Neonatal Respiratory Distress Related ConditionsNCT05508308

Automated Versus Manual Control Of Oxygen For Preterm Infants On Continuous Positive Airway Pressure In Nigeria

A study testing OxyMate in people with Neonatal Respiratory Distress Related Conditions and Neonatal Respiratory Failure, run by Murdoch Childrens Research Institute at 2 sites in Nigeria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 12 hours to 1 month
Conditions the study is for: Neonatal Respiratory Distress Related Conditions, Neonatal Respiratory Failure, Prematurity
What is being tested?: OxyMate
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 49 participants
Where: 2 sitesNigeria
Study dates: 13 Sep 2022to 29 Sep 2023
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 12 hours to 1 month
All sexes
No healthy volunteers
Child

Who may be able to join

<34 weeks gestation (or birth weight < 2kg if gestation not known)
≥12 hours old
Receiving CPAP support and supplemental oxygen (FiO2 >0.21) for respiratory insufficiency
Projected requirement for CPAP and oxygen therapy for > 48 hours

Who cannot join

Deemed likely to fail CPAP in the next 48 hours
Deemed clinically unstable or recommended for palliation by treating team
Cause of hypoxaemia likely to be non-respiratory - e.g. cyanotic heart disease
Informed consent from parent/guardians not obtained

Trial locations and contacts

2 sites in 1 country.

Nigeria2 sites

University College Hospital
Agodi, Ibadan, 200285
Sacred Heart Hospital
Lantoro, Abeokuta, 111101

Other trials in Nigeria

About this study

Official title: Automated Oxygen Control for Preterm Infants On Continuous Positive Airway Pressure (CPAP): Phase 1/2 Trial In Southwest Nigeria

One in ten babies are born preterm (<37 weeks gestation) globally. Complications of prematurity are the leading cause of death in children under 5 years, with the highest mortality rate in Sub-Saharan Africa (SSA). Low flow oxygen, and respiratory support - where an oxygen/air mixture is delivered under pressure - are life saving therapies for these babies. Bubble Continuous Positive Airway Pressure (bCPAP) is the mainstay of neonatal respiratory support in SSA.

Oxygen in excess can damage the immature eyes (Retinopathy of Prematurity [ROP]) and lungs (Chronic Lung Disease) of preterm babies. Historically, in well-resourced settings, excessive oxygen administration to newborns has been associated with 'epidemics' of ROP associated blindness. Today, with increasing survival of preterm babies in SSA, and increasing access to oxygen and bCPAP, there are concerns about an emerging epidemic of ROP. Manually adjusting the amount of oxygen provided to an infant on bCPAP is difficult, and fearing the risks of hypoxaemia (low oxygen levels) busy health workers often accept hyperoxaemia (excessive oxygen levels). Some well resourced neonatal intensive care units globally have adopted Automated Oxygen Control (AOC), where a computer uses a baby's oxygen saturation by pulse oximetry (SpO2) to frequently adjust how much oxygen is provided, targetting a safe SpO2 range. This technology has never been tested in SSA, or partnered with bCPAP devices that would be more appropriate for SSA.

This study aims to compare AOC coupled with a low cost and robust bCPAP device (Diamedica Baby CPAP) - OxyMate - with manual control of oxygen for preterm babies on bCPAP in two hospitals in south west Nigeria. The hypothesis is that OxyMate can significantly and safely increase the proportion of time preterm infants on bCPAP spend in safe oxygen saturation levels.

Read the detailed description

Trial description: A randomised cross-over trial of manual versus automated control of oxygen (OxyMate) for preterm infants on bCPAP. This trial will use an established technology (automated oxygen titration algorithm, VDL1.1) partnered with a low-cost bCPAP device in a low-resource setting. It will involve preterm infants requiring bCPAP respiratory support with allocation to OxyMate or manual oxygen control for consecutive 24 h periods in random sequence.

Objectives: This trial seeks to examine safety and potential efficacy of our automated oxygen configuration (OxyMate) in preterm infants in a setting characterised by financial constraints, workforce limitations, and underdeveloped infrastructure, and assess contextual feasibility and appropriateness to inform future definitive clinical trials and product development.

