Measuring Oxygenation of Newborn Infants in Targeted Oxygen Ranges (MONITOR)

March 10, 2022 updated by: University of Edinburgh

Describing the Differences in Oxygen Profiles in Premature Infants of Less Than 29 Weeks Gestational Age When Targeted to an Oxygen Saturation Range 92 to 97%, Compared to 90 to 95%

The investigators aim to measure the effect of targeting premature babies to a slightly higher oxygen saturation target range (92-97%) than routinely used, for a brief period, to plan a future larger study of the effect of this on clinical outcomes.

It is still unclear exactly what levels of oxygen premature babies need - both too little or too much oxygen in the first weeks after birth may be harmful. Previous studies used saturation monitoring (SpO2), where a small probe shines light through the skin and calculates how much oxygen is carried in the blood. These studies demonstrated using an SpO2 range of 91-95% rather than 85-89% was associated with more babies surviving and fewer babies suffering from a bowel condition called necrotising enterocolitis (NEC). However, targeting oxygen higher increased the number of infants who needed treatment for an eye condition called retinopathy of prematurity (ROP).

It is possible an SpO2 range higher than 91-95% would be associated with even better survival. It is also possible that a higher range might not improve survival but could increase the need for ROP treatment.

Infants born at less than 29 weeks gestation, greater than 48 hours of age and receiving supplementary oxygen would be eligible for inclusion. The study is at the Royal Infirmary of Edinburgh. Total study time is 12 hours for each infant (6 hours at the standard 90-95% range used in our unit, and 6 hours at 92-97%). It is a crossover study with infants acting as their own controls.

Based on previous research the investigators are confident these oxygen levels will not be dangerously high. To provide an additional measure of oxygen the investigators will also use a transcutaneous monitor for the 12 hour study period, which fastens gently to the skin and measures oxygen and carbon dioxide levels on the skin surface.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a single centre randomised crossover study. Infants born at less than 29 weeks gestation, greater than 48 hours of age and receiving supplementary oxygen would be eligible for inclusion. The study is at the Royal Infirmary of Edinburgh. Total study time is 12 hours for each infant (6 hours at the standard 90-95% range used in our unit, and 6 hours at 92-97%). It is a crossover study with infants acting as their own controls.

A complete list of all monitoring that will be carried out is shown below:

  1. SpO2 monitoring
  2. TcPO2 monitoring
  3. Heart rate monitoring (used to validate SpO2 readings as described below)
  4. Arterial gas sampling (only if conducted by the direct care team as part of the routine care of the infant will these be recorded. No extra blood samples will be taken as part of the study)

Each infant will be monitored simultaneously with an SpO2 monitor and TcPo2 monitor, with data recording starting from the time the transcutaneous monitor finishes calibrating. SpO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will be measured using a Siemens Infinity SC7000 multiparameter monitor. This monitor uses Siemens' Oxisure pulse oximetry technology and Nellcor Oximax saturation probes and incorporates ECG to reduce motion artefact. To reduce the influence of artefact further, data from an infants chest leads (recording heart rate) will also be downloaded. If there is a greater than 10 beats per minute difference between heart rate measured from the pulse oximeter and heart rate measured from the chest leads, SpO2 for that time point will be disregarded.

TcPO2 will be measured using a SenTec Digital Monitoring System with OxiVent sensor. TcPO2 is calculated by dynamic fluorescence quenching which measures oxygen molecules present in the vicinity of a fluorescent dye incorporated within the sensor surface. The sensor is operated at a constant temperature of 43 degrees Celsius. Control of sensor temperature and application duration are designed to meet all applicable standards and this monitoring device is used routinely in many neonatal units, with transcutaneous monitoring part of the monitoring equipment we use in selected infants in our unit and being transported by our local neonatal transport team. Temperature is supervised by two independent circuits, as well as by the monitor firmware.

Transcutaneous data will be transferred contemporaneously to a bedside PC via the proprietary software V-STATS (with V-CareNeT) version 4.01. We will ensure the time on the monitor is synchronised with the time displayed on the electronic patient record system recording SpO2 and heart rate. V-STATS software can identify any spurious spikes in TcPO2 caused by air bubbles and these identified segments of data will be discarded. Artefact has not significantly affected readings during the routine use of this monitor previously on our neonatal unit and with our neonatal transport team. The site of the transcutaneous probe will be rotated on each infant every 2 hours.

SpO2, TcPO2 and heart rate data will be recorded every second. The time of any arterial oxygen samples taken routinely during the study will be recorded from the unit Radiometer ABL800 FLEX blood gas analyser.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Locations

  • United Kingdom
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Neonatal Unit - Royal Infirmary of Edinburgh

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Infants born at less than 29 weeks gestation
  • Infants greater than 48 hours of age
  • Infants who are receiving supplementary oxygen

Exclusion Criteria:

  • Congenital anomalies that would affect oxygenation (eg. cardiac defects, congenital diaphragmatic hernia)

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Higher target range
Infants will be targeted to 92-97% oxygen saturation
Other: Higher target range
Intervention is using a higher oxygen saturation target range than in routine practice
Other Names:
  • Using a higher oxygen saturation target range
No Intervention: Standard target range
Infants will be targeted to 90-95% oxygen saturation, which is the range used as routine in the Neonatal Unit involved in the study

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of hyperoxia and hypoxia on saturations
Time Frame: 12 hours
Percentage time spent above an SpO2 of 97% and below an SpO2 of 90% when infants are targeted to an SpO2 range of 92-97% compared to 90-95%
12 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of hyperoxia and hypoxia on Transcutaneous monitoring
Time Frame: 12 hours
To discover the percentage time spent above a TcPO2 of 80mmHg and below a TcPO2 of 50mmHg when infants are targeted to an SpO2 range of 92-97% compared to 90-95%
12 hours
Saturation variability
Time Frame: 12 hours
To discover the variability in SpO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 92-97% compared to 90-95%
12 hours
Transcutaneous variability
Time Frame: 12 hours
To discover the variability in TcPO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 92-97% compared to 90-95%
12 hours
Characterise PaO2 values within the two oxygen saturation target ranges
Time Frame: 12 hours
In infants who are undergoing PaO2 measurement as part of their routine care describe the PO2 values observed in the two target ranges
12 hours
Pooled frequency histogram of SpO2
Time Frame: 12 hours
To generate a pooled frequency histogram of percentage time at each SpO2 point between 80 and 100% for infants targeted to an SpO2 range of 92-97% compared to 90-95%
12 hours
Pooled frequency histogram of TcPO2
Time Frame: 12 hours
To generate a pooled frequency histogram of percentage time at a TcPO2 of below 30mmHg, 30-39.9mmHg, 40-49.9mmHg, 50-59.9mmHg, 60-69.9mmHg, 70-79.9mmHg, and 80mmHg and above for infants targeted to an SpO2 range of 92-97% compared to 90-95%
12 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Edinburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
NHS Lothian

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 18, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AC17098
  • 194632 (Registry Identifier: IRAS)

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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