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:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT06486194
Eligibility Criteria:
Inclusion criteria Phase 1A For University Hospital Southampton (UHS) milk bank donors
* Approved as a donor for the UHS milk bank through the usual process
* Be providing milk to UHS donor milk bank For mothers of infant inpatients
* Have an infant who is currently an inpatient in the neonatal unit, paediatric wards, paediatric cardiac ward, or paediatric intensive care unit
* Be providing breastmilk for their preterm or term born infant
* Have sufficient breast milk available such that providing 120ml breast milk for the study does not impact on the needs of their infant.
Inclusion criteria Phase 1B
* Approved as a donor for the UHS milk bank through the usual process
* Be providing milk to UHS donor milk bank
Exclusion criteria Phase 1A and 1B For mothers of infant inpatients
\- Mothers whose infants are inpatients and where there is a concern about adequacy of maternal milk supply to feed their infant
Inclusion Criteria Phase 2
* Birth weight ≥1kg and \<1.8 kg (so meet the ESPGHAN criteria for breast milk fortification)
* Be taking fully fortified enteral breast milk feeds (≥150 ml/kg/day of mothers or donor breast milk containing breast milk fortifier as per the manufacturer's instructions)
* Tolerating fully fortified breast milk feeds≥150 ml/kg/day for 48 hours
* No longer on parenteral nutrition.
Exclusion Criteria Phase 2
* Infants where there is a concern about mother's supply of breast milk being insufficient to meet demands (where donor milk is not being used to make up any shortfall);
* Known congenital metabolic disorder;
* Infant formula fed;
* Bilateral grade III or IV intraventricular haemorrhage;
* Any infant who has had gastrointestinal tract surgery;
* Refusal of consent;
* Refusal for the use of breast milk fortifier
* Birthweight \<1 kg
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
50 Years
Study:
NCT06486194
Study Brief:
Protocol Section:
NCT06486194