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Trial Name Trial ID Main Coordinating Centre
and contact		 Status Recruitment Topic Participants Details
DIAMOND - DIfferent Approaches to MOderate & later preterm Nutrition: Determinants of feed tolerance, body composition and development ACTRN12616001199404 Liggins Institute, University of Auckland
t.alexander@auckland.ac.nz		 Currently recruiting
IMPACT endorsed
 Newborn nutrition Newborn body composition Neurodevelopment Preterm babies between 32+0 - 35+6 admitted to the neonatal unit requiring IV insertion
Effect of position during bottle feeding on physiological stability in preterm infants ACTRN12611000944932 Dr Jennifer Dawson Recruitment complete Newborn nutrition
Efficacy and safety of a novel fish oil based lipid emulsion (SMOFlipid) compared with olive oil based lipid emulsion (Clinoneic) in term and near-term (>34 weeks) neonates - a randomised controlled trial ACTRN12609000337279 Princess Margaret Hospital for Children, WA girish.deshpande@health.wa.gov.au Recruitment complete Newborn nutrition
IFOS - The Infant Fish Oil Supplementation Study ACTRN12606000281594 Princess Margaret Hospital
S J Meldrum		 Recruitment complete Newborn nutrition
Tolerability and safety of olive oil-based lipid emulsion in critically ill neonates: a blinded randomized trial julie.bines@rch.org.au Recruitment complete Newborn nutrition
Selenium status of term infants fed selenium-supplemented formula in a randomized dose-response trial Maria Makrides Recruitment complete Newborn nutrition
TIGGA - Growth and nutritional status of infants fed formula based on goat milk or cow milk ACTRN12608000047392 Child Nutrition Research Women's & Children's Hospital Jo Zhou Recruitment complete Newborn nutrition Healthy term infants, birth weight >=2.5kg & <=4.75kg, mother is exclusively feeding an infant formula within 2 weeks of birth or plans to exclusively breastfeed for at least 4 months.
POPPET - Providing Optimal Protein for Prems via Enteral Tubes. Does increasing the protein content of human milk fortifier improve growth in preterm infants <33 weeks gestation? A randomised controlled trial. ACTRN12611001275954 Women's & Children's Health Research Institute jessica.reid@adelaide.edu.au Recruitment complete Newborn nutrition Infants <33 completed weeks gestation whose mothers intend to provide breast milk
Safety of supplementing infant formula with long-chain polyunsaturated fatty acids and Bifidobacterium lactis in term infants: a randomised controlled trial Women's & Children's Hospital, CYWHS Maria Makrides Recruitment complete Newborn nutrition
InFANT - The Infant Feeding Activity and Nutrition Trial an early intervention to prevent childhood obesity: cluster-randomised controlled trial ISRCTN81847050 Melbourne Dr Karen Campbell Recruitment complete Newborn nutrition
SUPPOSE - Randomised controlled trial of prophylactic glycerol suppositories on gastric emptying and feed tolerance in premature infants Recruitment complete Newborn nutrition
DINO-II pilot study - Determining the docosahexaenoic acid dose to obtain plasma and erythrocyte phospholipid fatty acid profiles in preterm infants comparable to term infant profiles: a dose response pilot study. ACTRN12610000382077 carmel.collins@health.sa.gov.au Recruitment complete Newborn nutrition Infants born less than 33 weeks gestation after one but before five days of commencing any enteral feeds and with parental/guardian consent. Multiple births will be eligible and will be randomised individually. Women providing breast milk for their infant not taking DHA supplements or willing to stop taking supplements for duration study.
