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

Summary

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.

Conditions

• Neonatal Respiratory Distress Related Conditions
• Neonatal Respiratory Failure
• Prematurity
• Oxygen Toxicity

Interventions

DEVICE

OxyMate

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

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

Sponsors & Collaborators

• University of Tasmania

  collaborator OTHER

• University College Hospital, Ibadan

  collaborator OTHER

• Sacred Heart Hospital Lantoro

  collaborator UNKNOWN

• University of Ibadan

  collaborator OTHER

• Murdoch Childrens Research Institute

  lead OTHER

Principal Investigators

• Hamish R Graham, PhD · Murdoch Childrens Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

12 Hours

Max Age

1 Month

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-09-13

Primary Completion

2023-09-29

Completion

2023-09-29

Countries

• Nigeria