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

April 25, 2021 updated by: South Tees Hospitals NHS Foundation Trust

A Randomized Control Trial of Oxygen Assist Module in Preterm Infants on High Flow Nasal Cannula Support (ROAM)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Supplemental oxygen remains by far the most commonly used 'drug' in neonatal intensive care units. The goal of oxygen therapy is to maintain normal oxygenation while minimizing hypoxemia and hypoxemia. Preterm infants are particularly vulnerable to oxygen toxicity and oxidative stress leading to retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and periventricular leukomalacia (PVL). It's also well known that preterm infants experience hypoxic events which are primarily linked to cardiovascular instability and apnea of prematurity. These events vary as the infant matures. Martin R et al showed in their study that these hypoxic events peaked around 2-4 weeks and decreases by 6-8 weeks in preterm infants . Exposure to prolonged and frequent hypoxemic episodes has been associated with increased morbidity and mortality . Prolonged hypoxic events (Saturation less than 80% for more than 1 minute) have been associated with severe ROP and impaired neurodevelopmental outcome in survivors . Very high oxygen levels are equally harmful.

Peripheral oxygen saturation monitoring is standard of care in infants admitted to neonatal unit. Traditionally oxygen saturation (SpO2) targeting is carried out by manual adjustment of fraction of inspired oxygen (FiO2) by the caregiver based on the monitored oxygen saturation. However, in practice this is only partially achieved during routine care[6]. Hagadorn et al conducted a study in 14 centers and showed that preterm infants under 28 weeks' gestation receiving oxygen spent on average only 48% of the time with SpO2 within the prescribed target range, about 36% of the time above and 16% of the time with SpO2 below the target range.

Preterm infants have frequent fluctuations in SpO2 due to their cardio-respiratory instability requiring frequent adjustments of FiO2 . Consequently, these particularly vulnerable infants spend significant time with SpO2 outside intended range and are often exposed to extremes of hypoxemia and hyperoxaemia. The automatic oxygen control system continuously monitors the oxygen saturation and adjusts the oxygen delivery to maintain oxygen saturation within the target range. The safety, feasibility and efficacy of this mode of oxygen control have already been established. Automated control of FiO2 significantly improves compliance of oxygen saturation targeting and significantly reduces exposure to hypoxemia as well as hyperoxaemia. Automatic control of oxygen delivery is available in both invasive and non-invasive mode of ventilation. The HFNC Therapy is a common mode of non-invasive respiratory support in preterm infants. Oxygen Assist Module (OAM) is a system of automatic oxygen control available in the HFNC (Vapotherm Precision Flow).

Previous study looking at the efficacy of automated oxygen control with HFNC support mostly have been a crossover model and the study duration less than 48 hours . As previously mentioned, preterm infants experience hypoxic events for few weeks before cardiopulmonary maturation is established. Hence, it's important to study these events over a longer period of time. The objective of this randomized control trial is to evaluate the efficacy of OAM (Automatic oxygen Control) in reducing the extremes of oxygen saturations in preterm infants (<80% and >98%) through the entire period of HFNC respiratory support.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm infants {born at a gestation <33 weeks (23+0 to 32+6 weeks) }
  • Receiving HFNC as respiratory support anytime during their stay in the neonatal support

Exclusion Criteria:

  • Preterm infants more than equal to 33 weeks.
  • Preterm infants with major congenital or chromosomal anomalies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Automatic control of FiO2
Infants randomized to this arm will be monitored using automatic oxygen control system on the High Flow Nasal Cannula. When infants oxygen saturation are out of the target range the OAM module on HFNC will adjust the oxygen delivery depending on the saturation of the infant to bring the saturation in the target range.
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).
Active Comparator: Manual Control of FiO2
Infants randomized to this arm will be receive oxygen delivery adjustments manually by the nursing and medical team taking care of the infants. When the infants oxygen saturation are out of the target range, the staff will manually adjust the oxygen delivery.
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%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of time spent in extreme saturation (<80% and >98%) in preterm infants receiving HFNC as respiratory support.
Time Frame: Through study completion on an average of 3 months
The primary outcome of this study is proportion of time spent in extreme saturation (<80% and >98%) in preterm infants receiving HFNC as respiratory support.
Through study completion on an average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of time spent in target saturation
Time Frame: Through study completion on an average of 3 months
Proportion of time spent in target saturation
Through study completion on an average of 3 months
Proportion of time spent in saturation >95%
Time Frame: Through the study completion on an average of 3 months
Proportion of time spent in saturation >95%
Through the study completion on an average of 3 months
episodes of prolonged hypoxemia (SpO2 < 80% for more than 60 sec)
Time Frame: Through study completion on an average of 3 months
episodes of prolonged hypoxemia (SpO2 < 80% for more than 60 sec)
Through study completion on an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Tees Hospitals NHS Foundation Trust

Collaborators

Vapotherm, Inc.

Investigators

  • Principal Investigator: Vrinda Nair, South Tees NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

November 1, 2020

First Submitted That Met QC Criteria

December 28, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 25, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 291497

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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