Study design

International, multicentre, Phase 111, double-blind, randomised controlled trial

Chief Investigator

Amy Plint (Canada), Ed Oakley (Australia), Stuart Dalziel (New Zealand)

Time frame

2019 – 2023

Funding

NHMRC project funding (APP1164946) Cure Kids (NZ), Starship Foundation (NZ), The Perth Children’s Hospital (WA), The Telethon – Perth Children’s Hospital Research Fund (WA)

Site locations

  • Perth Children’s Hospital, Perth, WA, Australia
  • Middlemore Kidz First Hospital, Auckland, New Zealand
  • Monash Medical Centre, Melbourne, Australia
  • Starship Children’s Hospital, Auckland, New Zealand
  • Waikato Hospital, Hamilton, New Zealand
  • Women’s and Children’s Hospital, Adelaide, Australia
  • Children’s Hospital of Eastern Ontario, Ottawa
  • Le Centre hopitalier universitatie Sainte-Justine, Montréal
  • Children’s Hospital of Western Ontario, London
  • Children’s Hospital, Winnipeg
  • Alberta Children’s Hospital, Calgary
  • Stollery Children’s Hospital, Edmonton

Sample

1, 616 children aged > 60 days to < 12months

Clinical trial registrations

www.Clinicaltrials.gov   Project ID: NCT03567473

Contact

ed.oakley@rch.org.au or SDalziel@adhb.govt.nz