Health TrialsbyHealthPanel

ADINA vs. High Flow Nasal Cannula Comparison Study

ConditionRespiratory Distress Neonatal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age23-40
SponsorLoma Linda University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Neonates admitted to NICU

Weights of 400-500 grams

Requiring oxygen greater than 30%

No evidence of focal lobar consolidation in lung fields

Disqualifiers

Intolerance to procedure

gelatinous skin

known allergy to adhesive material

interference with therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adaptive Dynamic Inspiratory Nasal Apparatus

    Device

    Oxygen will be administered via ADINA

  • High flow Nasal Canula

    Device

    Oxygen will be administered via nasal canula

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: High flow nasal cannula system w/ ADINAExperimental treatment 1 intervention
Group B: high flow nasal cannula systemActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Loma Linda University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: