World-first research platform transforming care around babies born too soon

The Health Research Council (HRC) is investing $1.44 million to bring the innovative PLATIPUS research platform to hospitals across Aotearoa.

Led in New Zealand by Professor Katie Groom from the University of Auckland's Liggins Institute, the funding establishes New Zealand as a full partner in the trans-Tasman PLATIPUS (PLatform for Adaptive Trials In Perinatal UnitS) initiative. 

It also supports one of the first PLATIPUS projects, PROMOAT, a clinical trial to determine the best antibiotic treatment for pregnant women whose waters break early.

Preterm birth (being born before 37 weeks gestation) is the leading cause of death in children under five worldwide, and survivors often face lifelong health challenges – from breathing problems to cerebral palsy, hearing and sight difficulties, developmental delay and behavioural issues. 

In New Zealand, around 8 percent of babies are born too soon, and the numbers have risen, not fallen, in the last 10 years. Māori and Pacific babies are more likely to be born preterm, and they are more likely to have a preterm death.

Despite these statistics, Groom says there is a shortage of best-practice clinical evidence to guide the everyday decisions clinicians have to make around the care of pregnant women and their newborns. Research-based evidence could make a real difference to the outcomes for preterm babies.

"There are so many important questions in preterm birth, from how we try to stop it happening, to how we give babies the best possible chance before, during and after birth. Traditionally, every question requires its own clinical trial, making research slow, expensive and difficult."

PLATIPUS changes that, she says, because it is structured as an ongoing clinical research platform where multiple trials, known as domains, can run simultaneously sharing the same infrastructure, participating hospitals, research teams, and even the same families.

"If we get this right, it will revolutionise the way we do research in pregnancy and newborn health."

Which antibiotic?

Its first New Zealand pregnancy trial, PROMOAT, will investigate a question clinicians face every day: which antibiotic gives babies the best chance when a woman's waters break too early – a condition known as preterm prelabour rupture of membranes (PPROM).

Around 30 to 40 percent of preterm births are preceded by PPROM, which increases the risk of infection for both mother and baby. Although antibiotics are known to be a good thing and are routinely prescribed, hospitals use different regimens and there is little evidence about which ones work best, Groom says.

PROMOAT will compare three commonly used antibiotic treatments across Australia and New Zealand to determine which delivers the best outcomes for babies.

A crucial factor about PLATIPUS is it is a so-called “adaptive” platform, Groom says. As evidence accumulates, treatments that are performing less well can be dropped, while new questions can be added without building an entirely new clinical trial.

If one antibiotic turned out to work better than the other two, for example, the PROMOAT researchers could switch to investigating the best dose to give, or the optimum length of treatment. 

"Most of our trials won't be testing brand-new medicines or therapies," says Groom. "We'll be comparing treatments clinicians are already using every day, so we can find out which works best for mothers and babies."

Adaptive platform trials have been around for more than a decade, but came into their own during COVID-19, Groom says. 

"In early March 2020, as news was coming out of China about the impending pandemic, Professor Martin Landray, a doctor and designer of large-scale drug trials, and Sir Jeremy Farrar, director of the Wellcome medical research trust were sitting on a number 18 London bus asking themselves, 'How are we going to work out which are the best treatments for all these COVID patients?' 

“They realised they needed a completely different kind of clinical trial and that's where adaptive platforms really came into their own. 

“We're now bringing that same approach to pregnancy and newborn care for the first time."

One scale for all newborns

Another thing that makes PLATIPUS different is every study uses the same baby and child health and development scale. All newborns, whether born at 23 or at 37 weeks, and regardless of which trial they are part of, can be placed somewhere on this scale soon after birth, Groom says. 

“We then hope to measure their progress, potentially for years.” 

This should allow researchers to compare treatments directly and identify much more quickly which approaches give babies the best chance of healthy development.

“Because multiple studies share the same platform, families can participate in more than one research domain while completing a single programme of follow-up,” Groom says.

“Instead of asking families to enrol in several separate clinical trials, they join one research programme that can answer multiple questions over time.”

True partners

The Health Research Council funding marks the first significant New Zealand investment in PLATIPUS, which until now has been largely supported through Australian funding, Groom says.

"We are excited to have HRC funding to support Aotearoa as a true partner in PLATIPUS and PROMOAT.”

The funding will also help more hospitals across New Zealand take part in clinical research, giving more families the opportunity to contribute to studies that could improve care for future generations.

PLATIPUS has also been developed with a strong focus on equity, Groom says, with Māori partners helping shape its governance and data practices to align with Māori data sovereignty principles.

The University of Auckland and the Carosika Collaborative, a Liggins-based group working to reduce the number of preterm births and improve outcomes for those experiencing preterm birth in New Zealand, are both partners in PLATIPUS. Carosika has the principle of equity for all whānau at its core.

PROMOAT and BabyCCINO (the first neonatal trial on the platform, comparing the different doses and regimens of caffeine given to very preterm infants with breathing problems) are expected to begin recruiting participants across Australia and New Zealand later this year.

Media contact

Nikki Mandow | Research communications
M: 021 174 3142
E: nikki.mandow@auckland.ac.nz