Oxygen Assist Module in Preterm Infants on High Flow Nasal Cannula Support.

Summary

Oxygen treatment is common in babies born early (preterm) and requiring intensive care. Having too much or too little oxygen can increase the risk of damage to the eyes and lungs, and contribute to death or disability. Preterm infants because of their immaturity experience episodes of low oxygen levels. The low oxygen episodes are primarily due to pauses in their breathing (Apnoea of prematurity) and immaturity of their lung. These episodes persist for weeks to months. The lower the gestation at birth the longer the duration of these events. Studies have shown that these episodes of low oxygen saturations especially if frequent and prolonged is associated with poor developmental outcome, severe eye disease and lung disease.

Traditionally, the oxygen delivery is manually adjusted when infant has low oxygen saturation. However previous studies have shown despite the best efforts the oxygen level can only be maintained less than half of the time and nearly a one-fifth of the time infant spends in low oxygen levels and nearly one-third of the time in high oxygen levels. With advancement in the neonatal care, preterm infants tend to spend more time on non invasive respiratory support. Now it is possible to maintain oxygen level in target range by using automatic control of oxygen delivery on non invasive support. With the proposed study, we would like to study the efficacy of automatic control of oxygen delivery in reducing the time spent in very low and high oxygen levels when infants are on non invasive respiratory support namely High Flow Nasal Cannula support.

Conditions

• Preterm Birth

Interventions

DEVICE

High Flow Nasal Cannula withAutomatic control of FiO2 using OAM

The target oxygen saturation (SpO2) value will to be determined and set by the clinician according to specific patient needs. The target SpO2 in preterm infants is 90-95% with alarm limits at 89-96%. In automatic control of oxygen, the OAM automatically increases or decreases the FiO2 (oxygen delivery) setting on the Vapotherm Precision Flow based on pulse oximetry readings of the OAM. The target saturation will be set at 93% and the FiO2 will be adjusted by OAM to maintain the target saturation. The automated FiO2 setting can be overridden for a clinician pre-set period of time (30-120 sec) by simply manually adjusting the FiO2 on the Precision Flow. Automated control resumes after the clinicians pre-set period of time (30-120 sec) based on the current SpO2 and FiO2. The OAM utilizes a feedback control algorithm that receives a patient's oxygen saturation value from a build in pulse oximetry device (Masimo SET OEM - normal sensitivity, averaging time window set at 8 seconds).

DEVICE

High Flow Nasal Cannula with manual control of FiO2

In manual control of oxygen all FiO2 adjustments will be done by the clinical staff to maintain saturations between 90-95%. The alarm limits will be 89-96%.

Sponsors & Collaborators

• Vapotherm, Inc.

  collaborator INDUSTRY

• South Tees Hospitals NHS Foundation Trust

  lead OTHER

Principal Investigators

• Vrinda Nair · South Tees NHS Trust

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

32 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-15

Primary Completion

2022-12-31

Completion

2023-04-30

Countries

• United Kingdom

Study Locations