Pasteurised Donor Human Milk Supplementation for Term Babies
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.
Study details:
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' and long-term health outcomes.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- 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
- 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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
PREVENTION
Phase
- PHASE4
Study ID
NCT06993103
Intervention or treatment
DIETARY_SUPPLEMENT: Standard care Cow's milk based formula
DIETARY_SUPPLEMENT: Dietary Supplement: PDHM Pasteurised Donor Human Milk
Conditions
- Neonatal Hypoglycemia
- Metabolic Complication
- Cows Milk Allergy
- Hospital Length of Stay
- Neonatal Intensive Care Unit
- Breastfeeding
- Mental Health Issue
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Research sites nearby
Closest Location:
Royal Brisbane and Womens Hospital (QLD)
Select from list below to view details:
Royal Brisbane and Womens Hospital (QLD)
Brisbane, Queensland, Australia
Greenslope Hospital (QLD)
Brisbane, Queensland, Australia
Frances Perry House (VIC)
Melbourne, Victoria, Australia
Royal Womens Hospital (VIC)
Melbourne, Victoria, Australia
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Who is running the clinical trial?
The University of Queensland
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: PDHM - Pasteurised donor human milk
| Dietary Supplement: Dietary Supplement: PDHM Pasteurised Donor Human Milk |
ACTIVE_COMPARATOR: Standard Care
| Other: Standard care Cow's milk based formula |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From birth to 120 hours of life |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Duration of hypoglycaemia (<2.6 mmol/L) | Length of time until 3 consecutive total blood glucose \>2.6 mmol/L (hours) from randomization | 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. | 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). | 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. | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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 | 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) | At 4, 8 and 12 months of age |
| Maternal metabolic health | Maternal weight (self-reported) | At pre-birth, 6 and 12 months post delivery |
| Maternal metabolic health | By assessing maternal glucose tolerance test | 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 | 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 | 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 | 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 | 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 | At 6 weeks, 6 and 12 months of age |
References
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