Conditions: Neonatal Respiratory Distress Related Conditions, Neonatal Respiratory Failure, Prematurity, Oxygen Toxicity
Being tested: OxyMate, Manual oxygen control
Medical subject headings: Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OxyMateDevice
Automated Oxygen Control algorithm (VDL 1.1) coupled with Diamedica Baby CPAP device
Manual oxygen controlOther
Guidelines and training in FiO2 titration to achieve a target range of SpO2. Health workers instructed in responding to continuous pulse oximetry readings and alarms

Study groups in NCT05508308
Study group	Role	What they receive
Manual oxygen control	Active comparator	Oxygen therapy delivered with bCPAP as per standard practice, except for the addition of continuous pulse oximetry. Nursing staff will make manual adjustments to Fraction of Inspired Oxygen (FiO2) provided to infants on bCPAP. Oxygen saturations (SpO2) will be monitored by continuous pulse oximetry, and nurses asked to target the range of SpO2 91-95%. Pulse oximeter alarms will be set to alert nurses to periods of hypoxaemia (SpO2<88%) and hyperoxaemia (SpO2>96%). Receives: Other: Manual oxygen control
OxyMate Automated Oxygen Control	Experimental	Automated control of oxygen therapy partnered with bCPAP delivered as per standard practice. The automated oxygen control set-up (OxyMate) will consist of: continuous pulse oximetry input, a computer algorithm (VDL1.1) that calculates changes to delivered FiO2 based on the input SpO2, and a mechanism to automatically effect changes to delivered FiO2. The system will target an SpO2 of 93% (mid-point of the target range). There will be several embedded safety mechanisms, including the ability to manually over-ride OxyMate at any stage. Pulse oximeter alarms will be as for the manual control arm, with additional automated system alarms in place. Receives: Device: OxyMate

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of time in target SpO2 range
Proportion of time (over total recorded time) in the target SpO2 range (91-95%, or 91-100% when in room air). Measured as %time
Measured: Measured for each 24 hour study epoch

Secondary outcomes (20)

Proportion of time in target SpO2 range when receiving supplemental oxygen
Proportion of time (over total recorded time) in SpO2 target range (91-95%) when receiving supplemental oxygen. Measured as %time when receiving oxygen
Measured: Measured for each 24 hour study epoch
Proportion of time in hypoxaemia
Proportion of time (over total recorded time) with SpO2<90% (hypoxaemia). Measured as %time
Measured: Measured for each 24 hour study epoch
Proportion of time in severe hypoxaemia
Proportion of time (over total recorded time) with SpO2 <80% (severe hypoxaemia). Measured as %time
Measured: Measured for each 24 hour study epoch
Frequency of prolonged hypoxaemia episodes
Frequency of 30 seconds episodes with SpO2 continuously <80% (severe hypoxaemic episodes). Measured as episodes per hour
Measured: Measured for each 24 hour study epoch
Proportion of time in hyperoxaemia
Proportion of time (over total recorded time) with SpO2 >96% when receiving supplemental oxygen (hyperoxaemia). Measured as %time when receiving oxygen
Measured: Measured for each 24 hour study epoch
Proportion of time in severe hyperoxaemia
Proportion of time (over total recorded time) with SpO2 >98% when receiving supplemental oxygen (severe hyperoxaemia). Measured as %time when receiving oxygen
Measured: Measured for each 24 hour study epoch
Frequency of prolonged hyperoxaemia episodes
Frequency of 30 seconds episodes with SpO2 continuously >96% (hyperoxaemic episodes). Measured as episodes per hour
Measured: Measured for each 24 hour study epoch
Manual FiO2 adjustments
Frequency of manual FiO2 adjustments. Measured as FiO2 adjustments/hour
Measured: Measured for each 24 hour study epoch
No response to prolonged severe hypoxaemia (frequency)
Number of periods of no FiO2 increment for ≥30 seconds with SpO2 <80% (i.e. failure to respond to severe hypoxaemia). Measured as episodes per hour
Measured: Measured for each 24 hour study epoch
No response to prolonged severe hypoxaemia (duration)
Duration of periods of no FiO2 increment for ≥30 seconds with SpO2 <80% (i.e. failure to respond to severe hypoxaemia). Measured as mean duration per episode
Measured: Measured for each 24 hour study epoch
Severe hypoxaemia with bradycardia (frequency)
Number of periods with SpO2 <80% for ≥30 seconds with any bradycardia (heart rate <100 bpm). Measured as episodes per hour
Measured: Measured for each 24 hour study epoch
Severe hypoxaemia with bradycardia (duration)
Duration of periods with SpO2 <80% for ≥30 seconds with any bradycardia (heart rate <100 bpm). Measured as mean duration per episode
Measured: Measured for each 24 hour study epoch
Device malfunction
Number of OxyMate malfunction events
Measured: Measured through to OxyMate study completion: estimated 20 weeks
Acceptability and usability
Mean/median user acceptability score (total and per question) on Likert scale from structured questionnaire. Scores range from 1 (strongly disagree) to 5 (strongly agree) with posed statement or question
Measured: Completed for each participant (health workers) at end of an infant's study period (49 hours). Results recorded for unique health workers through to OxyMate study completion: estimated 20 weeks
Costs
Total costs of prototype system (Diamedica +/- Automated Oxygen control - OxyMate)
Measured: Measured at completion of OxyMate study: an estimated 20 weeks
Duration of CPAP and oxygen therapy
Duration of time on CPAP with supplemental oxygen. Measured in hours
Measured: Completed for each participant at end of their study period: 49 hours from study commencement
CPAP in room air
Duration of time on CPAP in room air. Measured in hours
Measured: Completed for each participant at end of their study period: 49 hours from study commencement
Time on low flow oxygen
Duration of time on low-flow oxygen therapy. Measured in hours
Measured: Completed for each participant at end of their study period: 49 hours from study commencement
Final discharge outcome
Measured as categorical outcome (died in hospital, discharged well, discharged against medical advice, other)
Measured: Up to 4 weeks post enrollment
Length of stay
Measured in days
Measured: Up to 4 weeks post enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Sep 202229 Sep 2023

