PretermNCT06622161
Automated Versus Manual Oxygen Control in Preterm Babies on Respiratory Support
A study testing automated oxygen vs manual oxygen in people with Preterm, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 13 weeks
- Conditions the study is for
- Preterm
- What is being tested?
- automated oxygen vs manual oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Oct 2024to 13 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 13 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm
- Being tested
- automated oxygen vs manual oxygen
- Keywords
- Respiratory, Hypoxia, Hyperoxia, Oxygen saturation, Target range
- Medical subject headings
- Premature Birth, Hypoxia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
automated oxygen vs manual oxygenDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| "automated oxygen," | Other | 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. Receives: Device: automated oxygen vs manual oxygen |
| "manual oxygen" | Other | 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. Receives: Device: automated oxygen vs manual oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time with SpO2 within the target range
The primary outcome measure of time with SpO2 within the target range of 90-94% will be compared between automated and manual period.
Measured: 12 hours on each arm
Secondary outcomes (4)
Percentage of time with SpO2 above the target range and below the target range
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.
Measured: 12 hours on each arm
SpO2 fluctuations below 80% and 98% or above, and episodes of prolong hypoxia and hyperoxia
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
Measured: 12 hours on each arm
Median FiO2 values and median number of manual adjustments of FiO2
Median FiO2 values and median number of manual adjustments of FiO2 will be compared between both automated and manual control periods
Measured: 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
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
Measured: 12 hours on each arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start3 Oct 2024
- Primary completion1 Mar 2025
- Study completion13 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Shabbir Hussain, Aga Khan University Hospital, Pakistan
- Investigators
- Ali Shabbir Hussain, Principal investigator, Aga Khan University Hospital, Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622161
- Sponsor's protocol ID
- 10189
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2024
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnston ED, Boyle B, Juszczak E, King A, Brocklehurst P, Stenson BJ. Oxygen targeting in preterm infants using the Masimo SET Radical pulse oximeter. Arch Dis Child Fetal Neonatal Ed. 2011 Nov;96(6):F429-33. doi: 10.1136/adc.2010.206011. Epub 2011 Mar 6.
PubMed 21378398van Kaam AH, Hummler HD, Wilinska M, Swietlinski J, Lal MK, te Pas AB, Lista G, Gupta S, Fajardo CA, Onland W, Waitz M, Warakomska M, Cavigioli F, Bancalari E, Claure N, Bachman TE. Automated versus Manual Oxygen Control with Different Saturation Targets and Modes of Respiratory Support in Preterm Infants. J Pediatr. 2015 Sep;167(3):545-50.e1-2. doi: 10.1016/j.jpeds.2015.06.012. Epub 2015 Jul 2.
PubMed 26144575Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
PubMed 20732945SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Schibler K, Newman NS, Ambalavanan N, Frantz ID 3rd, Piazza AJ, Sanchez PJ, Morris BH, Laroia N, Phelps DL, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Ehrenkranz RA, Watterberg KL, Higgins RD. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16.
PubMed 20472937Stenson B, Brocklehurst P, Tarnow-Mordi W; U.K. BOOST II trial; Australian BOOST II trial; New Zealand BOOST II trial. Increased 36-week survival with high oxygen saturation target in extremely preterm infants. N Engl J Med. 2011 Apr 28;364(17):1680-2. doi: 10.1056/NEJMc1101319. No abstract available.
PubMed 21524227Laptook AR, Salhab W, Allen J, Saha S, Walsh M. Pulse oximetry in very low birth weight infants: can oxygen saturation be maintained in the desired range? J Perinatol. 2006 Jun;26(6):337-41. doi: 10.1038/sj.jp.7211500.
PubMed 16598294Hagadorn JI, Furey AM, Nghiem TH, Schmid CH, Phelps DL, Pillers DA, Cole CH; AVIOx Study Group. Achieved versus intended pulse oximeter saturation in infants born less than 28 weeks' gestation: the AVIOx study. Pediatrics. 2006 Oct;118(4):1574-82. doi: 10.1542/peds.2005-0413.
