Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT06993103
Eligibility Criteria:
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.
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Hours
Maximum Age:
48 Hours
Study:
NCT06993103
Study Brief:
Protocol Section:
NCT06993103