CompletedNot Applicable

Automated Versus Manual Oxygen Control in Preterm Babies on Respiratory Support

Pakistan26 participantsStarted 2024-10-03

Plain-language summary

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.

Who can participate

Age range

13 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of time with SpO2 within the target range

Timeframe: 12 hours on each arm

Trial details

NCT IDNCT06622161

SponsorAga Khan University Hospital, Pakistan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-01

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