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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Targeted breast milk fortification using preemie device
DeviceMother'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
Standard Breast milk fortification
Dietary supplementStandard multicomponent breast milk fortifier will be added to mother milk as per usual practice for preterm infants
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Targeted breast milk fortification using preemie deviceExperimental treatment 2 interventions
Group B: Standard FortificationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1: Accuracy of the Preemie system against reference laboratory International Standards Organization (ISO) methods.
Establish accuracy of the Preemie system in measuring the macronutrient content of human milk (fat in g/L, fatty acids in g/L, protein in g/L, carbohydrate in g/L, and energy in g/L) carried out using the Preemie system and determining the bias against the same measurements performed through validated reference laboratory methods; Accuracy study of the Preemie system by paired testing of at least 100 human breast milk samples using both the Preemie system and reference laboratory ISO methods As per the Clinical and Laboratory Standards (CLSI) reference standard EP09c, Measurement Procedure Comparison and Bias Estimation Using Patient Samples - 3rd Edition, 2018, the accuracy of the Preemie system compared to the reference laboratory will be assessed through regression analysis, method comparison (R2, slope, intercept calculations), and bias estimations at low, medium, and high levels of each analyte.
Time frame
6 months2
Phase 1: Precision of the Preemie system against reference laboratory ISO methods.
Establish precision/reproducibility of the Preemie sensor by assessing the standard deviation of measures of the macronutrient content of human breast milk (protein in g/L, Fat in g/L, carbohydrate in g/l) related to measurements collected by different operators and units Precision/reproducibility study of the Preemie system by paired testing of at least 5 human milk samples. As per the CLSI reference standard EP05-A3, Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - 3rd Edition, 2014, the Preemie system precision/reproducibility will be assessed by measuring the standard deviation between day, within run, between run, and in total, at each site, for each analyte.
Time frame
6 months3
Phase 2: Feasibility of recruiting infants to a study using Preemie system and associated NutriNTrack software to provide targeted individualised breast milk fortification in line with European recommendations.
Measure ability to recruit infants to study (recruitment success rates given as the percentage of parents giving consent of the total number approached)
Time frame
1 year4
Phase 2: Feasibility of using Preemie system and associated NutriNTrack software to provide targeted individualised breast milk fortification in line with European recommendations.
Measure ability to deliver intervention successfully (intervention compliance given as a percentage of infants randomised to targeted individualised breast milk fortification who received the intervention as intended)
Time frame
1 yearSecondary outcomes
1
Phase 2: Enteral macronutrient intakes
Compare enteral macronutrient (energy, carbohydrate, protein and fat) intake in g/kg/day as measured by the Preemie system in treated groups compared to non-treated groups during duration of treatment period.
Time frame
36 weeks corrected gestational age2
Phase 2: Enteral trace element intakes
Compare enteral trace elements (zinc, selenium and copper) intakes in mcg/kg/day as calculated based on measured milk intake in treated groups compared to non-treated groups during duration of treatment period.
Time frame
36 weeks corrected gestational age3
Phase 2: Enteral fat-soluble vitamin intakes
Compare fat-soluble vitamin (A, D, E and K) intake in units/kg/day as calculated based on measured milk intake in treated groups compared to non-treated groups during duration of treatment period.
Time frame
36 weeks corrected gestational age4
Phase 2: Enteral wate-soluble vitamin intakes
Compare water-soluble vitamin (C and B vitamins) intake in mcg/kg/day as calculated based on measured milk intake in treated groups compared to non-treated groups during duration of treatment period.
Time frame
36 weeks corrected gestational ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Southampton NHS Foundation Trust
Lead sponsor
Tellspec Ltd
Collaborator
Source ClinicalTrials.gov
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