These trials are currently recruiting in sites across New Zealand. The ON TRACK Network aims to support these trials and promotes engagement across sites. There are still opportunities to join these trials, if you would like to become involved please use the contact details supplied for each trial.

Many of these trials have additional cohort studies which include longer term outcome follow-up studies.


C*STEROID Feasibility

The C*STEROID trial was first developed at an ON TRACK Network Trial Development Workshop in 2017. The trial aims to look at the potential benefits and/or harms of corticosteroid use before planned caesarean section from 35+0 to 39+6 weeks by measuring effects on neonatal respiratory morbidly and hypoglycemia. A very large trial is needed to fully explore these effects. While funding is sought for this, the investigators are undertaking the C*STEROID Feasibility Study to gather more information to conduct a larger network trial. The C*STEROID Feasibility Study will take place at Auckland City Hospital and Tauranga Hospital over a 12 month period.

Recruiting sites: Auckland & Tauranga

Contact for information: laura.mackay@auckland.ac.nz (Trial Manager)


The Diamond Trial

This randomised multi-factorial trial examines the role of different feeding strategies; parenteral nutrition, supplementary milk feeds and sensory stimuli (taste and smell), in infants born moderate- to late-preterm (32-36 weeks gestation) whilst waiting for full enteral nutrition with their mother’s own milk to be established to optimise their growth, metabolic outcomes and development. This trial has been endorsed by the PSANZ IMPACT Network.

Trial Registration: ACTRN12616001199404
Trial website: https://impact.psanz.com.au/clinical-trials/trial-information/
Recruiting Sites: Middlemore, Auckland City, Waitakere and North Shore Hospitals
Contact for information: Tanith Alexander: t.alexander@auckland.ac.nz


The GEMS Study

This randomised trial will determine how gestational diabetes mellitus should be diagnosed by comparing two different blood glucose threshold criteria. The trial is recruiting 9000 women in the Auckland region who are pregnant with one baby and less than 34 weeks with no pre-existing diabetes or history of gestational diabetes.

Trial Registration: ACTRN12615000290594
Trial website: http://www.liggins.auckland.ac.nz/en/for/thecommunity/gems-study.html
Recruiting Sites: Middlemore Hospital, Auckland City Hospital
Contact for information: gems@auckland.ac.nz


LATTE Dosage Trial

Research has led to improvements in neurodevelopmental outcomes for infants born very preterm, but there has been little research on long-term neurodevelopmental outcomes for infants born late preterm. In very preterm infants, both apnoea and intermittent hypoxaemia are common and are associated with worse neurodevelopmental outcomes. Caffeine has been shown to improve intermittent hypoxaemia in very preterm infants, but there are no data to show if this is the case in late preterm infants. This trial is designed to determine the safest and most effective dose of caffeine in late preterm infants before wider studies to investigate the effects of caffeine on neurodevelopment in this group can be initiated.

Trial Registration: ACTRN12618001745235
Recruiting Sites: Auckland City Hospital and Middlemore Hospital
Contact for information: s.philipsen@auckland.ac.nz (Clinical Trial Coordinator)


OBLIGE Induction of Labour Trial

This trial is designed to demonstrate clinical effectiveness, safety and cost effectiveness for mothers and babies who are allowed to go home after commencing induction of labour with balloon, versus remaining in hospital after commencing induction of labour with prostaglandin gel. Most women planning induction of labour at 37 weeks or more with a healthy baby would be suitable to participate.

Trial Registration: ACTRN12616000739415
Trial website: https://oblige.auckland.ac.nz/
Recruiting Sites: Auckland, Hawke's Bay, Hutt Valley, North Shore, Taranaki, Tauranga, Waikato, Waitakere, Wellington, Whakatane
Contact for information: oblige.study@auckland.ac.nz 


The PAEAN Trial

This is a randomised placebo-controlled trial comparing erythropoietin and placebo in term or near term infants (≥35+0 weeks gestation) with hypoxic ischaemic encephalopathy who are receiving, or planned to receive hypothermia. The primary outcome is a composite measure of death or moderate/severe disability.

Trial Registration: ACTRN12614000669695
Trial website: https://ctc.usyd.edu.au/public-trial-pages/paean/about-paean.aspx
Recruiting Sites: Auckland City, Middlemore, Waikato
Contact for information: paean@ctc.usyd.edu.au


PIPPA TAMARIKI

Asthma is one of the most common childhood illnesses in New Zealand, affecting thousands of children each year. Many of these children go on to have life-long asthma and other allergic conditions. Despite improvements in medical care, the number of children with asthma remains very high and we do not know why. This trial (Paracetamol and Ibuprofen in Primary Prevention of Asthma) is to determine whether paracetamol compared to ibuprofen for treatment of babies with pain/fever in the first year of life, increases the risk of asthma at 6 years of age.

Trial Registration: ACTRN12618000303246
Trial website: https://pippatamariki.ac.nz/
Recruiting Sites: Auckland City, Middlemore, and Wellington Hospitals
Contact for information:

Wellington Hospital
Phone: 0800 PIPPA T (0800 747 728) or 027 292 0705
Email: pippatamarikiwgtn@mrinz.ac.nz

Middlemore Hospital
Phone: 0800 PIPPA T (0800 747 728)
Email: pippatamariki@auckland.ac.nz

Auckland City Hospital
Phone: 0800 PIPPA T (0800 747 728)
Email: pippatamariki@adhb.govt.nz


PLUSS Trial

Bronchopulmonary dysplasia (BPD) remains the most common chronic lung disease of infancy, with adverse effects on the lungs and neurodevelopment extending to adulthood. Despite many advances in perinatal care, the incidence of BPD remains unchanged. Early and persistent inflammation of the developing lung contributes to the evolution of BPD and early therapeutic interventions to interrupt the inflammatory process may be beneficial. The PLUSS trial is a multicentre, two-arm, parallel, double-blind, randomised controlled trial. It is designed to answer if in extremely preterm infants does surfactant and budesonide given via the trachea compared with surfactant alone, increase survival free of BPD?

Trial Registration: ACTRN12617000322336
Recruiting Sites: Middlemore Hospital and Auckland City Hospital
Contact for information: pluss@thewomens.org.au


PROTECT Trial

Very preterm infants are at risk of developing bacterial blood infections (sepsis) and/or bowel inflammation called Necrotizing EnteroColitis (NEC). Both sepsis and NEC cause harmful inflammation, which can lead to brain injury and increase the risk of disability. Currently sepsis and NEC are treated with antibiotics, supportive care and surgery in some NEC cases, however there is no treatment for reducing the harmful inflammation. Small studies have shown that giving Pentoxifylline, a safe and well tolerated drug, as an adjunct therapy to standard of care during sepsis and NEC may reduce mortality in this vulnerable population of infants. The aim of PROTECT study is to determine if Pentoxifylline plus standard treatment of care in babies born less than 29 weeks gestation with sepsis or NEC improves survival without disability.

Trial Registration: ACTRN12616000405415
Trial website: https://www.ctc.usyd.edu.au/our-research/clinical-trials/neonatal/active-trials.aspx
New Zealand recruiting sites: Auckland, Christchurch, Wellington
Contact for information: protect@ctc.usyd.edu.au