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

Last updated: March 26, 2020
Sponsor: Arkansas Children's Hospital Research Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Respiratory Distress Syndrome (Ards)

Treatment

N/A

Clinical Study ID

NCT04326270
GR037133
  • Ages < 28
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Total Participants: 20
Study Start date:
March 07, 2019
Estimated Completion Date:
June 30, 2020

Study 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).

Connect with a study center

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Active - Recruiting

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