First posted19 Aug 2022
Study start13 Sep 2022
Primary completion29 Sep 2023
Study completion29 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Neonatal Respiratory Distress Related ConditionsStudies of the same condition, open and under way.
More trials run by Murdoch Childrens Research InstituteThe sponsor's other registered studies.
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
Model description: Preterm infants on bCPAP are managed with each mode of oxygen control for 24 hours, prior to crossing over to the other mode of control. Change over simply involves flicking the computer switch from manual to automated control (or vice versa) and it is enacted immediately. It does not require any adjustment or interruption of the CPAP and it does not involve additional action from clinical staff. While the fraction of inspired oxygen (FiO2) adjustments have their effect relatively rapidly, we will apply a 1 h washout period (dropping this data from analysis) to avoid contamination between arms.
Masking: None (open label)
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05508308
Sponsor's protocol ID: HREC84704
Status last verified: Nov 2023
First submitted: 12 Aug 2022
Last updated: 13 Nov 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The de-identified data set collected for the final analysis of the OxyMate trial will be available two months after publication of the primary outcome. Documents that will be made available are Study Protocol and Informed Consent Form. Data may be obtained from the Murdoch Children's Research Institute (MCRI) by emailing hamish.graham@mcri.edu.au and mctc@mcri.edu.au

Publications

Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, Lewis C, Rattanakanokchai S, Teng DN, Thinkhamrop J, Watananirun K, Zhang J, Zhou W, Gulmezoglu AM. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019 Jan;7(1):e37-e46. doi: 10.1016/S2214-109X(18)30451-0. Epub 2018 Oct 30.
PubMed 30389451
WHO Recommendations on Interventions to Improve Preterm Birth Outcomes. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321160/
PubMed 26447264
Gilbert C. Retinopathy of prematurity: a global perspective of the epidemics, population of babies at risk and implications for control. Early Hum Dev. 2008 Feb;84(2):77-82. doi: 10.1016/j.earlhumdev.2007.11.009. Epub 2008 Jan 29.
PubMed 18234457
BOOST-II Australia and United Kingdom Collaborative Groups; Tarnow-Mordi W, Stenson B, Kirby A, Juszczak E, Donoghoe M, Deshpande S, Morley C, King A, Doyle LW, Fleck BW, Davis PG, Halliday HL, Hague W, Cairns P, Darlow BA, Fielder AR, Gebski V, Marlow N, Simmer K, Tin W, Ghadge A, Williams C, Keech A, Wardle SP, Kecskes Z, Kluckow M, Gole G, Evans N, Malcolm G, Luig M, Wright I, Stack J, Tan K, Pritchard M, Gray PH, Morris S, Headley B, Dargaville P, Simes RJ, Brocklehurst P. Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants. N Engl J Med. 2016 Feb 25;374(8):749-60. doi: 10.1056/NEJMoa1514212. Epub 2016 Feb 10.
PubMed 26863265
Askie LM, Darlow BA, Finer N, Schmidt B, Stenson B, Tarnow-Mordi W, Davis PG, Carlo WA, Brocklehurst P, Davies LC, Das A, Rich W, Gantz MG, Roberts RS, Whyte RK, Costantini L, Poets C, Asztalos E, Battin M, Halliday HL, Marlow N, Tin W, King A, Juszczak E, Morley CJ, Doyle LW, Gebski V, Hunter KE, Simes RJ; Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration. Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA. 2018 Jun 5;319(21):2190-2201. doi: 10.1001/jama.2018.5725.
PubMed 29872859
Sink DW, Hope SA, Hagadorn JI. Nurse:patient ratio and achievement of oxygen saturation goals in premature infants. Arch Dis Child Fetal Neonatal Ed. 2011 Mar;96(2):F93-8. doi: 10.1136/adc.2009.178616. Epub 2010 Oct 30.
PubMed 21037284
Gantz MG, Carlo WA, Finer NN, Rich W, Faix RG, Yoder BA, Walsh MC, Newman NS, Laptook A, Schibler K, Das A, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Achieved oxygen saturations and retinopathy of prematurity in extreme preterms. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):138-144. doi: 10.1136/archdischild-2018-316464. Epub 2019 Jun 22.
PubMed 31229956
Hagadorn 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 17015549
Walker PJB, Bakare AA, Ayede AI, Oluwafemi RO, Olubosede OA, Olafimihan IV, Tan K, Duke T, Falade AG, Graham H. Using intermittent pulse oximetry to guide neonatal oxygen therapy in a low-resource context. Arch Dis Child Fetal Neonatal Ed. 2020 May;105(3):316-321. doi: 10.1136/archdischild-2019-317630. Epub 2019 Aug 28.
PubMed 31462405
Sturrock S, Williams E, Dassios T, Greenough A. Closed loop automated oxygen control in neonates-A review. Acta Paediatr. 2020 May;109(5):914-922. doi: 10.1111/apa.15089. Epub 2019 Nov 27.
PubMed 31715041
Mitra S, Singh B, El-Naggar W, McMillan DD. Automated versus manual control of inspired oxygen to target oxygen saturation in preterm infants: a systematic review and meta-analysis. J Perinatol. 2018 Apr;38(4):351-360. doi: 10.1038/s41372-017-0037-z. Epub 2018 Jan 2.
PubMed 29296004
Dargaville PA, Marshall AP, McLeod L, Salverda HH, Te Pas AB, Gale TJ. Automation of oxygen titration in preterm infants: Current evidence and future challenges. Early Hum Dev. 2021 Nov;162:105462. doi: 10.1016/j.earlhumdev.2021.105462. Epub 2021 Sep 4.
PubMed 34511288
Salverda 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 34112721
Plottier GK, Wheeler KI, Ali SK, Fathabadi OS, Jayakar R, Gale TJ, Dargaville PA. Clinical evaluation of a novel adaptive algorithm for automated control of oxygen therapy in preterm infants on non-invasive respiratory support. Arch Dis Child Fetal Neonatal Ed. 2017 Jan;102(1):F37-F43. doi: 10.1136/archdischild-2016-310647. Epub 2016 Aug 29.
PubMed 27573518
Dargaville 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 27634820

