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PROTECT Me: Assessing Antenatal Maternal Melatonin Supplementation in Fetal Growth Restriction to Improve Neurodevelopmental Outcomes

  • Palmer, Kirsten (Primary Chief Investigator (PCI))
  • Wallace, Euan (Chief Investigator (CI))
  • Groom, Katie (Chief Investigator (CI))
  • Mol, Ben (Chief Investigator (CI))
  • Davies, Miranda (Chief Investigator (CI))
  • Fahey, Michael (Chief Investigator (CI))
  • Anderson, Peter (Chief Investigator (CI))
  • Goergen, Stacy (Chief Investigator (CI))
  • Pannek, Kerstin (Chief Investigator (CI))
  • Miller, Suzanne (Chief Investigator (CI))

Project: Research

Project Details

Project Description

Fetal growth restriction (FGR) complicates 1 in 14 Australian pregnancies and over 30 million globally. FGR significantly increases in the risk of stillbirth, preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying subsequent cognitive and behavioural impairment and cerebral palsy. This is the first phase III randomised, placebo-controlled trial assessing the use of melatonin, a cheap and widely available supplement, in pregnancies complicated by early onset FGR to protect the unborn fetal brain and improve subsequent neurodevelopmental outcomes.
Short titleneuroPROTECTion with Melatonin
StatusFinished
Effective start/end date1/01/20 → 31/12/25

Funding

  • NHMRC - National Health and Medical Research Council (Australia): A$1,607,080.60

Keywords

  • melatonin
  • fetal growth restriction
  • neurodevelopment
  • antioxidant therapy
  • neuroimaging

Clinical Trial Phase

  • Phase III (a & b)
  • Sponsor is Monash University