Pasteurised donor human milk for term babies born to mothers with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

PRESENT is a multi-center, randomized controlled trial comparing in-hospital pasteurised donor human milk (PDHM) supplementation versus local standard care (which may include cow's milk formula) for term infants born to women with type 1, type 2, or gestational diabetes. Eligible infants (≥37 weeks, >2.5 kg) whose clinician decides supplemental nutrition is needed within 48 hours of birth are randomized to receive PDHM until day 5 or to continue usual care per local policy. The primary outcome is the proportion of infants admitted to a neonatal unit for management of hypoglycaemia; secondary outcomes include breastfeeding rates, maternal mental health, and infant cow's milk allergy. Parents complete electronic questionnaires at 2 and 6 weeks and 6 and 12 months after birth to capture feeding and health outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Each participant must meet all the following criteria to be enrolled in this trial:

* Mother is \>18 years at the time of consent
* Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)
* Mother intends to breastfeed for at least 6 weeks at the time of consent.
* Infant is born at ≥ 37 weeks and weighs \> 2.5kg
* Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.
* Parent/s provide/s a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion Criteria:

Mother/infant pairs meeting any of the following criteria will be excluded from the trial:

* Multiple pregnancy
* Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy
* Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and/or requiring immediate care in a neonatal unit (e.g., congenital heart disease).
* Infant has received infant formula prior to randomisation.
* Infant admitted to neonatal intensive care prior to randomisation.
* More than 48 hours old at the time of recruitment

Where it's running

• Frances Perry House (VIC)
  Melbourne, Victoria, Australia Recruiting
• Royal Womens Hospital (VIC)
  Melbourne, Victoria, Australia Recruiting
• Royal Brisbane and Womens Hospital (QLD)
  Brisbane, Queensland, Australia Not yet recruiting
• Greenslope Hospital (QLD)
  Brisbane, Queensland, Australia Not yet recruiting

Study contacts

• Principal investigator: Jennifer Koplin, PhD — Child Health Research Centre, University Of Queensland
• Study coordinator: Jennifer Koplin, PhD
• Email: j.koplin@uq.edu.au
• Phone: 061+0400032577

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Earlier use of an electric breast pump to maximize milk in preterm babies

  This study tests whether starting a double electric breast pump earlier (at birth) helps mothers of very preterm infants produce more milk by day 14.

  Recruiting National Maternity Hospital, Ireland · Dublin, Co. Dublin and 2 other locations · NCT07908238

• Methyl-Donor Rich Diet in the Postpartum Period

  Researchers will test whether a methyl-donor‑rich diet in the first weeks after birth helps reduce maternal depression and supports breastfeeding and infant growth.

  Recruiting Istanbul University - Cerrahpasa · Bursa, Orhaneli̇ · NCT07887178

• Alcohol, Breast Milk, and Metabolism in Lactating Women

  This study tests whether breast tissue locally metabolizes alcohol by comparing alcohol-related markers in blood and breast milk from lactating women after low-level alcohol exposure.

  Recruiting University of Illinois at Urbana-Champaign · Urbana, Illinois · NCT07779967

• Relaxation audio during breastfeeding to help newborn growth and mom’s well-being

  Researchers will test if listening to a relaxation audio during breastfeeding helps LBW babies grow and reduces maternal stress in a Ugandan setting.

  Recruiting University of California, San Francisco · Kampala · NCT07774793

• Postoperative Care Pathways: PACU vs HCU in Elective Surgeries

  This study looks at whether recovering in the PACU or the HCU after elective surgery affects how long patients stay in the hospital and how often they need a higher level of care afterward.

  Recruiting Universitas Indonesia · Jakarta Pusat, Jakarta Special Capital Region · NCT07740772

• Breastfeeding education with web portal and app-supported counseling

  This trial tests whether added breastfeeding education plus digital support helps first-time mothers start and continue breastfeeding when they are near delivery.

  Recruiting Aydin Adnan Menderes University · Bursa · NCT07721311

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.