Pasteurised Donor Human Milk Supplementation for Term Babies
NCT ID: NCT06993103
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
1444 participants
INTERVENTIONAL
2025-06-02
2028-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
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.
Study Groups
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PDHM - Pasteurised donor human milk
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: PDHM Pasteurised Donor Human Milk
PDHM will be given to infants randomised to the intervention group
Standard Care
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
Standard care Cow's milk based formula
Standard hospital care would be given as as per local unit policy at the site.
Interventions
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Standard care Cow's milk based formula
Standard hospital care would be given as as per local unit policy at the site.
Dietary Supplement: PDHM Pasteurised Donor Human Milk
PDHM will be given to infants randomised to the intervention group
Other Intervention Names
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Eligibility Criteria
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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
0 Hours
48 Hours
ALL
No
Sponsors
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Murdoch Childrens Research Institute
OTHER
La Trobe University
OTHER
University of Melbourne
OTHER
South Australian Health and Medical Research Institute
OTHER
Australian Red Cross Lifeblood
UNKNOWN
Ramsay Hospital Research Foundation
UNKNOWN
Monash University
OTHER
The Royal Women Hospital
UNKNOWN
Greenslopes Private Hospital
UNKNOWN
Frances Perry House
UNKNOWN
The University of Queensland
OTHER
Responsible Party
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Principal Investigators
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Jennifer Koplin, PhD
Role: PRINCIPAL_INVESTIGATOR
Child Health Research Centre, University Of Queensland
Locations
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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
Countries
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Central Contacts
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References
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Griffith RJ, Harding JE, McKinlay CJD, Wouldes TA, Harris DL, Alsweiler JM; CHYLD Study Team. Maternal glycemic control in diabetic pregnancies and neurodevelopmental outcomes in preschool aged children. A prospective cohort study. Early Hum Dev. 2019 Mar;130:101-108. doi: 10.1016/j.earlhumdev.2019.01.010. Epub 2019 Feb 1. No abstract available.
Shah R, Harding J, Brown J, McKinlay C. Neonatal Glycaemia and Neurodevelopmental Outcomes: A Systematic Review and Meta-Analysis. Neonatology. 2019;115(2):116-126. doi: 10.1159/000492859. Epub 2018 Nov 8.
Forster DA, Moorhead AM, Jacobs SE, Davis PG, Walker SP, McEgan KM, Opie GF, Donath SM, Gold L, McNamara C, Aylward A, East C, Ford R, Amir LH. Advising women with diabetes in pregnancy to express breastmilk in late pregnancy (Diabetes and Antenatal Milk Expressing [DAME]): a multicentre, unblinded, randomised controlled trial. Lancet. 2017 Jun 3;389(10085):2204-2213. doi: 10.1016/S0140-6736(17)31373-9.
Gertz B, DeFranco E. Predictors of breastfeeding non-initiation in the NICU. Matern Child Nutr. 2019 Jul;15(3):e12797. doi: 10.1111/mcn.12797. Epub 2019 Apr 2.
De Bortoli J, Amir LH. Is onset of lactation delayed in women with diabetes in pregnancy? A systematic review. Diabet Med. 2016 Jan;33(1):17-24. doi: 10.1111/dme.12846. Epub 2015 Aug 18.
Clifford V, Klein LD, Brown R, Sulfaro C, Hoad V, Gosbell IB, Pink J. Donor and recipient safety in human milk banking. J Paediatr Child Health. 2022 Sep;58(9):1629-1634. doi: 10.1111/jpc.16066. Epub 2022 Jul 2.
Clifford V, Klein LD, Sulfaro C, Karalis T, Hoad V, Gosbell I, Pink J. What are Optimal Bacteriological Screening Test Cut-Offs for Pasteurized Donor Human Milk Intended for Feeding Preterm Infants? J Hum Lact. 2021 Feb;37(1):43-51. doi: 10.1177/0890334420981013. Epub 2020 Dec 22.
Urashima M, Mezawa H, Okuyama M, Urashima T, Hirano D, Gocho N, Tachimoto H. Primary Prevention of Cow's Milk Sensitization and Food Allergy by Avoiding Supplementation With Cow's Milk Formula at Birth: A Randomized Clinical Trial. JAMA Pediatr. 2019 Dec 1;173(12):1137-1145. doi: 10.1001/jamapediatrics.2019.3544.
Halken S, Muraro A, de Silva D, Khaleva E, Angier E, Arasi S, Arshad H, Bahnson HT, Beyer K, Boyle R, du Toit G, Ebisawa M, Eigenmann P, Grimshaw K, Hoest A, Jones C, Lack G, Nadeau K, O'Mahony L, Szajewska H, Venter C, Verhasselt V, Wong GWK, Roberts G; European Academy of Allergy and Clinical Immunology Food Allergy and Anaphylaxis Guidelines Group. EAACI guideline: Preventing the development of food allergy in infants and young children (2020 update). Pediatr Allergy Immunol. 2021 Jul;32(5):843-858. doi: 10.1111/pai.13496. Epub 2021 Mar 29.
Titmuss A, Longmore DK, Barzi F, Barr ELM, Webster V, Wood A, Simmonds A, Brown ADH, Connors C, Boyle JA, Oats J, McIntyre HD, Shaw JE, Craig ME, Maple-Brown LJ; PANDORA Study Research Team. Association between hyperglycaemia in pregnancy and growth of offspring in early childhood: The PANDORA study. Pediatr Obes. 2022 Oct;17(10):e12932. doi: 10.1111/ijpo.12932. Epub 2022 May 29.
Other Identifiers
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2024607
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2024-607
Identifier Type: -
Identifier Source: org_study_id
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