IntellO2 vs Manual Control for Optimizing Oxygenation in Infants

Vapotherm

Status: Completed

Conditions: Oxygen Titration in Preterm Infants to Manage Lung Disease

Treatments: Device: IntellO2; Other: Manual control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02074774

RP-NIAE2014001Reg

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

IntellO2

Experimental group

Description:

Automated control of FiO2

Treatment:

Device: IntellO2

Manual

Active Comparator group

Description:

Manual control of FiO2

Treatment:

Other: Manual control