PubMed 17015549Salverda HH, Oldenburger NJ, Rijken M, Pauws SC, Dargaville PA, Te Pas AB. The effect of automated oxygen control on clinical outcomes in preterm infants: a pre- and post-implementation cohort study. Eur J Pediatr. 2021 Jul;180(7):2107-2113. doi: 10.1007/s00431-021-03982-8. Epub 2021 Feb 23.
PubMed 33619593Dargaville PA, Sadeghi Fathabadi O, Plottier GK, Lim K, Wheeler KI, Jayakar R, Gale TJ. Development and preclinical testing of an adaptive algorithm for automated control of inspired oxygen in the preterm infant. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F31-F36. doi: 10.1136/archdischild-2016-310650. Epub 2016 Sep 15.
PubMed 27634820Gajdos M, Waitz M, Mendler MR, Braun W, Hummler H. Effects of a new device for automated closed loop control of inspired oxygen concentration on fluctuations of arterial and different regional organ tissue oxygen saturations in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F360-F365. doi: 10.1136/archdischild-2018-314769. Epub 2018 Aug 28.
PubMed 30154236Salverda HH, Cramer SJE, Witlox RSGM, Gale TJ, Dargaville PA, Pauws SC, Te Pas AB. Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):20-25. doi: 10.1136/archdischild-2020-321387. Epub 2021 Jun 10.
PubMed 34112721Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
PubMed 30974433Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.
PubMed 30464005Salverda HH, Cramer SJE, Witlox RSGM, Dargaville PA, Te Pas AB. Automated oxygen control in preterm infants, how does it work and what to expect: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021 Mar;106(2):215-221. doi: 10.1136/archdischild-2020-318918. Epub 2020 Jul 30.
PubMed 32732378Chan AW, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, Dickersin K, Hrobjartsson A, Schulz KF, Parulekar WR, Krleza-Jeric K, Laupacis A, Moher D. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013 Jan 8;346:e7586. doi: 10.1136/bmj.e7586.
PubMed 23303884
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Oxygen Control in Preterm Babies on Respiratory Support: A Randomized Cross Over Study
- ClinicalTrials.gov ID
- NCT06622161
- Acronym / sponsor ID
- 10189
- Conditions
- Preterm
- Keywords
- Respiratory, Hypoxia, Hyperoxia, Oxygen saturation, Target range
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 13 Aug 2025 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "automated oxygen," | Other | Device: automated oxygen vs manual oxygenPreterm 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. |
| "manual oxygen" | Other | Device: automated oxygen vs manual oxygenPreterm 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. |
Who may qualify
- Ages
- Up to 13 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| automated oxygen vs manual oxygenPatient 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. | Device | "automated oxygen,", "manual oxygen" |
Primary outcome
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.
4 secondary outcomes
Percentage of time with SpO2 above the target range and below the target range
Time frame: 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
Median FiO2 values and median number of manual adjustments of FiO2
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Background: PubMed 21378398Johnston ED, Boyle B, Juszczak E, King A, Brocklehurst P, Stenson BJ. Oxygen targeting in preterm infants using the Masimo SET Radical pulse oximeter. Arch Dis Child Fetal Neonatal Ed. 2011 Nov;96(6):F429-33. doi: 10.1136/adc.2010.206011. Epub 2011 Mar 6.
- Background: PubMed 26144575van Kaam AH, Hummler HD, Wilinska M, Swietlinski J, Lal MK, te Pas AB, Lista G, Gupta S, Fajardo CA, Onland W, Waitz M, Warakomska M, Cavigioli F, Bancalari E, Claure N, Bachman TE. Automated versus Manual Oxygen Control with Different Saturation Targets and Modes of Respiratory Support in Preterm Infants. J Pediatr. 2015 Sep;167(3):545-50.e1-2. doi: 10.1016/j.jpeds.2015.06.012. Epub 2015 Jul 2.
