Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bronchopulmonary Dysplasia
  • Mechanical Ventilation
  • Neurally Adjusted Ventilatory Assist
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: Prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilationMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 24 years
Gender
Both males and females

Description

Most research to date in neonatal lung disease has focused on bronchopulmonary dysplasia (BPD) prevention. As a result, insufficient investigation has been performed to define optimal respiratory management strategies for infants and young children with established BPD. Thus, there is no robust evid...

Most research to date in neonatal lung disease has focused on bronchopulmonary dysplasia (BPD) prevention. As a result, insufficient investigation has been performed to define optimal respiratory management strategies for infants and young children with established BPD. Thus, there is no robust evidence base to guide ventilator management to promote lung disease recovery and support neurodevelopment in this population. Neurally adjusted ventilatory assist (NAVA) is an alternative to conventional flow triggered ventilation that has shown promise for improving respiratory gas exchange, patient-ventilator interaction, and work of breathing in preterm neonates. The safety and efficacy of NAVA in infants and young children with established, severe BPD is uncertain. This prospective, unblinded, pilot randomized cross-over trial of 2 modes of mechanical ventilation will compare measures of pulmonary mechanics, respiratory gas exchange, and patient comfort between conventional flow triggered mechanical ventilation and NAVA among 20 prematurely born infants and young children receiving invasive respiratory support for severe BPD.

Tracking Information

NCT #
NCT04821453
Collaborators
  • Rhode Island Hospital
  • Children's Miracle Network
Investigators
Principal Investigator: Erik Jensen, MD, MSCE Children's Hospital of Philadelphia