A Phase 4 interventional study of Standard care Cow's milk based formula and Dietary Supplement: PDHM Pasteurised Donor Human Milk in Neonatal Hypoglycemia, Metabolic Complication and Cows Milk Allergy, sponsored by The University of Queensland. Recruiting at 4 sites in Australia. Open to participants aged 0 Hours to 48 Hours. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by The University of Queensland · Phase 4, Interventional, and Prevention
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy.
There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \& 6 weeks and 6 \& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life [including anxiety and depression symptoms and health-related quality of life] along with infant cow's milk allergy symptoms.
Diabetes in pregnancy is becoming increasingly common globally, with more than 40 000 infants born to women with gestational diabetes alone in Australia each year. These infants are at a high risk of hypoglycaemia and often require admission to the neonatal intensive care unit (NICU) and frequent blood tests for glucose monitoring. Many lack access to sufficient maternal milk partly due to delayed lactogenesis, leading to reliance on cow's milk formula, which may increase risks of cow's milk allergy, early breastfeeding cessation, and long-term metabolic complications.
Pasteurized Donor Human milk (PDHM) supplementation represents an alternative to infant formula when sufficient mother's own milk is not available. In Australia, donor milk is already in use for more vulnerable populations (those born very preterm or of a very low birth weight). However, PDHM is not currently available for term infants, despite strong clinician and community demand.
Expanding the availability of PDHM to term infants has the potential to improve health outcomes for a much larger proportion of the population, with potential benefits for mothers and infants including a reduction in admissions to neonatal intensive care units, a reduction in cow's milk allergy in infants, and improved maternal mental health and breastfeeding outcomes.
Our project will assess the provision of PDHM as in-hospital supplementation for term infants who would otherwise be given cow's milk formula. This trial will address a significant gap in neonatal care and provide evidence to determine whether broader PDHM use could improve both mothers' and infants' long-term health outcomes.
147 studies on the registry are indexed under Milk Hypersensitivity; 26 are open to participants now.
This study's planned enrollment of 1,444 is above the median of 68 across 95 interventional studies indexed under Milk Hypersensitivity.
Browse Milk Hypersensitivity studies →The University of Queensland is the lead sponsor of 91 studies on the registry; 24 are open to participants now.
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Each participant must meet all the following criteria to be enrolled in this trial:
Exclusion Criteria:
Mother/infant pairs meeting any of the following criteria will be excluded from the trial:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All infants in this group will get access to Pasteurised donor human milk (PDHM) as supplementary nutrition. PDHM will be made available to the intervention group from the time of randomisation until day 5 of life. Families will be provided with a sufficient supply of frozen PDHM for home use to ensure an exclusively human milk diet up to day 5 of life if their infant is discharged before day 5. Access to PDHM will cease after 120 hours of life, and the infant will be fed according to standard hospital protocols or as per parent's decision.
Dietary Supplement: Dietary Supplement: PDHM Pasteurised Donor Human Milk
All infants in this group will receive the standard care as per local unit policy, including supplemental nutrition (e.g. infant cow's milk formula or IV fluids) as recommended by the treating clinician
Other: Standard care Cow's milk based formula
Standard hospital care would be given as as per local unit policy at the site.
Also known as: Standard Care_Formula milk
PDHM will be given to infants randomised to the intervention group
Also known as: PDHM_Donor milk
Proportion of infants admitted to neonatal unit for management of hypoglycaemia
Proportion of infants in intervention and standard care groups admitted to a neonatal unit for management of hypoglycaemia.
Time frame: From birth to 120 hours of life
Duration of hypoglycaemia (<2.6 mmol/L)
Length of time until 3 consecutive total blood glucose \>2.6 mmol/L (hours) from randomization
Time frame: From birth upto 120 hours of life
Proportion of infants requiring IV access for dextrose
By assessing the proportion of infants cannulated for IV dextrose during hospital admission or re-admission within 30 days of discharge.
Time frame: From birth to 30 days after hospital discharge
Episodes of phlebotomy
By assessing the number of episodes of phlebotomy during initial hospital admission to discharge (infant).
Time frame: From birth up to 120 hours of life
Hospital length of stay (infant)
Duration of hospital stay from birth to hospital discharge, measured in hours.
