Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants

Summary

Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability. Oxygen control in preterm infants requires frequent adjustments in the amount of oxygen delivered to the baby. This is generally performed manually by a clinician attending the baby, and generally directed to maintaining a specific range of blood oxygen saturation. The manual control often results in only half of the time in the specified range, with the baby experiencing high and low blood oxygen saturations.

The technology being studied is designed to assist the clinician in maintaining blood oxygen saturation within target range by measuring oxygen saturation and automatically adjusting the amount of oxygen delivered for babies receiving high velocity nasal insufflation (an advanced form of high flow oxygen therapy). The proposed study will evaluate the efficacy and safety of the automatic control of oxygen by the new technology, as compared to manual control, among babies receiving high velocity therapy in a neonatal intensive care unit.

Conditions

• Infant, Premature
• Neonatal Respiratory Distress
• Oxygen Saturation
• Bronchopulmonary Dysplasia

Interventions

DEVICE

Automated Control

The purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy.

DEVICE

Manual Control

The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy.

Sponsors & Collaborators

• Children's National Research Institute

  collaborator OTHER

• Seattle Children's Hospital

  collaborator OTHER

• University of Utah

  collaborator OTHER

• Vapotherm, Inc.

  lead INDUSTRY

Principal Investigators

• Billie L Short, MD · Children's National Research Institute

• Khodayar Rais-Bahrami, MD · Children's National Research Institute

• Robert J DiGeronimo, MD · Seattle Children's Hospital

• Robert DiBlasi, RRT-NPS · Seattle Children's Hospital

• Bradley A Yoder, MD · University of Utah Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-02

Primary Completion

2023-10-19

Completion

2023-10-19

FDA Device

Yes

Countries

• United States

Study Locations