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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06993103




Registration number
NCT06993103
Ethics application status
Date submitted
25/03/2025
Date registered
28/05/2025
Date last updated
28/05/2025

Titles & IDs
Public title
Pasteurised Donor Human Milk Supplementation for Term Babies
Scientific title
A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.
Secondary ID [1] 0 0
2024607
Secondary ID [2] 0 0
2024-607
Universal Trial Number (UTN)
Trial acronym
PRESENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neonatal Hypoglycemia 0 0
Metabolic Complication 0 0
Cows Milk Allergy 0 0
Hospital Length of Stay 0 0
Neonatal Intensive Care Unit 0 0
Breastfeeding 0 0
Mental Health Issue 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Standard care Cow's milk based formula
Treatment: Other - Dietary Supplement: PDHM Pasteurised Donor Human Milk

Experimental: 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.

Active comparator: 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


Treatment: Other: Standard care Cow's milk based formula
Standard hospital care would be given as as per local unit policy at the site.

Treatment: Other: Dietary Supplement: PDHM Pasteurised Donor Human Milk
PDHM will be given to infants randomised to the intervention group
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of infants admitted to neonatal unit for management of hypoglycaemia
Timepoint [1] 0 0
From birth to 120 hours of life
Secondary outcome [1] 0 0
Duration of hypoglycaemia (<2.6 mmol/L)
Timepoint [1] 0 0
From birth upto 120 hours of life
Secondary outcome [2] 0 0
Proportion of infants requiring IV access for dextrose
Timepoint [2] 0 0
From birth to 30 days after hospital discharge
Secondary outcome [3] 0 0
Episodes of phlebotomy
Timepoint [3] 0 0
From birth up to 120 hours of life
Secondary outcome [4] 0 0
Hospital length of stay (infant)
Timepoint [4] 0 0
From birth up to initial hospital discharge, up to 90 days of life
Secondary outcome [5] 0 0
Hospital re-admission within 30 days
Timepoint [5] 0 0
From birth to 30 days after discharge
Secondary outcome [6] 0 0
Neonatal unit admission and length of stay (infant)
Timepoint [6] 0 0
From birth to initial hospital discharge, up to 90 days of life
Secondary outcome [7] 0 0
Breast milk feeding
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Use of Formula feeding
Timepoint [8] 0 0
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
Secondary outcome [9] 0 0
Maternal mental health in the post-partum period GAD-7
Timepoint [9] 0 0
At 6 weeks and 6 months post delivery
Secondary outcome [10] 0 0
Maternal mental health in the post-partum period using PHQ-9 survey
Timepoint [10] 0 0
At 6 weeks and 6 months post delivery
Secondary outcome [11] 0 0
Maternal & Infant Health-related quality of life using AQoL-4D
Timepoint [11] 0 0
At 6 weeks and 6 months post delivery
Secondary outcome [12] 0 0
Maternal & Infant Health-related quality of life using TANDI
Timepoint [12] 0 0
At 6 weeks and 6 months post delivery
Secondary outcome [13] 0 0
Infant growth up to 12 months
Timepoint [13] 0 0
At 4, 8 and 12 months of age
Secondary outcome [14] 0 0
Maternal metabolic health
Timepoint [14] 0 0
At pre-birth, 6 and 12 months post delivery
Secondary outcome [15] 0 0
Maternal metabolic health
Timepoint [15] 0 0
At 6-8 weeks after delivery
Secondary outcome [16] 0 0
Infant cow's milk allergy using Questionnaires
Timepoint [16] 0 0
At 6 and 12 months
Secondary outcome [17] 0 0
Infant cow's milk allergy using SPT
Timepoint [17] 0 0
At 6 and 12 months
Secondary outcome [18] 0 0
Infant cow's milk allergy using OFC challenge
Timepoint [18] 0 0
At 6 and 12 months
Secondary outcome [19] 0 0
Infant antibiotic use in the first 12-months of life
Timepoint [19] 0 0
At 6 weeks, 6 and 12 months
Secondary outcome [20] 0 0
Proportion of infants hospitalised with an infection in the first year of life
Timepoint [20] 0 0
At 6 weeks, 6 and 12 months of age

Eligibility
Key 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.
Minimum age
0 Hours
Maximum age
48 Hours
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
1444
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Womens Hospital (QLD) - Brisbane
Recruitment hospital [2] 0 0
Greenslope Hospital (QLD) - Brisbane
Recruitment hospital [3] 0 0
Frances Perry House (VIC) - Melbourne
Recruitment hospital [4] 0 0
Royal Womens Hospital (VIC) - Melbourne
Recruitment postcode(s) [1] 0 0
4010 - Brisbane
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Murdoch Childrens Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
La Trobe University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Melbourne
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
South Australian Health and Medical Research Institute
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Australian Red Cross Lifeblood
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Ramsay Hospital Research Foundation
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Monash University
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
The Royal Women Hospital
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
Greenslopes Private Hospital
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Frances Perry House
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Koplin, PhD
Address 0 0
Child Health Research Centre, University Of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jennifer Koplin, PhD
Address 0 0
Country 0 0
Phone 0 0
061+0400032577
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06993103