Not yet recruitingNAINTERVENTIONAL

Preemie Milk Analyser Validation Study

This study is testing a new device, called the Preemie Ecosystem, that measures the fat, protein, and sugar in a mother's breast milk. This is important because premature babies need very specific nutrition for growth, and each mother's milk is unique. Currently, a standard supplement is added to breast milk, but this new device could help doctors add just the right amount for each baby. The study will first check how accurate the device is, then see if using it to personalise milk feeding helps premature babies grow better compared to the standard approach. The goal is to get official certification for the device to be used in hospitals.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

180

Start

01 Jul 2024

Estimated completion

01 Jul 2026

Pre-Term Breast Milk Expression Nutrition Disorder, Infant

What is this study about?

Premature babies, born early, have special nutritional needs because they need to grow rapidly. Mothers' breast milk is wonderful, but sometimes it needs a little extra boost of nutrients like fat, protein, and sugar to help these babies thrive. Currently, hospitals add a standard amount of supplement to breast milk for premature babies. However, we know that each mother's milk is different and can change from day to day, meaning a 'one-size-fits-all' approach might not be perfect.

This study is looking at a new device called the 'Preemie Ecosystem', which includes a device and special software. This system aims to quickly and accurately measure the nutrient content of a mother's breast milk. This could allow doctors to precisely tailor the amount of supplement needed for each premature baby, giving them exactly what they need for optimal growth and development.

The study has two main parts. First, it will carefully check how accurate the Preemie device is at measuring the nutrients in breast milk. This will involve comparing the device's measurements to highly accurate laboratory tests. Once they're confident in the device's accuracy, the second part of the study will gently introduce it into care for a small group of premature babies. The researchers will then compare the growth of these babies, who receive personalised milk, with babies who receive the standard, non-individualised milk fortification. The results will help decide if this new technology can be certified for wider use in hospitals.

Key takeaways

Tests a new device to measure nutrients in breast milk for premature babies.
Aims to provide personalised breast milk fortification, not a standard amount.
Could help premature babies receive optimal nutrition for growth.
Compares tailored feeding to the current standard approach.
Results will help decide if the device can be used in hospitals more widely.

Who may be eligible?

For the first part of the study, we are looking for mothers who are either currently expressing breast milk for their baby in the neonatal unit or who donate breast milk to the milk bank. You'd need to have enough milk available so that sharing a small amount for the study wouldn't affect your baby's feeding or your overall donation to the milk bank.

For the second part of the study, we are looking for premature babies who weigh between 1kg and 1.8kg (about 2lb 3oz to 4lb). They should already be receiving fortified breast milk and tolerating it well for at least two days, and no longer needing nutrition through a drip into their veins.

Babies would not be able to join the second part of the study if their mother is struggling to provide enough breast milk, if they have certain serious underlying health conditions like some genetic disorders, or a history of major gut surgery. Babies who are fed only formula, or who have specific serious brain bleeds, would also not be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a mother providing breast milk for your baby in the neonatal unit?
Do you donate breast milk to a milk bank?
Is your baby a premature infant weighing between 1kg and 1.8kg?
Is your baby currently tolerating fortified breast milk feeds well?
Is your baby no longer receiving nutrition through a drip?

Answer every question to see your result.

What does participation involve?

If you take part in the first phase, you will be asked to provide a small amount of your breast milk (about 120ml, which is just under half a cup). This milk will be divided; some will be tested by the Preemie device over a few days, and some will be sent to a specialist lab for very detailed analysis. There are no direct assessments or follow-up for you or your baby in this phase, beyond providing the milk.

If your baby takes part in the second phase, their care will largely continue as normal, but the Preemie device would be used to help decide how much breast milk fortifier they receive. Their growth and nutrient intake will be carefully monitored. The study doesn't involve any extra visits or changes to how your baby is cared for, beyond the tailored milk fortification. The total duration of your baby's participation would depend on their length of stay and requirements for fortified milk.

Potential risks and benefits

There are no direct medical benefits for mothers taking part in the first part of the study, but your contribution will help improve care for premature babies in the future. For babies in the second phase, there's a potential benefit that receiving breast milk more precisely matched to their needs could lead to better growth; however, this is what the study aims to find out. We do not anticipate any risks to mothers providing milk, or to babies taking part, as the study involves monitoring and adjusting an existing treatment, breast milk fortification. Remember, taking part in any study is entirely voluntary, and you are free to withdraw yourself or your baby at any time without giving a reason, and this would not affect your or your baby's medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom

Common questions

What is 'breast milk fortification'?

It's when extra nutrients are added to breast milk to make it richer, which is often needed for babies born early to help them grow well.

What is the Preemie device?

It's a new system that aims to quickly measure the fat, protein, and sugar content in a mother's breast milk.

Why is this study important?

It could help ensure premature babies get precisely the right amount of nutrients from their mother's milk, tailored to their individual needs, which may lead to better growth.

Will my baby receive different care if they join?

In the second phase, your baby's breast milk fortification might be adjusted based on the Preemie device's readings, rather than a standard amount, but their overall care would remain the same.

Can I leave the study at any time?

Yes, taking part is completely voluntary. You can withdraw yourself or your baby from the study at any point without it affecting your medical care.

How to find out more

Andrew Guy

andrew.guy@uhs.nhs.uk +442381205146 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.