Neonatal HypoglycemiaPhase 4PRESENTNCT06993103
Pasteurised Donor Human Milk Supplementation for Term Babies
A Phase 4 study testing Dietary Supplement: PDHM Pasteurised Donor Human Milk in people with Neonatal Hypoglycemia and Metabolic Complication, run by The University of Queensland at 4 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 48 hours
- Conditions the study is for
- Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy
- What is being tested?
- Dietary Supplement: PDHM Pasteurised Donor Human Milk
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,444 participants
- Where
- 4 sitesAustralia
- Study dates
- 4 Dec 2025to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia4 sites, 4 recruiting
- Not yet recruiting
Royal Brisbane and Womens Hospital (QLD)
Brisbane, Queensland, 4010
- Not yet recruiting
Greenslope Hospital (QLD)
Brisbane, Queensland, 4101
- Recruiting
Frances Perry House (VIC)
Melbourne, Victoria
Sarah Price, 0409717760, sarah.price@thewomens.org.au
Megan Mathers, megan.mathers@mcri.edu.au
- Recruiting
Royal Womens Hospital (VIC)
Melbourne, Victoria
Anna Tottman, anna.tottman@thewomens.org.au
Megan Mathers, megan.mathers@mcri.edu.au
About this study
Official title: A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.
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.
Read the 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.
- Conditions
- Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay, Neonatal Intensive Care Unit, Breastfeeding
- Being tested
- Standard care Cow's milk based formula, Dietary Supplement: PDHM Pasteurised Donor Human Milk
- Keywords
- Pasteurised donor human milk, Donor breastmilk
- Medical subject headings
- Milk Hypersensitivity, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care Cow's milk based formulaOther
Also called Standard Care_Formula milk
Standard hospital care would be given as as per local unit policy at the site.
Dietary Supplement: PDHM Pasteurised Donor Human MilkDietary supplement
Also called PDHM_Donor milk
PDHM will be given to infants randomised to the intervention group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Standard care Cow's milk based formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From birth to 120 hours of life
Secondary outcomes (20)
Duration of hypoglycaemia (<2.6 mmol/L)
Length of time until 3 consecutive total blood glucose >2.6 mmol/L (hours) from randomization
Measured: From birth upto 120 hours of life
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.
Measured: From birth to 30 days after hospital discharge
Episodes of phlebotomy
By assessing the number of episodes of phlebotomy during initial hospital admission to discharge (infant).
Measured: From birth up to 120 hours of life
Hospital length of stay (infant)
Duration of hospital stay from birth to hospital discharge, measured in hours.
Measured: From birth up to initial hospital discharge, up to 90 days of life
Hospital re-admission within 30 days
By assessing the proportion of infants with hospital re-admission within 30 days of discharge
Measured: From birth to 30 days after discharge
Neonatal unit admission and length of stay (infant)
By assessing the proportion of infants admitted to the neonatal unit. For those admitted: the duration of admission (hours) will also be recorded.
Measured: From birth to initial hospital discharge, up to 90 days of life
Breast milk feeding
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
Measured: 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
Use of Formula feeding
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.
Measured: 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
Maternal mental health in the post-partum period GAD-7
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.
Measured: At 6 weeks and 6 months post delivery
Maternal mental health in the post-partum period using PHQ-9 survey
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.
Measured: At 6 weeks and 6 months post delivery
Maternal & Infant Health-related quality of life using AQoL-4D
The Assessment of Quality of Life Measure AQoL-4D questionnaire will be used to capture mother's and infants quality of life.
Measured: At 6 weeks and 6 months post delivery
Maternal & Infant Health-related quality of life using TANDI
The Toddler and Infant questionnaire will be used to capture infant health-related quality of life
Measured: At 6 weeks and 6 months post delivery
Infant growth up to 12 months
Infant weight at hospital discharge, 4, 8 and 12 months of age (self-reported)
Measured: At 4, 8 and 12 months of age
Maternal metabolic health
Maternal weight (self-reported)
Measured: At pre-birth, 6 and 12 months post delivery
Maternal metabolic health
By assessing maternal glucose tolerance test
Measured: At 6-8 weeks after delivery
Infant cow's milk allergy using Questionnaires
Using an electronic survey asking about the symptoms related to cow's milk allergy
Measured: At 6 and 12 months
Infant cow's milk allergy using SPT
More assessment will done using a skin prick test if required to confirm allergy status
Measured: At 6 and 12 months
Infant cow's milk allergy using OFC challenge
Infants with a positive skin test will be further invited for an oral food challenge assessment, if required, to confirm allergy status
Measured: At 6 and 12 months
Infant antibiotic use in the first 12-months of life
By assessing the parent's reports on the use of antibiotics
Measured: At 6 weeks, 6 and 12 months
Proportion of infants hospitalised with an infection in the first year of life
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
Measured: At 6 weeks, 6 and 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start4 Dec 2025
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled intervention trial - control and intervention arm
- Masking
- None (open label)
- Enrolment
- 1,444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Jennifer Koplin, PhD, Principal investigator, Child Health Research Centre, University Of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993103
- Sponsor's protocol ID
- 2024-607
- Other IDs
- 2024607
- Acronym
- PRESENT
- Status last verified
- Jan 2026
- First submitted
- 25 Mar 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All information collected during this study, including individual participant's personal health information, will be kept confidential and will not be shared with anyone outside the study unless required by law. Participants will not be named in any reports, publications, or presentations that may come from this study.