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Not yet recruiting
Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells - Intensive Care Unit
Glucose, Metabolism
Not yet recruitingPhase 4
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Infant, Premature, Intubation, Intratracheal

All Neonatal Respiratory Distress Related Conditions trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Automated Oxygen Control for Preterm Infants On Continuous Positive Airway Pressure (CPAP): Phase 1/2 Trial In Southwest Nigeria
ClinicalTrials.gov ID: NCT05508308
Acronym / sponsor ID: HREC84704
Conditions: Neonatal Respiratory Distress Related Conditions, Neonatal Respiratory Failure, Prematurity, Oxygen Toxicity
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Murdoch Childrens Research InstituteUniversity, hospital or other
Collaborators: University of Tasmania, University College Hospital, Ibadan, Sacred Heart Hospital Lantoro, University of Ibadan
Study start: 13 Sep 2022 (actual)
Primary completion: 29 Sep 2023 (actual)
Study completion: 29 Sep 2023 (actual)
First posted: 19 Aug 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: Preterm infants on bCPAP are managed with each mode of oxygen control for 24 hours, prior to crossing over to the other mode of control. Change over simply involves flicking the computer switch from manual to automated control (or vice versa) and it is enacted immediately. It does not require any adjustment or interruption of the CPAP and it does not involve additional action from clinical staff. While the fraction of inspired oxygen (FiO2) adjustments have their effect relatively rapidly, we will apply a 1 h washout period (dropping this data from analysis) to avoid contamination between arms.

Arm	Type	Receives
Manual oxygen control	Active comparator	Other: Manual oxygen controlOxygen therapy delivered with bCPAP as per standard practice, except for the addition of continuous pulse oximetry. Nursing staff will make manual adjustments to Fraction of Inspired Oxygen (FiO2) provided to infants on bCPAP. Oxygen saturations (SpO2) will be monitored by continuous pulse oximetry, and nurses asked to target the range of SpO2 91-95%. Pulse oximeter alarms will be set to alert nurses to periods of hypoxaemia (SpO2<88%) and hyperoxaemia (SpO2>96%).
OxyMate Automated Oxygen Control	Experimental	Device: OxyMateAutomated control of oxygen therapy partnered with bCPAP delivered as per standard practice. The automated oxygen control set-up (OxyMate) will consist of: continuous pulse oximetry input, a computer algorithm (VDL1.1) that calculates changes to delivered FiO2 based on the input SpO2, and a mechanism to automatically effect changes to delivered FiO2. The system will target an SpO2 of 93% (mid-point of the target range). There will be several embedded safety mechanisms, including the ability to manually over-ride OxyMate at any stage. Pulse oximeter alarms will be as for the manual control arm, with additional automated system alarms in place.

Who may qualify

Ages: 12 hours to 1 month
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

<34 weeks gestation (or birth weight < 2kg if gestation not known)
≥12 hours old
Receiving CPAP support and supplemental oxygen (FiO2 >0.21) for respiratory insufficiency
Projected requirement for CPAP and oxygen therapy for > 48 hours

Key exclusion criteria (4 listed)

Deemed likely to fail CPAP in the next 48 hours
Deemed clinically unstable or recommended for palliation by treating team
Cause of hypoxaemia likely to be non-respiratory - e.g. cyanotic heart disease
Informed consent from parent/guardians not obtained

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
OxyMateAutomated Oxygen Control algorithm (VDL 1.1) coupled with Diamedica Baby CPAP device	Device	OxyMate Automated Oxygen Control
Manual oxygen controlGuidelines and training in FiO2 titration to achieve a target range of SpO2. Health workers instructed in responding to continuous pulse oximetry readings and alarms	Other	Manual oxygen control

Primary outcome

Proportion of time in target SpO2 range
Time frame: Measured for each 24 hour study epoch
Proportion of time (over total recorded time) in the target SpO2 range (91-95%, or 91-100% when in room air). Measured as %time

