Table 1

Standard Protocol Items: Recommendations for Interventional Trials trial data

Data categoryInformation
Primary registry and trial IDAustralian and New Zealand Clinical Trials Registry, ACTRN12617001515381
Date of registration in primary registry30 October 2017
Secondary identifying numbersU1111-1203-6718
Source of funding or material supportCerebral Palsy Alliance, Equity Trustee’s
Primary sponsorMonash Health
Secondary sponsorMonash University
Contact for public queriesKRP (kirsten.palmer@monash.edu)
Contact for scientific queriesKRP (kirsten.palmer@monash.edu)
SLM (suzie.miller@monash.edu)
Public titleMelatonin supplementation to improve neurodevelopment among growth restricted fetuses (PROTECT Me).
Scientific titleA Randomised Controlled Trial of Antenatal Melatonin Supplementation in Fetal Growth Restriction for Fetal Neuroprotection (PROTECT Me)
Protocol version and dateversion 2.1; 27/11/2018
Countries of recruitmentAustralia and New Zealand
Health condition studiedFetal growth restriction
InterventionsMelatonin 30 mg daily (10 mg three times daily) compared with visually identical placebo (no active ingredient).
Key inclusion and exclusion criteriaInclusion criteria: Singleton pregnancy, severe fetal growth restriction, defined as either abdominal circumference ≤3rd centile for gestational age or abdominal circumference <10th centile in combination with at least one abnormal utero-feto-placental Doppler study, confirmed 23+0–31+6 weeks’ gestation, age≥18 years and understands English.
Exclusion criteria: A fetus with a known chromosomal, major structural anomaly or non-placental cause of fetal growth restriction, Pregnancies requiring immediate delivery (eg, absent A wave in ductus venosus, preterminal CTG or biophysical profile) or recruitment in another clinical trial where a pharmaceutical product or nutritional supplement is the trial intervention.
Study typeInterventional
Allocation: Randomisation
Interventional Model: parallel, placebo controlled
Masking: Triple blinded
Phase II
Date of 1st enrolmentNot yet commenced
Target sample size336
Recruitment statusNot yet commenced
Primary outcomeTo determine whether improved cognitive performance on the Bayley-III at 2 years of age is seen among survivors of fetal growth restriction who receive melatonin antenatally compared with those who receive placebo.
Key secondary outcomes1. To determine the impact of melatonin supplementation on fetal growth and well-being.
2. To report the tolerability and occurrence of any adverse and serious adverse events associated with maternal melatonin use.
3. To determine if antenatal exposure to melatonin impacts on neonatal sleep-wake cycles.