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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Page 1 of 1 (1 locations)

1

University of Florida

Jacksonville, Florida, United States, 32207

Comparison of Primary Extubation Failure Between NIPPV and NI-NAVA | DecenTrialz