Publications
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.
PubMed 30716594Shah 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.
PubMed 30408811Forster 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.
PubMed 28589894Gertz 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.
PubMed 30767426De 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.
PubMed 26113051Clifford 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.
PubMed 35779010Clifford 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.
PubMed 33351688Urashima 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.
PubMed 31633778Halken 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.
PubMed 33710678Titmuss 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.
PubMed 35644889
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.
- ClinicalTrials.gov ID
- NCT06993103
- Acronym / sponsor ID
- PRESENT / 2024-607
- Conditions
- Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay, Neonatal Intensive Care Unit, Breastfeeding
- Keywords
- Pasteurised donor human milk, Donor breastmilk
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,444 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- 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 start
- 4 Dec 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 28 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled intervention trial - control and intervention arm
| Arm | Type | Receives |
|---|---|---|
| PDHM - Pasteurised donor human milk | Experimental | Dietary Supplement: Dietary Supplement: PDHM Pasteurised Donor Human MilkAll 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. |
| Standard Care | Active comparator | Other: Standard care Cow's milk based formulaAll 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 |
Who may qualify
- Ages
- 0 to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care Cow's milk based formulaAlso: Standard Care_Formula milkStandard hospital care would be given as as per local unit policy at the site. | Other | Standard Care |
| Dietary Supplement: PDHM Pasteurised Donor Human MilkAlso: PDHM_Donor milkPDHM will be given to infants randomised to the intervention group | Dietary supplement | PDHM - Pasteurised donor human milk |
Primary outcome
Proportion of infants admitted to neonatal unit for management of hypoglycaemia
Time frame: 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.
20 secondary outcomes
Duration of hypoglycaemia (<2.6 mmol/L)
Time frame: From birth upto 120 hours of life
Proportion of infants requiring IV access for dextrose
Time frame: From birth to 30 days after hospital discharge
Episodes of phlebotomy
Time frame: From birth up to 120 hours of life
Hospital length of stay (infant)
Time frame: From birth up to initial hospital discharge, up to 90 days of life
Hospital re-admission within 30 days
Time frame: From birth to 30 days after discharge
Neonatal unit admission and length of stay (infant)
Time frame: From birth to initial hospital discharge, up to 90 days of life
Breast milk feeding
Time frame: 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
Use of Formula feeding
Time frame: 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
Maternal mental health in the post-partum period GAD-7
Time frame: At 6 weeks and 6 months post delivery
Maternal mental health in the post-partum period using PHQ-9 survey
Time frame: At 6 weeks and 6 months post delivery
Maternal & Infant Health-related quality of life using AQoL-4D
Time frame: At 6 weeks and 6 months post delivery
Maternal & Infant Health-related quality of life using TANDI
Time frame: At 6 weeks and 6 months post delivery
Infant growth up to 12 months
Time frame: At 4, 8 and 12 months of age
Maternal metabolic health
Time frame: At pre-birth, 6 and 12 months post delivery
Maternal metabolic health
Time frame: At 6-8 weeks after delivery
Infant cow's milk allergy using Questionnaires
Time frame: At 6 and 12 months
Infant cow's milk allergy using SPT
Time frame: At 6 and 12 months
Infant cow's milk allergy using OFC challenge
Time frame: At 6 and 12 months
Infant antibiotic use in the first 12-months of life
Time frame: At 6 weeks, 6 and 12 months
Proportion of infants hospitalised with an infection in the first year of life
Time frame: At 6 weeks, 6 and 12 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Background: PubMed 30716594Griffith 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.
- Background: PubMed 30408811Shah 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.
- Background: PubMed 28589894Forster 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.
- Background: PubMed 30767426Gertz 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.
- Background: PubMed 26113051De 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.
- Background: PubMed 35779010Clifford 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.
- Background: PubMed 33351688Clifford 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.
- Background: PubMed 31633778Urashima 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.
- Background: PubMed 33710678Halken 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.
- Background: PubMed 35644889Titmuss 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.
- Individual participant dataSharing planned: No. All information collected during this study, including individual participant's personal health information, will be kept confidential and will not be shared with anyone outside the study unless required by law. Participants will not be named in any reports, publications, or presentations that may come from this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Koplin, PhD principal investigator
Child Health Research Centre, University Of Queensland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dietary Supplement: PDHM Pasteurised Donor Human Milk in people with Neonatal Hypoglycemia and Metabolic Complication, run by The University of Queensland at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Koplin, PhD (061+0400032577, j.koplin@uq.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of infants admitted to neonatal unit for management of hypoglycaemia (time frame: From birth to 120 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06993103, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.