Preemie Milk Analyser Validation Study

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 mothers of premature babies. This is potentially useful, as premature babies have higher nutritional requirements than babies born at term near their due date. At the moment, a nutritional supplement called breast milk fortifier is added to breast milk in standard amounts to improve its nutritional content and help premature babies grow. However, we know that each mother's breast milk is different, and varies from day to day, so each mother's milk may require more or less of such supplements in order to meet European recommendations for the nutrient intake.

The aim of this study is to first test and validate the accuracy of the Preemie device for measuring the nutritional content of mother's breast milk, using milk donated to the local donor milk bank and from mothers of babies currently on the neonatal unit. Next, once this is complete, the aim is to demonstrate it is feasible to use the Preemie device to enable fortification of mother's milk on an individualised basis for a small group of premature babies. The growth and nutrient intakes of these babies will be compared to another group who are cared for using the standard fortification approach.

The results of this study will be used to gain "Conformité Européenne" (CE) certification of the Preemie device and software.

Conditions

• Pre-Term
• Breast Milk Expression
• Nutrition Disorder, Infant

Interventions

DEVICE

Targeted breast milk fortification using preemie device

Mother's breast milk will have additional macronutrient added to it based on analysis with the Preemie device, to ensure it meets current European recommendations for nutrient intakes for preterm infants

DIETARY_SUPPLEMENT

Standard Breast milk fortification

Standard multicomponent breast milk fortifier will be added to mother milk as per usual practice for preterm infants

Sponsors & Collaborators

• Tellspec Ltd

  collaborator UNKNOWN

• University Hospital Southampton NHS Foundation Trust

  lead OTHER

Principal Investigators

• Mark J Johnson, PhD · University Hospital Southampton NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2026-03-01

Completion

2026-07-01

Countries

• United Kingdom

Study Locations