ADINA vs. High Flow Nasal Cannula Comparison Study

Loma Linda University (LLU)

Status: Begins enrollment in 2 months

Conditions: Respiratory Distress Neonatal

Treatments: Device: High flow Nasal Canula; Device: Adaptive Dynamic Inspiratory Nasal Apparatus

Study type: Interventional

Funder types: Other

Identifiers

NCT03171129

5160055

Details and patient eligibility

About

This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.

Full description

NCPAP has been used increasingly to manage respiratory distress in newborns as well as apnea of prematurity. Humidified high flow nasal cannula devices (flows 1-8 lpm) have also been used in neonatal intensive care units.

This study is to evaluate the feasibility of using a pressure limited nasal cannula system instead of a high flow nasal cannula system in the management of premature babies with respiratory distress.

Enrollment: 40 estimated patients

Sex: All

Ages: 23 to 40 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Neonates admitted to NICU
• Weights of 400-500 grams
• Requiring oxygen greater than 30%
• No evidence of focal lobar consolidation in lung fields

Exclusion criteria

• Intolerance to procedure
• gelatinous skin
• known allergy to adhesive material
• interference with therapy
• profound sepsis
• pneumonia
• unmanaged apnea/bradycardia
• known or suspect complex congenital heart disease
• severe cleft lip or palate
• suspect or proven lethal congenital anomaly
• intolerance to the interface used in the devices
• inability to secure an appropriate fit of the patient nasal interface
• considered non-viable or of uncertain viability
• parental refusal.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

High flow nasal cannula system w/ ADINA

Experimental group

Description:

The intervention is the insertion of the the ADINA device into the high flow nasal cannula system. ADINA will be placed according to weight class recommendations to increase the positive end expiratory pressure (PEEP). ADINA is actually a combination of the Neotech RAM Cannula and a clear Regulator/Pop off valve.

Treatment:

Device: Adaptive Dynamic Inspiratory Nasal Apparatus

high flow nasal cannula system

Active Comparator group

Description:

High flow nasal cannula will deliver oxygen at 2-4 lpm of flow. High flow cannula are used to provide the control interface.

Treatment:

Device: High flow Nasal Canula