Preemie Milk Analyser Validation Study
NCT Number: NCT06486194
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pre-Term|Breast Milk Expression|Nutrition Disorder, Infant
Interventions: DEVICE: Targeted breast milk fortification using preemie device|DIETARY_SUPPLEMENT: Standard Breast milk fortification
Sponsor: University Hospital Southampton NHS Foundation Trust
Collaborators: Tellspec Ltd
Sex: ALL
Age: CHILD, ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-01
Completion Date: 2026-07-01
Locations: University Hospital Southampton NHS Foundation Trust, Southampton, Hampshire, SO16 6YD, United Kingdom

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.

Primary Outcome Measures: 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., 6 months|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., 6 months|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), 1 year|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), 1 year
Secondary Outcome Measures: 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., 36 weeks corrected gestational age|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., 36 weeks corrected gestational age|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., 36 weeks corrected gestational age|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., 36 weeks corrected gestational age|Phase 2: Enteral electrolyte intakes, Compare enteral electrolytes (sodium, potassium, magnesium, phosphate, calcium) intake in mmol/kg/day as calculated based on measured milk intake in treated groups compared to non-treated groups during duration of treatment period., 36 weeks corrected gestational age|Phase 2: Feed intolerance, Establish days of feed intolerance in each group (defined as number of days enteral feed was withheld for =\>12 hours due to concerns about nasogastric aspirate colour or volume, vomiting, abdominal distension, stooling or vomiting) as a proportion of the total number of days on which standard or targeted individualised breast milk fortification was included in the feed and compare between groups, 36 weeks corrected gestational age|Phase 2: Neonatal morbidities, Compare rates of major neonatal morbidity between groups, consisting of necrotising enterocolitis (NEC), bronchopulmonary dysplasia (BPD, defined as requirement for oxygen beyond 36 weeks corrected gestational age), and culture positive sepsis., 36 weeks corrected gestational age|Phase 2: Ease of use of Preemie device, Obtain feedback from clinical staff on the process of targeted fortification using the Preemie sensor and software, including ease of use, time taken and complexity, clinical relevance, etc, 1 year (end of study)|Phase 2: Weight Gain, Change in standard deviation score for weight (in kg) between birth and 36 weeks corrected gestational age, 36 weeks corrected gestational age|Phase 2: Head Growth, Change in standard deviation score for head circumference (in cm) between birth and 36 weeks corrected gestational age, 36 weeks corrected gestational age|Phase 2: Length Growth, Change in standard deviation score for length (in cm) between birth and 36 weeks corrected gestational age, 36 weeks corrected gestational age|Phase 2: Urea as a serum marker of nutritional status, Compare mean serum urea (mmol/L) each week of the study between groups, 36 weeks corrected gestational age|Phase 2: Albumin as a serum marker of nutritional status, Compare mean serum albumin urea (g/L) each week of the study between groups, 36 weeks corrected gestational age|Phase 2: Alkaline Phosphatase (ALP) as a serum marker of nutritional status, Compare mean serum alkaline phosphatase (U/L) each week of the study between groups, 36 weeks corrected gestational age