20 secondary outcomes

Proportion of time in target SpO2 range when receiving supplemental oxygen
Time frame: Measured for each 24 hour study epoch
Proportion of time in hypoxaemia
Time frame: Measured for each 24 hour study epoch
Proportion of time in severe hypoxaemia
Time frame: Measured for each 24 hour study epoch
Frequency of prolonged hypoxaemia episodes
Time frame: Measured for each 24 hour study epoch
Proportion of time in hyperoxaemia
Time frame: Measured for each 24 hour study epoch
Proportion of time in severe hyperoxaemia
Time frame: Measured for each 24 hour study epoch
Frequency of prolonged hyperoxaemia episodes
Time frame: Measured for each 24 hour study epoch
Manual FiO2 adjustments
Time frame: Measured for each 24 hour study epoch
No response to prolonged severe hypoxaemia (frequency)
Time frame: Measured for each 24 hour study epoch
No response to prolonged severe hypoxaemia (duration)
Time frame: Measured for each 24 hour study epoch
Severe hypoxaemia with bradycardia (frequency)
Time frame: Measured for each 24 hour study epoch
Severe hypoxaemia with bradycardia (duration)
Time frame: Measured for each 24 hour study epoch
Device malfunction
Time frame: Measured through to OxyMate study completion: estimated 20 weeks
Acceptability and usability
Time frame: Completed for each participant (health workers) at end of an infant's study period (49 hours). Results recorded for unique health workers through to OxyMate study completion: estimated 20 weeks
Costs
Time frame: Measured at completion of OxyMate study: an estimated 20 weeks
Duration of CPAP and oxygen therapy
Time frame: Completed for each participant at end of their study period: 49 hours from study commencement
CPAP in room air
Time frame: Completed for each participant at end of their study period: 49 hours from study commencement
Time on low flow oxygen
Time frame: Completed for each participant at end of their study period: 49 hours from study commencement
Final discharge outcome
Time frame: Up to 4 weeks post enrollment
Length of stay
Time frame: Up to 4 weeks post enrollment