ProPrem - The use of probiotics to reduce the incidence of sepsis in premature infants ACTRN12607000144415 Royal Women's Hospital Linh Ung Recruitment complete Newborn infection. Newborn nutrition
INIS - International Neonatal Immunotherapy Study ACTRN012606000273583; NHMRC301973; PTO373 Westmead Hospital, NSW Priya Duggal-Beri Recruitment complete Newborn infection
LOS trial - Prevention of late onset septicemia in infants in the neonatal intensive care unit, Mater Mothers' Hospital. PT0363 Mater Mothers' Hospital, Brisbane Helen Liley Recruitment complete Newborn infection
A randomised control trial (RCT) of enhanced parenting to improve developmental outcomes in preterm infants ACTRN12612000194864 University of Queensland
p.colditz@uq.edu.au		 Currently recruiting Newborn developmental. Parenting
Randomised control trial comparing the use of the Neobar endotracheal tube holder with standard taping technique for nasal intubation in the newborn infant Kristen James Recruitment complete Newborn cardiovascular
DETECT - Targeting of treatment of the patent ductus arteriosus using early echocardiography ACTRN12608000295347 martin.kluckow@sydney.edu.au Recruitment complete Newborn cardiovascular
Randomised trial of dopamine vs dobutamine for treatment of low systemic blood flow in very preterm infants ACTRN12607000152426 Nick Evans Recruitment complete Newborn cardiovascular
Targeting duration of indomethacin treatment to the PDA constrictive response using echocardiography: a randomised controlled trial Recruitment complete Newborn cardiovascular
OPIO - Optimising preterm infant outcomes: a RCT to evaluate two screening & surveillance methods PT0518/ACTRN012606000472572 Margo Pritchard Recruitment complete Newborn ? developmental
MAGENTA - Does antenatal magnesium sulphate given to women at risk of preterm birth between 30 and 34 weeks' gestation reduce the risk of death or cerebral palsy in their children? - a randomised controlled trial. ACTRN126110000491965 University of Adelaide, Clinical Trial Manager Pat Ashwood +61 8 8161 7767
 Currently recruiting
IMPACT reviewed
 Neuroprotection, Antenatal magnesium sulphate, Cerebral palsy
 Women at risk of preterm birth between 30 and 34 weeks’ gestation where birth is planned or definitely expected within 24 hours, have a singleton or twin pregnancy, no contraindications to the use of antenatal magnesium sulphate
HUNTER trial - High-flow nasal cannulae use in non-tertiary centres for early respiratory distress in newborn infants ACTRN12614001203640 Dr Brett Manley, Newborn Research Centre, The Royal Women's Hospital, Parkville, VIC Currently recruiting Neonatology, Respiratory Distress, Preterm Infants, CPAP
 Preterm and term infants admitted to non-tertiary nurseries with respiratory distress
HINT 2 - Hyperglycaemia in Neonates Trial. Computer determined insulin dosage in the management of neonatal hyperglycaemia ACTRN12614000492651 University of Auckland; Department of Paediatrics: Child and Youth Health, Jane Alsweiler, j.alsweiler@auckland.ac.nz Currently recruiting Neonatal hyperglycaemia, Insulin
 Extremely preterm babies with neonatal hyperglycaemia
Help-seeking for postnatal depression as a major public health problem: A cluster randomised controlled trial of motivational interviewing ACTRN12611000635965 Parent-Infant Research Institute, Austin Health, (03) 9496 4496, piri@austin.org.au
 Recruitment complete Motivational interviewing, postnatal depression Women with a 4-week old baby
OPRA - Outpatient cervical priming for induction of labour ACTRN12608000249358 Women's and Children's Hospital chrisswilkinson@mac.com Recruitment complete Models of care. Labour and intrapartum care Pregnant women having priming for induction of labour, where induction is clinically indicated, there is no evidence of maternal or fetal compromise and in the opinion of the referring caregiver, outpatient management and monitoring is clinically appropriate
MANGO - A randomised controlled trial of caseload midwifery ACTRN12609000349246 UTS Recruitment complete Models of care. Pregnant women will be eligible if they are: 18 years of age or older, at 24 weeks of gestation, currently experiencing a mood disorder and have a Edinburgh Postnatal Depression Scale (EPDS) scores of greater than or equal to 13.
COSMOS - Caseload midwifery for women at low risk of medical complications: a randomised controlled trial ACTRN12607000073404 Royal Women's Hospital Helen McLachlan Recruitment complete Models of care
EECV2 - Early external cephalic version 2 trial PT0542/ISRCTN56498577 McMaster, Canada Eileen Hutton Recruitment complete Models of care
OPTIMIST-A - Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation on continuous positive airway pressure ACTRN12611000916943 : NCT02140580 Menzies Institute, UTAS (optimist.trial@utas.edu.au) Currently recruiting Minimally-invasive surfactant therapy, preterm infant, respiratory distress syndrome Preterm infants 25-28 weeks gestation on CPAP
The effects of mindfulness training on maternal stress, depressed mood and present moment awareness: A pilot randomised trial ACTRN12614000523606 Monash University jill.beattie@monash.edu Recruitment complete Mindfulness, Pregnancy, Randomised trial Low risk pregnancy in the second trimester at the start of the intervention; 18 years or older; able to read and speak English; having a planned hospital birth; and who commit to attending all eight sessions.
The DOMInO Trial - Randomised Trial of DHA in pregnancy to prevent postnatal depressive symptoms and enhance neurodevelopment in children ACTRN12611001125910/NHMRC 349301 Children, Youth and Women's Health Services, SA Suzanne McCusker Recruitment complete Maternal nutrition. Parental social and emotional wellbeing Children who were included in the secondary outcome (neurodevelopment at 18months as assessed by the BSIDIII) of the original DOMInO Trial
GI Baby 3 - A dietary intervention during pregnancy to reduce child obesity ACTRN12610000681055 The University of Sydney Dawn Tan Recruitment complete Maternal nutrition. Obesity
EASI - Efficacy and side effects of iron supplements for the correction of anaemia in pregnant women: a comparison of high dose vs low dose iron PT0538 / ACTRN12606000357550 WCH Maria Makrides Recruitment complete Maternal nutrition. Maternal medical conditions Pregnant women with anaemia on routine screening test at the end of 2nd trimester
The effect of a low glycemic index diet during pregnancy on obstetric outcomes JC Brand Miller Recruitment complete Maternal nutrition
AMBIT - Australian Mothers and Babies Iron Trial NHMRC250431 Maria Makrides Recruitment complete Maternal nutrition
DHAllergy - Fish oil supplementation in pregnancy to reduce allergies in early childhood ACTRN12610000735055 Child Nutrition Research Centre, Women's & Children's Health Research Inst, WCH Debbie Palmer Recruitment complete Maternal nutrition Child to have a family history of medically diagnosed allergic disease (eczema, asthma, allergic rhinitis): singleton pregnancy less than 18-21 weeks gestation with no known fetal abnormality: mothers not to have had documented history of alcohol or drug abuse: no participation in other clinical trials with fatty acid intervention.