- Background: PubMed 20732945Stoll BJ, Hansen NI, Bell EF, Shankaran S, Laptook AR, Walsh MC, Hale EC, Newman NS, Schibler K, Carlo WA, Kennedy KA, Poindexter BB, Finer NN, Ehrenkranz RA, Duara S, Sanchez PJ, O'Shea TM, Goldberg RN, Van Meurs KP, Faix RG, Phelps DL, Frantz ID 3rd, Watterberg KL, Saha S, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neonatal outcomes of extremely preterm infants from the NICHD Neonatal Research Network. Pediatrics. 2010 Sep;126(3):443-56. doi: 10.1542/peds.2009-2959. Epub 2010 Aug 23.
- Background: PubMed 20472937SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Carlo WA, Finer NN, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Schibler K, Newman NS, Ambalavanan N, Frantz ID 3rd, Piazza AJ, Sanchez PJ, Morris BH, Laroia N, Phelps DL, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Ehrenkranz RA, Watterberg KL, Higgins RD. Target ranges of oxygen saturation in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1959-69. doi: 10.1056/NEJMoa0911781. Epub 2010 May 16.
- Background: PubMed 21524227Stenson B, Brocklehurst P, Tarnow-Mordi W; U.K. BOOST II trial; Australian BOOST II trial; New Zealand BOOST II trial. Increased 36-week survival with high oxygen saturation target in extremely preterm infants. N Engl J Med. 2011 Apr 28;364(17):1680-2. doi: 10.1056/NEJMc1101319. No abstract available.
- Background: PubMed 16598294Laptook AR, Salhab W, Allen J, Saha S, Walsh M. Pulse oximetry in very low birth weight infants: can oxygen saturation be maintained in the desired range? J Perinatol. 2006 Jun;26(6):337-41. doi: 10.1038/sj.jp.7211500.
- Background: PubMed 17015549Hagadorn JI, Furey AM, Nghiem TH, Schmid CH, Phelps DL, Pillers DA, Cole CH; AVIOx Study Group. Achieved versus intended pulse oximeter saturation in infants born less than 28 weeks' gestation: the AVIOx study. Pediatrics. 2006 Oct;118(4):1574-82. doi: 10.1542/peds.2005-0413.
- Background: PubMed 33619593Salverda HH, Oldenburger NJ, Rijken M, Pauws SC, Dargaville PA, Te Pas AB. The effect of automated oxygen control on clinical outcomes in preterm infants: a pre- and post-implementation cohort study. Eur J Pediatr. 2021 Jul;180(7):2107-2113. doi: 10.1007/s00431-021-03982-8. Epub 2021 Feb 23.
- Background: PubMed 27634820Dargaville PA, Sadeghi Fathabadi O, Plottier GK, Lim K, Wheeler KI, Jayakar R, Gale TJ. Development and preclinical testing of an adaptive algorithm for automated control of inspired oxygen in the preterm infant. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F31-F36. doi: 10.1136/archdischild-2016-310650. Epub 2016 Sep 15.
- Background: PubMed 30154236Gajdos M, Waitz M, Mendler MR, Braun W, Hummler H. Effects of a new device for automated closed loop control of inspired oxygen concentration on fluctuations of arterial and different regional organ tissue oxygen saturations in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F360-F365. doi: 10.1136/archdischild-2018-314769. Epub 2018 Aug 28.
- Background: PubMed 34112721Salverda HH, Cramer SJE, Witlox RSGM, Gale TJ, Dargaville PA, Pauws SC, Te Pas AB. Comparison of two devices for automated oxygen control in preterm infants: a randomised crossover trial. Arch Dis Child Fetal Neonatal Ed. 2022 Jan;107(1):20-25. doi: 10.1136/archdischild-2020-321387. Epub 2021 Jun 10.
- Background: PubMed 30974433Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
- Automated Oxygen Delivery in Neonatal Intensive CareLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Shabbir Hussain principal investigator
Aga Khan University Hospital, Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automated oxygen vs manual oxygen in people with Preterm, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of time with SpO2 within the target range (time frame: 12 hours on each arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06622161, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.