Pasteurised Donor Human Milk Supplementation for Term Babies

NCT06993103 | Recruiting Phase 4 DMC

• 2 other identifiers: 2024-6072024607
• Study Type: interventional
• Target: 1,444
• Locations: 1 country
• Sites: 4

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.

Conditions

Neonatal Hypoglycemia; Metabolic Complication; Cows Milk Allergy; Hospital Length of Stay; Neonatal Intensive Care Unit; Breastfeeding; Mental Health Issue

Keywords

Pasteurised donor human milk; Donor breastmilk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Duration of hypoglycaemia (<2.6 mmol/L)

  From birth upto 120 hours of life

• Proportion of infants requiring IV access for dextrose

  From birth to 30 days after hospital discharge

• Episodes of phlebotomy

  From birth up to 120 hours of life

• Hospital length of stay (infant)

  From birth up to initial hospital discharge, up to 90 days of life

• Hospital re-admission within 30 days

  From birth to 30 days after discharge

Other Outcomes (1)

• Exploratory outcomes: To explore the experience of supplementing using Pasteurised donor milk supplementation

  At 6 week to 3 months

Study Arms (2)

PDHM - Pasteurised donor human milk

EXPERIMENTAL

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

Standard Care

ACTIVE COMPARATOR

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

Interventions

Standard care Cow's milk based formula OTHER

Standard hospital care would be given as as per local unit policy at the site.

Also known as: Standard Care_Formula milk

Standard Care

Dietary Supplement: PDHM Pasteurised Donor Human Milk DIETARY_SUPPLEMENT

PDHM will be given to infants randomised to the intervention group

Also known as: PDHM_Donor milk

PDHM - Pasteurised donor human milk

Eligibility Criteria

• Age: 0 Hours - 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Queensland: lead
• 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

Study Sites (4)

Royal Brisbane and Womens Hospital (QLD)

Brisbane, Queensland, 4010, Australia

NOT YET RECRUITING

Greenslope Hospital (QLD)

Brisbane, Queensland, 4101, Australia

NOT YET RECRUITING

Frances Perry House (VIC)

Melbourne, Victoria, Australia

NOT YET RECRUITING

Royal Womens Hospital (VIC)

Melbourne, Victoria, Australia

RECRUITING

Related Publications (10)

• 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.

  PMID: 30716594 BACKGROUND

• 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.

  PMID: 30408811 BACKGROUND

• 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.

  PMID: 28589894 BACKGROUND

• 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.

  PMID: 30767426 BACKGROUND

• 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.

  PMID: 26113051 BACKGROUND

• 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.

  PMID: 35779010 BACKGROUND

• 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.

  PMID: 33351688 BACKGROUND

• 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.

  PMID: 31633778 BACKGROUND

• 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.

  PMID: 33710678 BACKGROUND

• 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.

  PMID: 35644889 BACKGROUND

MeSH Terms

Conditions

Milk Hypersensitivity; Breast Feeding

Condition Hierarchy (Ancestors)

Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Feeding Behavior; Behavior

Study Officials

• Jennifer Koplin, PhD

  Child Health Research Centre, University Of Queensland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Koplin, PhD

CONTACT

061+0400032577; j.koplin@uq.edu.au

Vanessa Clifford, PhD

CONTACT

061+0437 527 044; VClifford@redcrossblood.org.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled intervention trial - control and intervention arm

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: May 28, 2025
• Study Start: December 4, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)