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 13 Nov 2023.
Results publication: PubMed 30389451Chawanpaiboon S, Vogel JP, Moller AB, Lumbiganon P, Petzold M, Hogan D, Landoulsi S, Jampathong N, Kongwattanakul K, Laopaiboon M, Lewis C, Rattanakanokchai S, Teng DN, Thinkhamrop J, Watananirun K, Zhang J, Zhou W, Gulmezoglu AM. Global, regional, and national estimates of levels of preterm birth in 2014: a systematic review and modelling analysis. Lancet Glob Health. 2019 Jan;7(1):e37-e46. doi: 10.1016/S2214-109X(18)30451-0. Epub 2018 Oct 30.
Results publication: PubMed 26447264WHO Recommendations on Interventions to Improve Preterm Birth Outcomes. Geneva: World Health Organization; 2015. Available from http://www.ncbi.nlm.nih.gov/books/NBK321160/
Results publication: PubMed 18234457Gilbert C. Retinopathy of prematurity: a global perspective of the epidemics, population of babies at risk and implications for control. Early Hum Dev. 2008 Feb;84(2):77-82. doi: 10.1016/j.earlhumdev.2007.11.009. Epub 2008 Jan 29.
Results publication: PubMed 26863265BOOST-II Australia and United Kingdom Collaborative Groups; Tarnow-Mordi W, Stenson B, Kirby A, Juszczak E, Donoghoe M, Deshpande S, Morley C, King A, Doyle LW, Fleck BW, Davis PG, Halliday HL, Hague W, Cairns P, Darlow BA, Fielder AR, Gebski V, Marlow N, Simmer K, Tin W, Ghadge A, Williams C, Keech A, Wardle SP, Kecskes Z, Kluckow M, Gole G, Evans N, Malcolm G, Luig M, Wright I, Stack J, Tan K, Pritchard M, Gray PH, Morris S, Headley B, Dargaville P, Simes RJ, Brocklehurst P. Outcomes of Two Trials of Oxygen-Saturation Targets in Preterm Infants. N Engl J Med. 2016 Feb 25;374(8):749-60. doi: 10.1056/NEJMoa1514212. Epub 2016 Feb 10.
Results publication: PubMed 29872859Askie LM, Darlow BA, Finer N, Schmidt B, Stenson B, Tarnow-Mordi W, Davis PG, Carlo WA, Brocklehurst P, Davies LC, Das A, Rich W, Gantz MG, Roberts RS, Whyte RK, Costantini L, Poets C, Asztalos E, Battin M, Halliday HL, Marlow N, Tin W, King A, Juszczak E, Morley CJ, Doyle LW, Gebski V, Hunter KE, Simes RJ; Neonatal Oxygenation Prospective Meta-analysis (NeOProM) Collaboration. Association Between Oxygen Saturation Targeting and Death or Disability in Extremely Preterm Infants in the Neonatal Oxygenation Prospective Meta-analysis Collaboration. JAMA. 2018 Jun 5;319(21):2190-2201. doi: 10.1001/jama.2018.5725.
Results publication: PubMed 21037284Sink DW, Hope SA, Hagadorn JI. Nurse:patient ratio and achievement of oxygen saturation goals in premature infants. Arch Dis Child Fetal Neonatal Ed. 2011 Mar;96(2):F93-8. doi: 10.1136/adc.2009.178616. Epub 2010 Oct 30.
Results publication: PubMed 31229956Gantz MG, Carlo WA, Finer NN, Rich W, Faix RG, Yoder BA, Walsh MC, Newman NS, Laptook A, Schibler K, Das A, Higgins RD; SUPPORT Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Achieved oxygen saturations and retinopathy of prematurity in extreme preterms. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):138-144. doi: 10.1136/archdischild-2018-316464. Epub 2019 Jun 22.
