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.
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
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.
Parallel
Standard care Cow's milk based formula
Other interventionStandard hospital care would be given as as per local unit policy at the site.
Dietary Supplement: PDHM Pasteurised Donor Human Milk
Dietary supplementPDHM will be given to infants randomised to the intervention group
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.
Duration of hypoglycaemia (<2.6 mmol/L)
Length of time until 3 consecutive total blood glucose \>2.6 mmol/L (hours) from randomization
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.
Episodes of phlebotomy
By assessing the number of episodes of phlebotomy during initial hospital admission to discharge (infant).
Hospital length of stay (infant)
Duration of hospital stay from birth to hospital discharge, measured in hours.
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.
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The University of Queensland
Lead sponsor
Murdoch Childrens Research Institute
Collaborator
La Trobe University
Collaborator
University of Melbourne
Collaborator
South Australian Health and Medical Research Institute
Collaborator
Australian Red Cross Lifeblood
Collaborator
Monash University
Collaborator
The Royal Women Hospital
Collaborator
Frances Perry House (Ramsay Health)
Collaborator
Ramsay Hospital Research Foundation
Collaborator
