Breastfeeding, Cows Milk Allergy, Hospital Length of Stay, Mental Health Issue, Metabolic Complication, Neonatal Hypoglycemia, Neonatal Intensive Care Unit
Conditions
Keywords
Pasteurised donor human milk, Donor breastmilk
Brief summary
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.
Detailed description
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.
Interventions
OTHERStandard care Cow's milk based formula
Standard hospital care would be given as as per local unit policy at the site.
DIETARY_SUPPLEMENTDietary Supplement: PDHM Pasteurised Donor Human Milk
PDHM will be given to infants randomised to the intervention group
Sponsors
The University of Queensland
Murdoch Childrens Research Institute
La Trobe University
University of Melbourne
South Australian Health and Medical Research Institute
Australian Red Cross Lifeblood
Monash University
The Royal Women Hospital
Frances Perry House (Ramsay Health)
Ramsay Hospital Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This study has 2 treatment arms. In the intervention arm, pasteurised donor human milk (PDHM) is provided to infants needing nutritional supplementation for the first 5 days of life, compared to standard hospital care. Participants will not be blinded to study group allocation, because a key research question concerns the consumer experience of accessing PDHM, including how maternal behaviors differ when receiving PDHM. The idea is that having human milk is a "bridge" to exclusive breast milk feeding, rather than a path to continued formula feeding and shorter breastfeeding duration. Many outcomes, such as maternal mental health, breastfeeding impact of access to PDHM) cannot be assessed in a blinded study. The primary outcome is unlikely to be impacted by lack of clinician blinding. Outcome assessments (analysis of questionnaire responses, skin prick testing for cow's milk allergy) and statistical analyses will be done by assessors blinded to study group allocation.
Intervention model description
Randomized controlled intervention trial - control and intervention arm
Eligibility
Sex/Gender
ALL
Age
0 Years to 48 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of infants admitted to neonatal unit for management of hypoglycaemia | From birth to 120 hours of life | Proportion of infants in intervention and standard care groups admitted to a neonatal unit for management of hypoglycaemia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant cow's milk allergy using Questionnaires | At 6 and 12 months | Using an electronic survey asking about the symptoms related to cow's milk allergy |
| Infant cow's milk allergy using SPT | At 6 and 12 months | More assessment will done using a skin prick test if required to confirm allergy status |
| Infant cow's milk allergy using OFC challenge | At 6 and 12 months | Infants with a positive skin test will be further invited for an oral food challenge assessment, if required, to confirm allergy status |
| Infant antibiotic use in the first 12-months of life | At 6 weeks, 6 and 12 months | By assessing the parent's reports on the use of antibiotics |
| Proportion of infants hospitalised with an infection in the first year of life | At 6 weeks, 6 and 12 months of age | 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 |
| Duration of hypoglycaemia (<2.6 mmol/L) | From birth upto 120 hours of life | Length of time until 3 consecutive total blood glucose \>2.6 mmol/L (hours) from randomization |
| Proportion of infants requiring IV access for dextrose | From birth to 30 days after hospital discharge | By assessing the proportion of infants cannulated for IV dextrose during hospital admission or re-admission within 30 days of discharge. |
| Episodes of phlebotomy | From birth up to 120 hours of life | By assessing the number of episodes of phlebotomy during initial hospital admission to discharge (infant). |
| Hospital length of stay (infant) | From birth up to initial hospital discharge, up to 90 days of life | Duration of hospital stay from birth to hospital discharge, measured in hours. |
| Hospital re-admission within 30 days | From birth to 30 days after discharge | By assessing the proportion of infants with hospital re-admission within 30 days of discharge |
| Neonatal unit admission and length of stay (infant) | From birth to initial hospital discharge, up to 90 days of life | By assessing the proportion of infants admitted to the neonatal unit. For those admitted: the duration of admission (hours) will also be recorded. |
| Breast milk feeding | 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 | 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 |
| Use of Formula feeding | 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 | 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. |
| Maternal mental health in the post-partum period GAD-7 | At 6 weeks and 6 months post delivery | 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. |
| Maternal mental health in the post-partum period using PHQ-9 survey | At 6 weeks and 6 months post delivery | 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. |
| Maternal & Infant Health-related quality of life using AQoL-4D | At 6 weeks and 6 months post delivery | The Assessment of Quality of Life Measure AQoL-4D questionnaire will be used to capture mother's and infants quality of life. |
| Maternal & Infant Health-related quality of life using TANDI | At 6 weeks and 6 months post delivery | The Toddler and Infant questionnaire will be used to capture infant health-related quality of life |
| Maternal metabolic health | At pre-birth, 6 and 12 months post delivery | Maternal weight (self-reported) |
| Infant growth up to 12 months | At 4, 8 and 12 months of age | Infant weight at hospital discharge, 4, 8 and 12 months of age (self-reported) |
Countries
Australia
Contacts
CONTACTJennifer Koplin, PhD
CONTACTVanessa Clifford, PhD
PRINCIPAL_INVESTIGATORJennifer Koplin, PhD
Child Health Research Centre, University Of Queensland
Outcome results
None listed