Research in the NICU

As the parent of a NICU baby, it can be a terrifying experience to watch the process and amount of care that is required for the best outcome for your baby.

You may also, though, be feeling some relief and gratitude for the medical technology and highly skilled staff working for your baby’s survival and ongoing development.

For this to exist, there is an underlying understanding that the care our families receive today is available as a result of others before them taking part in research. And that those who participate in research contribute to improvements in standards of care and long-term quality of life.

Research happens in NICUs across Australia and around the world and you and your baby may be invited to participate in one or more trials.

Some of the trials currently recruiting within Australian NICUs can be found at:

• https://impact.psanz.com.au/clinical-trials/clinical-trials-2/
• https://ctc.usyd.edu.au/our-work/research-divisions/neonatal-and-perinatal/

Evidence:

Trial unpredictability yields predictable therapy gains -

https://pubmed.ncbi.nlm.nih.gov/23969443/

Djulbegovic B, Kumar A, Glasziou P, Miladinovic B, Chalmers I. Nature 2013:500:395

“In publicly sponsored Randomised Controlled Trials (RCTs), the likelihood that new treatments would work better than existing ones ranges from 57% to 63% for patient survival and from 55% to 66% for all primary outcomes (such as survival without recurrence of disease, response to treatment, symptom frequency and measures of disability). The only available comparable rates for industry sponsored RCTs show that, overall, new treatments are superior to existing treatments for measures of morbidity (nausea, for example) in 75% of trials, but similar (53%) for survival. Over time, the pattern in all trials has converged at around 50% (probably because earlier studies used inferior comparators) and applies across various clinical fields and types of treatment.”

Education:

Clinical trials are medical research studies that aim to find a better way to manage or treat a particular disease or condition. The purpose of a clinical trial within a NICU is to evaluate new approaches and help advance the care your baby is already receiving.

Clinical trials are considered to be part of best practice medicine and are one of many options for treatment of a disease or condition encountered by your baby.

What are clinical trials?

What is randomisation?

Click here for a downloadable guide for patients from the Australian Clinical Trials Alliance.

Empowerment:

The NICU can be a very daunting and overwhelming place. Your baby’s entry into the world may have been traumatic and with so much already going on, it may feel like a burden to be approached for your baby to participate in a research trial.

You may also have some fears about saying yes to your baby being included in research.

This is very normal.

It is important to know that every trial that happens within Australian NICUs have gone through very strict protocols and guidelines, have had input by NICU parents like you and have undergone independent ethics approvals.

Evidence exists that shows that by entering a Phase III Randomised Controlled Trial, babies have a better chance of receiving superior treatment than by having usual care.

Some things you can do includes:

• Asking your doctor and nurses if there are any trials you and your baby can join?
• Have an in-depth discussion with the researcher coordinator on staff about any trials suitable for your baby.

It is important to that you are not required to say yes to any trial that you are approached for and once saying yes, you are able to leave a clinical trial at any time and are not obliged to remain in a trial if you no longer wish to participate.

Benefits of being in a clinical trial:

• Participating in a clinical trial could result in benefits for your baby
• Clinical trials enable babies to access the newest, most up-to-date research treatments
• Participating in a clinical trial may also allow parents to gain advice and treatment from leading medical experts in cutting edge medical facilities and provide them with greater understanding of their baby’s condition or illness
• Participating in a clinical trial also allows you to play an active role in their healthcare and their treatment
• Clinical trials may be important for babies with rare or difficult to treat conditions for which there may be limited evidence about how the condition is best treated or managed
• Babies participating in clinical trials may be monitored more closely and comprehensively compared with those receiving standard treatment
• The knowledge that your baby has been a part of health advancement which may benefit future babies born in similar situations