Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs

Overview

Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2020

Detailed Description

Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).

Interventions

  • Device: Nasal interface
    • Randomized to initial interface of nCPAP prongs or infant cannula

Arms, Groups and Cohorts

  • Active Comparator: nCPAP prongs
  • Active Comparator: Infant cannula

Clinical Trial Outcome Measures

Primary Measures

  • Relative tidal volume delivery, breath type I
    • Time Frame: 1 hour
    • Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths
  • Relative tidal volume delivery, breath type II
    • Time Frame: 1 hour
    • Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths
  • Relative tidal volume delivery, breath type III
    • Time Frame: 1 hour
    • Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths

Secondary Measures

  • Ventilator pressure delivery
    • Time Frame: 1 hour
  • Ventilator flow delivery
    • Time Frame: 1 hour
  • Heart rate
    • Time Frame: 1 hour
  • Oxygen saturation
    • Time Frame: 1 hour
  • Transcutaneous carbon dioxide tension
    • Time Frame: 1 hour
  • Transcutaneous oxygen tension
    • Time Frame: 1 hour

Participating in This Clinical Trial

Inclusion Criteria

  • Chronologic age less than 28 days
  • Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days
  • Currently receiving NIPPV, NIV NAVA, or nCPAP

Exclusion Criteria

  • Oxygen requirement greater than 40%
  • Peak inspiratory pressure greater than 20 cm H2O
  • Major congenital anomalies of the heart or lungs

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 28 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Arkansas Children’s Hospital Research Institute
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ashley L. Lynch, Principle Investigator – Arkansas Children’s Hospital Research Institute
  • Overall Contact(s)
    • Ashley Lynch, M.D., 501-412-0988, allynch@uams.edu

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