A Multi - Disciplinary Research Collaboration.

COAST Trial

Children’s Oxygen Administration Strategies Trial (COAST)

COAST is an open, multi-Centre, randomized controlled trial that is currently run by Global Health Uganda in Mulago hospital. There are 3 participating sites in Uganda ie Mulago National Referral Hospital, Mbale Regional Referral Hospital and Soroti Regional Referral Hospital and 2 sites in Kenya.

Our goal is to recruit 4,200 children over a period of 36 months. The children included are aged between 28 days and 12 years with respiratory distress complicated by hypoxia (defined as SaO2 <92%). Children with known uncorrected cyanotic heart disease, chronic lung diseases apart from Asthma and those who receive oxygen before being referred to Mulago are excluded.

The Trial hypotheses include;

  • To establish whether liberal oxygenation for SaO2 ≥80% will decrease mortality (at 48 hours and up to 28 days) compared with a strategy that includes permissive hypoxia (usual care); and
  • To establish whether use of high flow oxygen delivery will decrease mortality (at 48 hours and up to 28 days) compared with low flow oxygen delivery (usual care)

The Trial primary outcome is mortality at 48 hours post-randomization and there are multiple secondary outcomes listed below;

  • Treatment failure at 48 hours
  • Survival to 28 days
  • Neurocognitive sequelae at 28 days
  • Disability-free survival to 28 days
  • Time to hypoxia (≥92%) resolution during initial hospital stay
  • Length of initial hospital stay
  • Re-admission to hospital by 28 days
  • Anthropometric status by 28 days
  • Resolution of neurocognitive sequelae at 90 days (for those with neurocognitive sequelae at 28 days)

The trial has two strata: COAST A: severe hypoxia, SaO2 <80%); and COAST B: hypoxia SaO2 ≥80% and <92%).

Children in COAST A (2-arm, 1:1 ratio) will all receive oxygen and randomization will allocate participants to one of two methods of oxygen delivery:

  1. high flow oxygen delivery
  2. low flow (usual practice) oxygen delivery

 

Children in COAST B (3-arm, 2:1:1 ratio) will be allocated to:

  1. permissive hypoxia (no immediate oxygen): control
  2. high flow oxygen delivery

iii.            low flow oxygen delivery

End of Trial is defined as “Last participant, last follow-up”

The Trial is sponsored by Imperial College London and funded by Joint Global Health Trials scheme (Medical Research Council, Department for International Development and Wellcome Trust)

 

Address

Global Health Uganda
Mawanda Road, Plot 667
P.O BOX 33842, Kampala - Uganda
Tel: +256393516707

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