Clinical trial NCT04326270: Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
Official title: Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome in Premature Infant
Keywords: nasal intermittent positive pressure ventilation
non-invasive ventilation
nasal continuous positive airway pressure prongs
infant nasal cannula
tidal volume
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 20
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Relative tidal volume delivery, breath type I
timeFrame: 1 hour
measure: Relative tidal volume delivery, breath type II
timeFrame: 1 hour
measure: Relative tidal volume delivery, breath type III
timeFrame: 1 hour
Secondary outcomes:
measure: Ventilator pressure delivery
timeFrame: 1 hour
measure: Ventilator flow delivery
timeFrame: 1 hour
measure: Heart rate
timeFrame: 1 hour
measure: Oxygen saturation
timeFrame: 1 hour
measure: Transcutaneous carbon dioxide tension
timeFrame: 1 hour
measure: Transcutaneous oxygen tension
timeFrame: 1 hour
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
References: