IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-01-31

Brief Summary

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The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.

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Detailed Description

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Conditions

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Oxygen Titration in Preterm Infants to Manage Lung Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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IntellO2

Automated control of FiO2

Group Type EXPERIMENTAL

IntellO2

Intervention Type DEVICE

Automated FiO2 regulator that responds to pulse oximetry measures

Manual

Manual control of FiO2

Group Type ACTIVE_COMPARATOR

Manual control

Intervention Type OTHER

Standard practice of manually titrating FiO2 as needed.

Interventions

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IntellO2

Automated FiO2 regulator that responds to pulse oximetry measures

Intervention Type DEVICE

Manual control

Standard practice of manually titrating FiO2 as needed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Preterm infants being treated with high flow nasal cannula therapy
2. A need for supplemental oxygen as demonstrated by an required FiO2 \> 0.25 at enrollment
3. Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC).

Exclusion Criteria

1. Major congenital abnormalities
2. Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics
3. Seizures
4. Ongoing sepsis
5. Meningitis
6. Clinician's concern regarding stability of the infant

Eligible Sex

ALL

Accepts Healthy Volunteers

No