Results publication: 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.
Results publication: PubMed 31462405Walker PJB, Bakare AA, Ayede AI, Oluwafemi RO, Olubosede OA, Olafimihan IV, Tan K, Duke T, Falade AG, Graham H. Using intermittent pulse oximetry to guide neonatal oxygen therapy in a low-resource context. Arch Dis Child Fetal Neonatal Ed. 2020 May;105(3):316-321. doi: 10.1136/archdischild-2019-317630. Epub 2019 Aug 28.
Results publication: PubMed 31715041Sturrock S, Williams E, Dassios T, Greenough A. Closed loop automated oxygen control in neonates-A review. Acta Paediatr. 2020 May;109(5):914-922. doi: 10.1111/apa.15089. Epub 2019 Nov 27.
Results publication: PubMed 29296004Mitra S, Singh B, El-Naggar W, McMillan DD. Automated versus manual control of inspired oxygen to target oxygen saturation in preterm infants: a systematic review and meta-analysis. J Perinatol. 2018 Apr;38(4):351-360. doi: 10.1038/s41372-017-0037-z. Epub 2018 Jan 2.
Results publication: PubMed 34511288Dargaville PA, Marshall AP, McLeod L, Salverda HH, Te Pas AB, Gale TJ. Automation of oxygen titration in preterm infants: Current evidence and future challenges. Early Hum Dev. 2021 Nov;162:105462. doi: 10.1016/j.earlhumdev.2021.105462. Epub 2021 Sep 4.
Individual participant dataSharing planned: Yes. The de-identified data set collected for the final analysis of the OxyMate trial will be available two months after publication of the primary outcome. Documents that will be made available are Study Protocol and Informed Consent Form. Data may be obtained from the Murdoch Children's Research Institute (MCRI) by emailing hamish.graham@mcri.edu.au and mctc@mcri.edu.au

Related trials for Neonatal Respiratory Distress Related Conditions

Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Not yet recruiting
Tracing Of Real-time glu13Cose Metabolism in Human Immune Cells - Intensive Care Unit
Glucose, Metabolism
Not yet recruitingPhase 4
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Infant, Premature, Intubation, Intratracheal

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.

Hamish R Graham, PhD principal investigator

Murdoch Childrens Research Institute

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OxyMate in people with Neonatal Respiratory Distress Related Conditions and Neonatal Respiratory Failure, run by Murdoch Childrens Research Institute at 2 sites in Nigeria.

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 4 inclusion and 4 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 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Nigeria. 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?

Proportion of time in target SpO2 range (time frame: Measured for each 24 hour study epoch). 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 NCT05508308, which also lists 17 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 13 Nov 2023.