathing mu...
Detailed Description
There is an abundance of evidence in the literature suggesting that maintenance of spontaneous breathing with a synchronized mode of ventilatory assist, and the use of non-invasive interface to delive...
Eligibility Criteria
Inclusion
- Part 1: Preterm newborns (\>1 week postnatal age, gestational age\> 23 weeks, birth weight \<1000g), intubated and mechanically ventilated, and breathing spontaneously. Infants should be breathing on a triggered mode of ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: assist control/pressure support \< 20 cm H2O, PEEP4-7 cm H2O, SIMV rate\< 30, FIO2\<40%/.
- Part 2:Newborns recovering from respiratory illness and deemed to be ready for elective extubation by their attending physician, intubated and mechanically ventilated, and breathing spontaneously.
Exclusion
- Protocols 1 and 2: Pneumothorax, degenerative neuromuscular disease, bleeding disorders, cardiovascular instability (defined as hypotension or need for treatment with volume expansion or inotropes in the previous 24 hours), cyanotic congenital cardiovascular disease, treatment with narcotics, phrenic nerve damage/diaphragm paralysis, esophageal perforation, use of high frequency oscillatory ventilation
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00368485
Start Date
August 1 2006
End Date
June 1 2008
Last Update
September 21 2011
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M5S1B6