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

Respiratory Distress Syndrome in Premature Infant Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04326270
• Other study ID #: GR037133
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2020
• Source: Arkansas Children's Hospital Research Institute
• Contact: Ashley Lynch, M.D.
• Phone: 501-412-0988
• Email: allynch[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
United States	Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative tidal volume delivery, breath type I	Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths	1 hour
Primary	Relative tidal volume delivery, breath type II	Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths	1 hour
Primary	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	Ventilator pressure delivery		1 hour
Secondary	Ventilator flow delivery		1 hour
Secondary	Heart rate		1 hour
Secondary	Oxygen saturation		1 hour
Secondary	Transcutaneous carbon dioxide tension		1 hour
Secondary	Transcutaneous oxygen tension		1 hour