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Completed

NCT Number: NCT05508308

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

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Key information

Conditions

Neonatal Respiratory Distress Related Conditions Female Urogenital Diseases and Pregnancy Complications Neonatal Respiratory Failure Obstetric Labor Complications Obstetric Labor, Premature Oxygen Toxicity Pregnancy Complications Premature Birth Prematurity Urogenital Diseases

Age range

12 hour–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sacred Heart Hospital, Lantoro, Abeokuta, Nigeria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OxyMate

Device

Automated Oxygen Control algorithm (VDL 1.1) coupled with Diamedica Baby CPAP device

Manual Oxygen Control

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Manual FiO2 adjustments

    Time frame: Measured for each 24 hour study epoch

    Frequency of manual FiO2 adjustments. Measured as FiO2 adjustments/hour

  9. 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

  10. 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

  11. 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

  12. 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

  13. Device malfunction

    Time frame: Measured through to OxyMate study completion: estimated 20 weeks

    Number of OxyMate malfunction events

  14. 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

  15. Costs

    Time frame: Measured at completion of OxyMate study: an estimated 20 weeks

    Total costs of prototype system (Diamedica +/- Automated Oxygen control - OxyMate)

  16. 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

  17. 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

  18. 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

  19. 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)

  20. Length of stay

    Time frame: Up to 4 weeks post enrollment

    Measured in days

Sponsors and collaborators

Lead sponsor

Murdoch Childrens Research Institute

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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