Automated Versus Manual Control Of Oxygen For Preterm Infants On Continuous Positive Airway Pressure In Nigeria
Condition: Neonatal Respiratory Distress Related Conditions; Neonatal Respiratory Failure; Prematurity; Oxygen Toxicity
MeSH terms: Respiratory Insufficiency; Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome
Study type: Interventional

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.
    

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.
    

Intervention name(s): OxyMate; Manual oxygen control
Intervention type(s): Device; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention 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)
Primary purpose: Treatment