PRESENT trial: PasteuRisEd donor human milk SupplEmentatioN for Term babies

What is the PRESENT Study?

About 2 in 3 babies born to mothers with diabetes are given infant formula to manage their blood sugar levels. If their blood sugar falls below a certain level, babies may need extra care in the neonatal unit.

In this study we are exploring whether giving donor breastmilk instead of formula when babies need additional milk may help keep their blood sugar levels stable, and stop them needing admission to a neonatal unit. We also want to find out whether donor milk can help support breastfeeding, improve parent’s mental wellbeing, or reduce the risk of allergy.

What is donor breastmilk?

Breastfeeding mothers donate breastmilk to Australian Red Cross Lifeblood. Australian Red Cross Lifeblood screen all donors and pasteurise the milk to kill any bacteria or viruses that could be present, before freezing it and providing it to hospitals around Australia. Donor breastmilk is currently used on neonatal units for babies who are born very early, but isn’t commonly available for babies born at term.

What is involved?

After birth, mothers will be supported and encouraged to breastfeed their babies. Babies born to mothers with diabetes will have their blood sugar levels checked as part of their usual care. If a baby has a low blood sugar they will be randomly assigned to received either donor milk or formula (the usual care) for any additional milk they may need in the first five days of life. Participants will be asked to complete short surveys at 2 weeks, 6 weeks, 6 months and 12 months. If a baby shows signs of milk allergy at 6 or 12 months, they may be invited for allergy testing.

Where is the study taking place?

The PRESENT study is taking place at the Royal Women’s Hospital (VIC), Frances Perry House (Ramsay Health VIC), Royal Brisbane and Women’s Hospital (QLD) and Greenslopes Private Hospital (Ramsay Health QLD).

It is led by researchers at the University of Queensland and Murdoch Children’s Research Institute, in collaboration with Australian Red Cross Lifeblood.

Who is eligible to take part?

Mothers who are pregnant and managing diabetes, and plan to give birth at one of hospitals mentioned above where the study is taking place, are invited to take part in this study.