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

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 Overview

• Status: Unknown
• Conditions: Respiratory Distress Syndrome in Premature Infant
• Intervention / Treatment: Device: Nasal interface

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).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley Lynch, M.D.; Phone Number: 501-412-0988; Email: allynch@uams.edu

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Recruiting
      • Arkansas Children's Hospital
      • Contact: Ashley Lynch, M.D.; Phone Number: 501-412-0988; Email: allynch@uams.edu
      • Principal Investigator: Ashley L Lynch, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: nCPAP prongs	Device: Nasal interface; Randomized to initial interface of nCPAP prongs or infant cannula; Other Names: Neotech RAM infant cannula; Miniflow Nasal CPAP Prongs
Active Comparator: Infant cannula	Device: Nasal interface; Randomized to initial interface of nCPAP prongs or infant cannula; Other Names: Neotech RAM infant cannula; Miniflow Nasal CPAP Prongs

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: non-invasive ventilation; tidal volume; nasal intermittent positive pressure ventilation; nasal continuous positive airway pressure prongs; infant nasal cannula
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: GR037133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No