Time frame: From birth up to initial hospital discharge, up to 90 days of life
Hospital re-admission within 30 days
By assessing the proportion of infants with hospital re-admission within 30 days of discharge
Time frame: From birth to 30 days after discharge
Neonatal unit admission and length of stay (infant)
By assessing the proportion of infants admitted to the neonatal unit. For those admitted: the duration of admission (hours) will also be recorded.
Time frame: From birth to initial hospital discharge, up to 90 days of life
Breast milk feeding
An electronic questionnaire/survey will ask about any breast milk and/or exclusive breast milk feeding on separate occasions, including - * Day of onset of secretory activation * Infant receiving breastmilk (any, exclusive) in the previous 24 hours * at 2 weeks * at 6 weeks * at 6 months of age * Total duration of any breast milk feeding When relevant, would ask the reasons for stopping breastfeeding
Time frame: Breast milk feeding at 120 hours of age (this means received any breast milk in previous 24 hours) and at 2 & 6 weeks and 6 months of age
Use of Formula feeding
Any formula use; exclusive use of formula: * in 24 hours prior to discharge * at 2 weeks * at 6 weeks * at 6 months of age The timing of the first formula use (to estimate the duration of end of exclusive human milk-only feeding) will also be recorded.
Time frame: Infant formula feeding at 120 hours of age (received any infant formula in previous 24 hours), and at 2 & 6 weeks and 6 &12 months of age
Maternal mental health in the post-partum period GAD-7
Assessment of maternal anxiety and depression symptoms using the Generalized Anxiety Disorder 7 questionnaire, where scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Time frame: At 6 weeks and 6 months post delivery
Maternal mental health in the post-partum period using PHQ-9 survey
Assessment of maternal anxiety and depression symptoms using the Patient Health Questionnaire 9, where scores 5, 10, 15, and 20 represent cut-off points for mild, moderate, moderately severe, and severe depression, respectively.
Time frame: At 6 weeks and 6 months post delivery
Maternal & Infant Health-related quality of life using AQoL-4D
The Assessment of Quality of Life Measure AQoL-4D questionnaire will be used to capture mother's and infants quality of life.
Time frame: At 6 weeks and 6 months post delivery
Maternal & Infant Health-related quality of life using TANDI
The Toddler and Infant questionnaire will be used to capture infant health-related quality of life
Time frame: At 6 weeks and 6 months post delivery
Infant growth up to 12 months
Infant weight at hospital discharge, 4, 8 and 12 months of age (self-reported)
Time frame: At 4, 8 and 12 months of age
Maternal metabolic health
Maternal weight (self-reported)
Time frame: At pre-birth, 6 and 12 months post delivery
Maternal metabolic health
By assessing maternal glucose tolerance test
Time frame: At 6-8 weeks after delivery
Infant cow's milk allergy using Questionnaires
Using an electronic survey asking about the symptoms related to cow's milk allergy
Time frame: At 6 and 12 months
Infant cow's milk allergy using SPT
More assessment will done using a skin prick test if required to confirm allergy status
Time frame: At 6 and 12 months
Infant cow's milk allergy using OFC challenge
Infants with a positive skin test will be further invited for an oral food challenge assessment, if required, to confirm allergy status
Time frame: At 6 and 12 months
Infant antibiotic use in the first 12-months of life
By assessing the parent's reports on the use of antibiotics
Time frame: At 6 weeks, 6 and 12 months
Proportion of infants hospitalised with an infection in the first year of life
By assessing the parents' report for - * Antibiotic use in the first 12 months of life * Hospitalisation for infection in the first 12 months of life
Time frame: At 6 weeks, 6 and 12 months of age
Exploratory outcomes: To explore the experience of supplementing using Pasteurised donor milk supplementation
To explore and understand the Stakeholder experience of PDHM (parents in both arms of trial; staff including midwives, lactation consultants, neonatologists, neonatal nurses, obstetricians, managers) using in depth parent interviews and non-participant interviews.
Time frame: At 6 week to 3 months
Plan to share: No — All information collected during this study, including individual participant's personal health information, will be kept confidential and will not be shared with anyone outside the study unless required by law. Participants will not be named in any reports, publications, or presentations that may come from this study.
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