Preemie Milk Analyser Validation Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-50
SponsorUniversity Hospital Southampton NHS Foundation Trust

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Targeted breast milk fortification using preemie device
  • Standard Breast milk fortification

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators