Automated Versus Manual Oxygen Control in Preterm Babies on Respiratory Support

September 28, 2025 updated by: Ali Shabbir Hussain, Aga Khan University Hospital, Pakistan

Automated Oxygen Control in Preterm Babies on Respiratory Support: A Randomized Cross Over Study

Babies admitted in the NICU (neonatal intensive care unit) frequently need supplemental oxygen to keep their oxygen saturation (SpO2) in target range (TR). Hypoxia and hyperoxia episodes should be avoided while working toward this goal. Preterm babies are particularly vulnerable to abnormal oxygen levels, and adverse effects of hyperoxia and oxygen toxicity may result in retinopathy of prematurity and bronchopulmonary dysplasia. Similarly, mortality may rise due to hypoxic events. In routine practice, the SpO2 target is usually achieved by manual adjustment of FiO2 (fraction of inspired oxygen), but it usually does not accomplish the desired SpO2 target, leading to episodes of hyperoxia and hypoxia and increased risk of complications. A study was conducted in multiple centers involving extremely preterm babies, the results of which depicted that the babies on manual control of FiO2 spent only 48% of their time with SpO2 in the target range, 16% below the target range, and 36% above it. The compliance of the SpO2 target range was also variable in these centers. There is a need to improve compliance by using automated oxygen control systems.

At the Aga Khan University Hospital (AKUH) investigators have included SLE 6000 (SLE, Croydon, UK) ventilators in their NICU (neonatal intensive care unit) which have automated oxygen control device "Oxygenie" that continuously adjusts FiO2 (fraction of inspired oxygen) of the patient to keep SpO2 in the target range, avoiding abnormal oxygen levels. This also reduces the workload on staff and improves patient care. Investigators usually put preterm babies on these ventilators so that SpO2 can be kept most of the time in the target range. When the OxyGenie and SpO2 monitoring are added to the SLE 6000 ventilator, it becomes possible to accurately regulate and deliver closed loop oxygen to preterm infants. This automated oxygen control system limits episodes of both hypoxia and hyperoxia by using the VDL 1.1 algorithm that uses an adaptive Proportional-Integral-Derivative (PID) algorithm to control the FiO2 adjustments in response to changes in SpO2. This keeps SpO2 within a target range (TR) which user selects. A randomized crossover trial comparing two devices for automated oxygen control in preterm infants included the SLE 6000 ventilator as one of its devices.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators will conduct a radomized cross-over trial. 24 Preterm babies will be sampled, and to account for attrition, 26 preterm babies will be enrolled. Preterm babies born at less than 37 weeks of gestation will be included in the study. For each of the twelve-hour periods, they will be randomized to either manually controlled oxygen or automated oxygen control. After 12-hour periods, they will be shifted to alternate interventions. The total duration will be 24 hours. Written consent will be obtained from the parent/guardian before recruitment.

Block randomization will be done to randomize the babies. SLE 6000 ventilators will be used, and settings will be adjusted by the clinical team as per the clinical condition of the baby.

The Radical neonatal pulse oximeter (Masimo) is used to automatically adjust FiO2 in order to maintain SpO2 within a designated target range. Before turning on oxygen, FiO2 is manually adjusted to achieve SpO2 in the target range. Once stable SpO2 is achieved in TR, oxygen is turned on, which then adjusts FiO2 to keep SpO2 within target range. The FiO2 changes and their frequency are determined by the SpO2 trend, whether the SpO2 is above, below, or within the target range, and all changes are proportionate to the baseline FiO2 level. The pulse oximeter's settings will include normal sensitivity, an average time of 2-4 seconds, a 20-second alarm delay, and an alarm limit of 89% and 95% SpO2. Whenever feasible, the right wrist is used to apply the Masimo neonatal probe. The user will be advised on screen if the SpO2 signal will be lost. Oxygenie would display in blue, waiting for a signal, and would remain on the current FiO2 value for the first 60 seconds. After this point, if the SpO2 is within TR, it will continue at the current FiO2 level. If the SpO2 is above the TR and the FiO2 is 10% above the reference range, it will slowly decrease to the reference value. If SpO2 is below TR and FiO2 is more than 5% below the reference FiO2, then it will slowly increase to the reference level. The reference FiO2 value is updated every 30 minutes and is based on the last 60-minute average.

Study Type

Interventional

Enrollment (Actual)

26

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 Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University Hospital

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Investigators will include premature babies (born before 37 weeks of pregnancy) who are on SLE 6000 ventilator, and require additional oxygen therapy or respiratory support due to respiratory dysfunction.

Preterm babies will be included in the study if they will meet all the following criteria:

  • Receiving respiratory support via mechanical ventilation, either non-invasive or invasive
  • Receiving supplemental oxygen at the time of inclusion
  • Written informed parental consent

Exclusion Criteria:

  • Major Congenital Anomalies such as neural tube defects, neuromuscular disorders, congenital heart diseases, syndromic babies, and so forth.
  • Resuscitation and termination of mechanical ventilation during the study
  • Withdrawal of parent consent

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
Intervention / Treatment
Other: "automated oxygen,"
Preterm babies will be kept on the SLE 6000 ventilator for 12 hours, where an automated oxygen device called "oxygenie" will be used to automatically adjust FiO2 to keep SpO2 within the target range. After 12 hours, the other group will be kept on this arm for 12 hours.
Device: automated oxygen vs manual oxygen
Patient characteristics, ventilator, and blood gas parameters at the time of study will be shown in Tabular form. At the start of the study, half of the babies will be randomly assigned to a manual 12-hour period where a bedside nurse will adjust the FiO2 of the baby according to SpO2 levels, and half of the babies to an automated 12-hour period where Oxygenie will adjust FiO2 according to target SpO2 levels. After 12 hours, they will be shifted to contralateral intervention. The ventilator parameters (peak inspiratory pressure, positive end expiratory pressure, and rate) will be compared between the automated and manual 12-hour periods. The amount of time spent within different ranges of SpO2 will also be measured and shown in tabular form.
Other: "manual oxygen"
Preterm babies will be kept on the SLE 6000 ventilator for 12 hours, where manual FiO2 adjustment by the bedside staff nurse will be used to keep SpO2 within the target range. After 12 hours, the other group will be kept on this arm for 12 hours.
Device: automated oxygen vs manual oxygen
Patient characteristics, ventilator, and blood gas parameters at the time of study will be shown in Tabular form. At the start of the study, half of the babies will be randomly assigned to a manual 12-hour period where a bedside nurse will adjust the FiO2 of the baby according to SpO2 levels, and half of the babies to an automated 12-hour period where Oxygenie will adjust FiO2 according to target SpO2 levels. After 12 hours, they will be shifted to contralateral intervention. The ventilator parameters (peak inspiratory pressure, positive end expiratory pressure, and rate) will be compared between the automated and manual 12-hour periods. The amount of time spent within different ranges of SpO2 will also be measured and shown in tabular form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time with SpO2 within the target range
Time Frame: 12 hours on each arm
The primary outcome measure of time with SpO2 within the target range of 90-94% will be compared between automated and manual period.
12 hours on each arm

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of time with SpO2 above the target range and below the target range
Time Frame: 12 hours on each arm
The percentage of time with SpO2 above the target range (>94% and ≥98%) with FiO2 of >0.21 and below the target range (<90% and <80%) will be compared between both interventions.
12 hours on each arm
SpO2 fluctuations below 80% and 98% or above, and episodes of prolong hypoxia and hyperoxia
Time Frame: 12 hours on each arm
Between automated and routine care, we'll also track the number and median duration of SpO2 fluctuations below 80% and 98% or above, as well as episodes of prolong hypoxia and hyperoxia of one and three minutes
12 hours on each arm
Median FiO2 values and median number of manual adjustments of FiO2
Time Frame: 12 hours on each arm
Median FiO2 values and median number of manual adjustments of FiO2 will be compared between both automated and manual control periods
12 hours on each arm
% of Time with SpO2 in Target range (90-94%), <90%, and > 94%, with and without use of sedative and respiratory stimulant medications
Time Frame: 12 hours on each arm
The percentage of time with SpO2 in the target range (90-94%), below (<90%), and above (>94%) the target range when FiO2 > 21%, in babies with and without sedative and respiratory stimulant medication use (e.g., Morphine, Caffeine, etc.) will be compared
12 hours on each arm

Collaborators and Investigators

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

Sponsor

Aga Khan University Hospital, Pakistan

Investigators

  • Principal Investigator: Ali Shabbir Hussain, Aga Khan University Hospital, Karachi, Pakistan

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

Helpful Links

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)

October 3, 2024

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

August 13, 2025

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

September 30, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Estimated)

September 30, 2025

Last Update Submitted That Met QC Criteria

September 28, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10189

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

product manufactured in and exported from the U.S.

Yes

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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