The PRESENT trial: An RCT of Pasteurised Donor Human Milk supplementation for term babies born to Women with Diabetes. — ASN Events
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  2. Session 3A - Breakout Session - Complications of diabetes
  3. The PRESENT trial: An RCT of Pasteurised Donor Human Milk supplementation for term babies born to Women with Diabetes.

The PRESENT trial: An RCT of Pasteurised Donor Human Milk supplementation for term babies born to Women with Diabetes. (#16)

Anna Tottman 1 2 , V Clifford 2 3 , J Koplin 2 4
  1. Neonatal Services, Royal Women's Hospital, Parkville, VIC, Australia
  2. Murdoch Children's Research Institute, Parkville, VIC, Australia
  3. Australian Red Cross Lifeblood, Melbourne, VIC, Australia
  4. Child Health Research Centre, University of Queensland, Brisbane, QLD, Australia

Background:  Infants born to women with diabetes are at risk of neonatal hypoglycaemia, and women with diabetes in pregnancy may have delayed lactogenesis.  Thus, infants may not have access to sufficient maternal milk to maintain normoglycaemia in the first few days of life. These infants frequently require supplementary artificial formula feeds and/or maternal separation for intravenous glucose delivery.

The PRESENT trial is a multi-centre, randomised controlled trial of access to pasteurised donor human milk (PDHM) vs standard care in term infants born to women with diabetes, and with hypoglycaemia. The primary outcome is admission to a neonatal unit for hypoglycaemia, with secondary outcomes including short-term (hypoglycaemia incidence and duration, blood sampling episodes, length of stay) and longer-term outcomes to 12 months of age (breastfeeding duration and exclusivity, maternal mental health, cow’s milk protein allergy and interest holder experience).

Method and analysis:  Eligibility criteria include maternal diabetes in pregnancy (any type), maternal plan to breastfeed after birth, and term gestational age.   Following antenatal consent, infants will be 1:1 randomised to open label PDHM access or standard care if they have a true blood glucose 1.5 – 2.5 mmol/L in the 48 hours after birth. At the Royal Women’s Hospital, randomisation will take place via the Electronic Medical Record.  Infants randomised to PDHM access may receive PDHM as a supplement to breastfeeding until 120 hours of life, including at home if the infant is discharged prior. 

The primary outcome of admission to a neonatal unit for hypoglycaemia will be analysed based on intention to treat, with the proportion of infants reaching the primary outcome calculated as event numbers and percentages by group allocation, and compared using RR with 95% CI (with standard care as the reference group).

Secondary outcomes will be derived from the hospital electronic medical record, and from electronic questionnaires sent to parents.  Site visits at 6 and 12 months of age will be offered for allergy assessment for infants where symptoms of potential cow’s milk protein allergy are reported. 

Ethics:  Approved by Royal Melbourne Hospital human research ethics committee (HREC/107372/MH-2024; 19/12/2024). 

Clinical Trial registration: NCT06993103