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

Not Applicable

• Conditions: Respiratory Distress Syndrome in Premature Infant
• Interventions: Device: Nasal interface

• Registration Number: NCT04326270
• Lead Sponsor: Arkansas Children's Hospital Research Institute

Brief Summary

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.

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 Timeline

• Study Start: 2019-03-07
• Status Verified: 2020-03
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-26
• Study First Posted: 2020-03-30
• Last Update Posted: 2020-03-30
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
nCPAP prongs	Nasal interface	-
Infant cannula	Nasal interface	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States