Status:
COMPLETED
Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA
Lead Sponsor:
University of Florida
Conditions:
Preterm Infant
BPD - Bronchopulmonary Dysplasia
Eligibility:
All Genders
24-32 years
Phase:
NA
Brief Summary
Extubation failure is a significant problem in preterm neonates and prolonged intubation is a well-documented risk factor for development of chronic lung disease. Out of the respiratory modalities ava...
Detailed Description
Mechanical ventilation is needed for most preterm infants to maintain adequate oxygenation and ventilation. However the coexistence of lung immaturity, weak respiratory drive, excessively compliant ch...
Eligibility Criteria
Inclusion
- Infants born between 24 weeks and ≤ 32 weeks completed gestational age or birth weight less than or equal to 1500 grams
- Postnatal age ≤ 14 days
- Inborn
- Mechanically ventilated for at least 12 hrs.
- Intubated within first 24 hrs. after birth
- Outborn infants intubated and transferred to UF within 24 hrs. after birth.
Exclusion
- Outborn \> 24hrs of age.
- Failed elective extubation prior to study enrollment
- Major congenital anomalies or known/suspected chromosomal anomalies
- Use of paralytics in previous 24 hrs.
- Participation in another randomized interventional trial
- Known or suspected phrenic nerve palsy or lesion
- Known or suspected diaphragmatic lesion
- Any contraindication to have a nasogastric or orogastric tube placement
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03242057
Start Date
October 23 2017
End Date
September 5 2019
Last Update
February 19 2020
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32207