ADINA vs. High Flow Nasal Cannula Comparison Study

Not Applicable

Not yet recruiting

• Conditions: Respiratory Distress Neonatal

• Registration Number: NCT03171129
• Lead Sponsor: Loma Linda University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-05-26
• Study First Posted: 2017-05-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-03
• Study Start: 2025-09
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Duration of Oxygen Use	From time of randomization until time of discharge from the Neonatal Intensive Care Unit (NICU) up to 100 days.	The length of time the patient is on oxygen will be measured in hours.

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Excoriation at Nasal Site	From time of randomization until time of discharge from NICU up to 100 days.	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.
Oxygen Concentration	From time of randomization until time of discharge from NICU up to 100 days.	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.
Number of Participants with treatment-related pneumothorax	From time of randomization until time of discharge from NICU up to 100 days.	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.

Trial Locations

Locations (1)

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States