[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100489302":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":225,"collaborators":228,"id":236,"slug":237,"hasResults":238,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":242,"eligibilityCriteria":243,"healthyVolunteers":244,"sex":245,"minAge":246,"maxAge":24,"enrollmentInfo":247,"targetDuration":24,"studyType":250,"phases":251,"briefSummary":253,"conditions":254,"keywords":24,"overallStatus":43,"whyStopped":24,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},{"fullName":5,"class":6},"Monash University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Visually identical placebo tablets containing no active ingredient to the active treatment, administered three times a day.",[13],"Other: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Melatonin","ACTIVE_COMPARATOR","10mg Melatonin tablets, administered three times a day (a total daily dose of 30mg per day)",[19],"Drug: Melatonin 10 MG",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Tablets, visually identical to the melatonin tablets, but containing no active ingredient are administered three times a day.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DRUG","Melatonin 10 MG","Melatonin 10 mg tablets will be administered three times a day, up to a maximum of 30 mg daily",[15],[31],{"name":32,"affiliation":33,"role":34},"Kirsten Palmer, PhD","Monash University & Monash Health","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":24,"email":39},"CONTACT","+61 3 9594 5145","kirsten.palmer@monash.edu",[41,60,78,93,107,125,143,157,171,184,200,211],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Royal Prince Alfred","RECRUITING","Camperdown","New South Wales","2050","Australia","AU",{"type":50,"coordinates":51},"Point",[52,53],151.17642,-33.88965,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":24,"email":59},"Sumathi Rajendran","+61 02 9515 6079","sumathirajendran@gmail.com",{"facility":61,"status":43,"city":62,"state":45,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"John Hunter Hospital","Newcastle","2305",{"type":50,"coordinates":65},[66,67],151.7801,-32.92953,{"lat":67,"lon":66},[70,74],{"name":71,"role":37,"phone":72,"phoneExt":24,"email":73},"Craig Pennell, PhD","(0) 421 941 570","Craig.Pennell@newcastle.edu.au",{"name":75,"role":37,"phone":76,"phoneExt":24,"email":77},"Tegan Grace, PhD","02 4042 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293","clarew@unimelb.edu.au",{"facility":172,"status":43,"city":173,"state":128,"zip":174,"country":47,"countryCode":48,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Joan Kirner Hospital","Saint Albans","3021",{"type":50,"coordinates":176},[177,178],144.8,-37.73333,{"lat":178,"lon":177},[181],{"name":182,"role":37,"phone":24,"phoneExt":24,"email":183},"SuLynn Khong","SuLynn.Khong@wh.org.au",{"facility":185,"status":43,"city":186,"state":24,"zip":187,"country":188,"countryCode":189,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Auckland Hospital","Auckland","1023","New Zealand","NZ",{"type":50,"coordinates":191},[192,193],174.76349,-36.84853,{"lat":193,"lon":192},[196],{"name":197,"role":37,"phone":198,"phoneExt":24,"email":199},"Katie Groom","+64 9 923 9823","k.groom@auckland.ac.nz",{"facility":201,"status":43,"city":186,"state":24,"zip":202,"country":188,"countryCode":189,"cosmosGeoPoint":203,"geoPoint":205,"contacts":206},"Middlemore Hospital","2025",{"type":50,"coordinates":204},[192,193],{"lat":193,"lon":192},[207],{"name":208,"role":37,"phone":209,"phoneExt":24,"email":210},"Chris McKinlay","+64 274725099","c.mckinlay@auckland.ac.nz",{"facility":212,"status":43,"city":213,"state":24,"zip":214,"country":188,"countryCode":189,"cosmosGeoPoint":215,"geoPoint":219,"contacts":220},"Wellington Regional Hospital","Wellington","6021",{"type":50,"coordinates":216},[217,218],174.77557,-41.28664,{"lat":218,"lon":217},[221],{"name":222,"role":37,"phone":223,"phoneExt":24,"email":224},"Sally J Gundersen, PhD","+64 4 385 5999","Sally.Gundersen@ccdhb.org.nz",{"type":34,"investigatorFullName":226,"investigatorTitle":227,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Dr Kirsten R. Palmer","Principal Investigator",[229,231,233],{"name":230,"class":6},"National Health and Medical Research Council, Australia",{"name":232,"class":6},"Cerebral Palsy Alliance",{"name":234,"class":235},"Equity Trustees","UNKNOWN","100489302","phase-3-antenatal-melatonin-supplementation-for-neuroprotection-in-fetal-growth-restriction-100489302",false,"NCT05651347","Antenatal Melatonin Supplementation for Neuroprotection in Fetal Growth Restriction","A Triple-blinded, Randomized, Parallel-group Placebo-controlled Trial to Assess the Impact of Maternal Antenatal Melatonin Supplementation on Early Childhood Neurodevelopmental Outcomes in the Setting of Severe Preterm Fetal Growth Restriction","PROTECTMe","Inclusion Criteria:\n\n1. Singleton Pregnancy\n2. Severe fetal growth restriction, defined as:\n\n   * Abdominal circumference ≤3rd centile for gestational age according to charts supplied that have been adapted from Westerway et al; or\n   * Abdominal circumference \\\u003C10th centile in combination with at least one abnormal fetoplacental Doppler study, being:\n\n     * Uterine artery (raised pulsatility index ≥95th centile)\n     * Umbilical artery (pulsatility index ≥95th centile or absent\u002Freversed end-diastolic flow)\n3. Confirmed 23+0 - 31+6 weeks' gestation\n4. Age ≥18 years\n5. Understand English\n\nExclusion Criteria:\n\n1. A fetus with a known chromosomal, major structural anomaly or non-placental cause of fetal growth restriction\n2. Pregnancies requiring immediate delivery (e.g. absent A wave in ductus venosus, preterminal CTG or biophysical profile)\n3. Co-recruitment in another clinical trial where a pharmaceutical product or nutritional supplement impacting on oxidative stress is the trial intervention.\n4. Currently prescribed Fluvoxamine",true,"FEMALE","18 Years",{"count":248,"type":249},336,"ESTIMATED","INTERVENTIONAL",[252],"PHASE3","Fetal growth restriction (FGR) is a significant health care issue, affecting 20,000 Australian pregnancies every year. Undetected FGR is one of the key risk factors for stillbirth, but FGR can also cause significant impairments in short and long-term health outcomes for the child.\n\nIt is a major risk factor for preterm birth and is a recognised causal pathway to the neurodevelopmental injury underlying cognitive and behavioural impairment and cerebral palsy. Current obstetric care is focused on the detection of the growth restricted fetus and then ultrasound assessment of fetal wellbeing to guide timing of delivery. This approach seeks to maximize the gestational age of the fetus at delivery to minimise the risks of prematurity, while delivering the fetus in time to reduce the likelihood of stillbirth. Currently, no therapies exist that can maximize fetal wellbeing in the setting of growth restriction and minimise the frequency of antenatally acquired brain injury due to in-utero hypoxia.\n\nThis triple-blind, randomized, parallel group, placebo-controlled trial will administer maternal melatonin or placebo supplementation antenatally in the setting of early-onset severe FGR to determine whether melatonin can PROTECT the fetal brain and lead to improved neurodevelopmental outcomes.",[255,256,257],"Fetal Growth Retardation","Stillbirth and Fetal Death","Pregnancy Preterm","2025-06-03",{"date":260,"type":261},"2025-06-06","ACTUAL",{"date":263,"type":261},"2019-05-29",{"date":265,"type":249},"2027-04-30",{"name":5,"class":6},12]