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NCT03171129 | NOT YET RECRUITING | Respiratory Distress Neonatal


ADINA vs. High Flow Nasal Cannula Comparison Study
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.

Condition or disease

Respiratory Distress Neonatal

Intervention/treatment

Adaptive Dynamic Inspiratory Nasal Apparatus

High flow Nasal Canula

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Adaptive Dynamic Inspiratory Nasal Apparatus (ADINA): Comparison to High Flow Nasal Cannula (HFNC)
Actual Study Start Date : 2025-09
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 23 Weeks to 40 Weeks
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

ADINA vs. High Flow Nasal Cannula Comparison Study

Location Details

NCT03171129


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, California

Loma Linda University Medical Center

Loma Linda, California, United States, 92354

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