BridgeMD
New treatment option for Neonatal Hypoglycemia
Official title Pasteurised Donor Human Milk Supplementation for Term Babies
ClinicalTrials.gov ID: NCT06993103
What this study is testing
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 48
You may be able to join 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
You likely can't join 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...
- Infant has received infant formula prior to randomisation.
- Infant admitted to neonatal intensive care prior to randomisation.
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Brisbane, Queensland, Australia
- Melbourne, Victoria, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 hours to 48 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brisbane, Queensland, Australia; Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.