Status:
NOT_YET_RECRUITING
Preemie Milk Analyser Validation Study
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
Tellspec Ltd
Conditions:
Pre-Term
Breast Milk Expression
Eligibility:
All Genders
Up to 50 years
Phase:
NA
Brief Summary
This study aims to test and validate the Preemie Ecosystem- a new device and associated software package for measuring the nutrient (fat, protein and carbohydrate) content of the breast milk of the mo...
Detailed Description
This is a single centre study taking place in a neonatal intensive care unit which is a regional referral centre for neonatal surgery and other tertiary specialities. The centre has well established p...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06486194
Start Date
July 1 2024
End Date
July 1 2026
Last Update
July 3 2024
Active Locations (1)
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1
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, United Kingdom, SO16 6YD