Non-invasive Neurally Adjusted Ventilator Assist or Continuous Positive Airway Pressure in Preterm Infants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Premature Birth
- Respiratory Distress Syndrome, Newborn
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Double (Care Provider, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 96 years
- Gender
- Both males and females
Description
This is a randomized cross-over study with AB/BA sequences. The infants will receive both interventions in 4 hours intervals, and a 30 min wash out period to change the breathing support and stabilization at the beginning of both interventions. Initially positive end expiratory pressure are set to 5...
This is a randomized cross-over study with AB/BA sequences. The infants will receive both interventions in 4 hours intervals, and a 30 min wash out period to change the breathing support and stabilization at the beginning of both interventions. Initially positive end expiratory pressure are set to 5 cm H2O and can be adjusted up to 7 cm H2O if needed decided by the medical team for both interventions. The neurally adjusted level will be set to obtain average Edi peak < 15 microvolt. Back-up setting and apnea time in the ventilator assist intervention (NIV NAVA) will be individualized according to clinical parameters in each preterm infant.
Tracking Information
- NCT #
- NCT04333563
- Collaborators
- Norwegian University of Science and Technology
- Investigators
- Study Director: Elisabeth Selvaag, md St Olavs Hospital, Barne- og ungdomsklinikk
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