PREGGIO - Pregnancy and Glycaemic Index Outcomes Study comparing a low glycaemic index (GI) diet to a standard healthy diet ACTRN12610000174088 Clinical Trials & Research Unit South East Sydney & Illwarra Area Health Service Diabetes Centre Shelly Charters Recruitment complete Maternal nutrition
Effect of maternal egg consumption on breast milk ovalbumin concentration Women's & Children's Hospital Recruitment complete Maternal nutrition
A prospective randomised trial to study the effect of intravenous iron therapy versus the standard treatment with oral iron for women diagnosed with iron deficiency anaemia in pregnancy ACTRN12609000177257 Launceston General Hospital
joanne.bates@dhhs.tas.gov.au		 Recruitment complete Maternal nutrition At risk women - dark skinned, veiled, Anyone with vitamin D deficiency that has not commenced treatment prior to recruitment
A randomised controlled trial on the effects of antenatal vitamin D supplementation to improve vitamin D levels in the maternal and cord blood at birth in vitamin D deficient pregnant women ACTRN12609000142235 Monash Medical Centre Recruitment complete Maternal nutrition
BEAR - An effect of antenatal and postanatal maternal support programs on attachment and resilience for mums and infants: A randomised controlled trial ACTRN12615000684527 Centre for Women’s Mental Health, RWH – Dr Angela Komiti (Project Coordinator): angelaak@unimelb.edu.au Currently recruiting Maternal mental health; early intervention; attachment Pregnant women referred for mental health services at RWH
A randomised controlled trial evaluating the effectiveness of a nurse-moderated group-based internet support program for mothers with comorbid mild to moderate depression and parenting problems ACTRN12616001732471 Research &amp, Dept Paediatrics, University of Adelaide, South Australia 5006
Prof Michael Sawyer
michael.sawyer@adelaide.edu.au		 Not yet recruiting Maternal mental health, support Postnatal women
A micronutrient intervention for pregnant women experiencing symptoms of depression and anxiety ACTRN12617000354381 Mental Health and Nutrition Research Group, Department of Psychology, University of Canterbury, Christchurch 8140
Prof Julia Rucklidge
julia.rucklidge@canterbury.ac.nz		 Currently recruiting Maternal mental health, micronutrients Pregnant women
Integrated e-Screening for Postnatal Depression and Anxiety ACTRN12616001217493 Parent-Infant Research Institute, Heidelberg Repatriation Hospital, VIC 3081
Prof Jeannette Milgrom
jeannette.milgrom@austin.org.au		 Currently recruiting Maternal mental health, postnatal depression screening Pregnant women
CHIPS trial: Control of Hypertension In Pregnancy Study ISRCTN71416914 / NCT01192412 Recruitment complete Maternal medical conditions. Preeclampsia
PRAM - Prospective Randomised Automated versus Mercury blood pressure recordings in hypertensive pregnancy NCT00809666 University of Sydney Lynne Roberts Recruitment complete Maternal medical conditions
Hypnosis for nausea and vomiting in early pregnancy a randomised controlled trial ACTRN12607000127404 Women's and Children's Hospital Alan Cyna alan.cyna@adelaide.edu.au Recruitment complete Maternal medical conditions Pregnant women suffering from nausea and vomiting of pregnancy.
MAMMA -Multidisciplinary Approach to Management of Maternal Asthma ACTRN12612000681853 Mercy Hospital for Women<br>Monash University Johnson.George@monash.edu Recruitment complete Maternal medical conditions
World Maternal Antifibrinolytic Trial (WOMAN) - Tranexamic acid for the treatment of postpartum haemorrhage: an international, randomised, double blind, placebo controlled trial. ISRCTN76912190/ NCT00872469 Clinical Trials Unit, London School of Hygiene and Tropical Medicine
thewomantrial@lshtm.ac.uk, http://www.womantrial.lshtm.ac.uk/
 Recruitment complete Maternal Health, Postpartum Haemorrhage Adult women, after delivery who have clinically diagnosed postpartum haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. 20 060 women were enrolled by the end of the trial.