Saving more premature babies

Could Point of Care Trials be one solution?

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Feeding during neonatal care. Photo credit : WHEAT trial 

Globally, approximately 1 in 10 babies are born premature with complications of prematurity being the number one cause of death in children under 5 years of age.

Despite the continuing advancement at this crucial stage, there are still many unanswered questions on differences in care given to these critically ill and early babies.

To address the uncertainties in neonatal care, high quality, large clinical trials are needed.

As the mother of 3 premature babies, I understand that the care my babies received was available as a result of previous research. However, considering research on my own sick baby at the time of their birth and in the days that followed was a very emotional process. And for staff, research under intensive care situations is often seen as an add-on rather than a routine aspect of standard care. Performing trials under these conditions can be expensive, burdensome to undertake, hard to recruit and can take many years to complete.

Since 2012, I have had the immense privilege, as a consumer, to be included as an Associate Investigator alongside researchers on a number of Australian and international neonatal trials. Knowing the importance of trials and the challenges to get results quickly into practice, at this year’s Perinatal Society of Australia and New Zealand (PSANZ) Annual Congress, researchers asked that very question, ‘How do we embed research into clinical practice so that research becomes a routine aspect of standard care rather than an add-on?’

Could it possible that there is some reluctance to normalise research because medicine is a fact-based profession and the perceived implication that the search for improvement is equal to knowledge lacking?

I don’t think so …. and imagine the number of babies this could save.

One solution to this could be Point of Care Trials (PoCTs). Like conventional Randomised Controlled Trials (RCTs), Point of Care Trials still involve the randomisation of babies but they utilise data that is already collected in routine practice to answer clinical questions.

So, advancing healthcare with data already collected? It almost begs to ask, why hasn’t this been happening all along?

Worldwide, clinicians as well as parents and families of newborns are overwhelming supportive of this approach. PoCTs offers a simpler and more efficient way of reducing uncertainties and could potentially speed up the process of advancing healthcare.

Already underway in the UK is the WHEAT trial. It is the first ever neonatal multi-site registry or point of care trial with proposals underway for Australia, New Zealand and Canada to join.

WHEAT (WithHolding or continuing Enteral feeds Around blood Transfusion) aims to see if withholding milk feeds around blood transfusions can reduce Necrotising Enterocolitis (NEC), a very serious gastrointestinal inflammatory disease that affects 1 in 20 very preterm babies. About 1 in 3 babies with NEC die or need surgery and many survivors have long-term health problems like poor growth and developmental delay.

It is currently not known if continuing or stopping feeds during blood transfusions is better to reduce NEC and a survey in over 200 neonatal units worldwide confirms that both practices are common, often within the same neonatal care unit.

As an innovative international collaboration that will use routine data already recorded by doctors and nurses in the daily care of thousands of babies around the world, the proposed extension of the UK WHEAT aims to answer this question by enrolling over 10,000 preterm babies of less than 30 weeks gestation from Europe, North and South America, Africa, Asia, Australia and New Zealand.

And as a Point of Care Trial, it also aims to show that it can run alongside other trials and alongside standard care with almost no extra work and with the potential to make a lifesaving difference to so many precious preterm babies.

You can have your say by completing a 5 minute survey on your views about the WHEAT Trial here (no personal details are required)

Dr Chris Gale and Professor Neena Modi discuss the UK WHEAT trial and describe how neonatal point of care trials can simplify neonatal research:

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