ADINA vs. High Flow Nasal Cannula Comparison Study

N/ANot Yet RecruitingNCT03171129

Loma Linda University40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Respiratory Distress Neonatal

Interventions

Adaptive Dynamic Inspiratory Nasal ApparatusDEVICE

Oxygen will be administered via ADINA

High flow Nasal CanulaDEVICE

Oxygen will be administered via nasal canula

Eligibility

Sex: ALLMin age: 23 WeeksMax age: 40 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

Loma Linda University Medical Center

Loma Linda, California, United States

Outcomes

Primary Outcomes

Duration of Oxygen Use

The length of time the patient is on oxygen will be measured in hours.

Time frame: From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days.

Secondary Outcomes

Oxygen Concentration

ADINA will provide a concentration of oxygen between 1.5 and 4 liters which is equivalent to that provided by the conventional nasal cannula. This will be measured every twelve hours by NICU staff.

Time frame: From time of randomization until time of discharge from NICU up to 100 days.

Number of Participants with treatment-related pneumothorax

Participants will be monitored for pneumothorax occurrence while on ADINA and/or high flow nasal cannula. The incidence of pneumothorax occurrence in each Arm will be collected for comparison.

Time frame: From time of randomization until time of discharge from NICU up to 100 days.

Number of Participants with Excoriation at Nasal Site

Participants will be monitored for excoriation at the nasal site while on ADINA and/or high flow nasal cannula. The incidence of excoriation at the nasal site in each Arm will be collected for comparison.

Time frame: From time of randomization until time of discharge from NICU up to 100 days.

Central Contacts

Tina Ramirez

CONTACT

909-558-5828 TIRameriz@llu.edu

Alyssa Taber

CONTACT

909-558-6087 ATaber@llu.edu

Data from ClinicalTrials.gov

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