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

November 9, 2023 updated by: Murdoch Childrens Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

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 Contact

Study Contact Backup

Study Locations

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

12 hours to 1 month (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • <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

Exclusion Criteria:

  • 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

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
Active Comparator: Manual oxygen control
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%).
Other: Manual oxygen control
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
Experimental: OxyMate Automated Oxygen Control
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.
Device: OxyMate
Automated Oxygen Control algorithm (VDL 1.1) coupled with Diamedica Baby CPAP device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured for each 24 hour study epoch

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of time in target SpO2 range when receiving supplemental oxygen
Time Frame: Measured for each 24 hour study epoch
Proportion of time (over total recorded time) in SpO2 target range (91-95%) when receiving supplemental oxygen. Measured as %time when receiving oxygen
Measured for each 24 hour study epoch
Proportion of time in hypoxaemia
Time Frame: Measured for each 24 hour study epoch
Proportion of time (over total recorded time) with SpO2<90% (hypoxaemia). Measured as %time
Measured for each 24 hour study epoch
Proportion of time in severe hypoxaemia
Time Frame: Measured for each 24 hour study epoch
Proportion of time (over total recorded time) with SpO2 <80% (severe hypoxaemia). Measured as %time
Measured for each 24 hour study epoch
Frequency of prolonged hypoxaemia episodes
Time Frame: Measured for each 24 hour study epoch
Frequency of 30 seconds episodes with SpO2 continuously <80% (severe hypoxaemic episodes). Measured as episodes per hour
Measured for each 24 hour study epoch
Proportion of time in hyperoxaemia
Time Frame: Measured for each 24 hour study epoch
Proportion of time (over total recorded time) with SpO2 >96% when receiving supplemental oxygen (hyperoxaemia). Measured as %time when receiving oxygen
Measured for each 24 hour study epoch
Proportion of time in severe hyperoxaemia
Time Frame: Measured for each 24 hour study epoch
Proportion of time (over total recorded time) with SpO2 >98% when receiving supplemental oxygen (severe hyperoxaemia). Measured as %time when receiving oxygen
Measured for each 24 hour study epoch
Frequency of prolonged hyperoxaemia episodes
Time Frame: Measured for each 24 hour study epoch
Frequency of 30 seconds episodes with SpO2 continuously >96% (hyperoxaemic episodes). Measured as episodes per hour
Measured for each 24 hour study epoch
Manual FiO2 adjustments
Time Frame: Measured for each 24 hour study epoch
Frequency of manual FiO2 adjustments. Measured as FiO2 adjustments/hour
Measured for each 24 hour study epoch
No response to prolonged severe hypoxaemia (frequency)
Time Frame: Measured for each 24 hour study epoch
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 for each 24 hour study epoch
No response to prolonged severe hypoxaemia (duration)
Time Frame: Measured for each 24 hour study epoch
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 for each 24 hour study epoch
Severe hypoxaemia with bradycardia (frequency)
Time Frame: Measured for each 24 hour study epoch
Number of periods with SpO2 <80% for ≥30 seconds with any bradycardia (heart rate <100 bpm). Measured as episodes per hour
Measured for each 24 hour study epoch
Severe hypoxaemia with bradycardia (duration)
Time Frame: Measured for each 24 hour study epoch
Duration of periods with SpO2 <80% for ≥30 seconds with any bradycardia (heart rate <100 bpm). Measured as mean duration per episode
Measured for each 24 hour study epoch
Device malfunction
Time Frame: Measured through to OxyMate study completion: estimated 20 weeks
Number of OxyMate malfunction events
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
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
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
Total costs of prototype system (Diamedica +/- Automated Oxygen control - OxyMate)
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
Duration of time on CPAP with supplemental oxygen. Measured in hours
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
Duration of time on CPAP in room air. Measured in hours
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
Duration of time on low-flow oxygen therapy. Measured in hours
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
Measured as categorical outcome (died in hospital, discharged well, discharged against medical advice, other)
Up to 4 weeks post enrollment
Length of stay
Time Frame: Up to 4 weeks post enrollment
Measured in days
Up to 4 weeks post enrollment

Collaborators and Investigators

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

Sponsor

Murdoch Childrens Research Institute

Collaborators

University College Hospital, Ibadan
University of Ibadan
University of Tasmania
Sacred Heart Hospital Lantoro

Investigators

  • Principal Investigator: Hamish R Graham, PhD, Murdoch Children's Research Institute

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

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)

September 13, 2022

Primary Completion (Actual)

September 29, 2023

Study Completion (Actual)

September 29, 2023

Study Registration Dates

First Submitted

August 12, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 9, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC84704

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

2 months after publication of the primary outcome.

IPD Sharing Access Criteria

Prior to releasing any data the following are required:

  1. A Data Transfer Agreement must be signed between relevant parties.
  2. The MCRI Sponsorship Committee must review and approve your protocol and statistical analysis plan which must include and describe how the data will be used and analysed.
  3. An Authorship Agreement must be agreed to and signed between relevant parties. The Agreement must include details regarding appropriate recognition. Authorship may not be justifiable but some form of acknowledgment is requested.
  4. Agreement to cover any additional costs relating to the provision of the data.
  5. Evidence of ethics approval or waiver of approval, to be compliant with the data transfer agreement and ethics requirement at MCRI.

Data will only be shared with a recognised research institution where the MCRI Sponsorship Committee has approved the proposed analysis plan.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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