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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Automated Oxygen Control algorithm (VDL 1.1) coupled with Diamedica Baby CPAP device
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
Sacred Heart Hospital
Lantoro, Abeokuta, Nigeria
University College Hospital
Agodi, Ibadan, Nigeria
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
Time frame: Measured for each 24 hour study epoch
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured for each 24 hour study epoch
Manual FiO2 adjustments
Frequency of manual FiO2 adjustments. Measured as FiO2 adjustments/hour
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Measured for each 24 hour study epoch
Device malfunction
Number of OxyMate malfunction events
Time frame: 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
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
Total costs of prototype system (Diamedica +/- Automated Oxygen control - OxyMate)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Up to 4 weeks post enrollment
Length of stay
Measured in days
Time frame: Up to 4 weeks post enrollment
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