Preemie Milk Analyser Validation Study

NCT06486194 | Not Yet Recruiting

• 1 other identifier: CHI1219
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Phase 2: Enteral macronutrient intakes

  36 weeks corrected gestational age

• Phase 2: Enteral trace element intakes

  36 weeks corrected gestational age

• Phase 2: Enteral fat-soluble vitamin intakes

  36 weeks corrected gestational age

• Phase 2: Enteral wate-soluble vitamin intakes

  36 weeks corrected gestational age

• Phase 2: Enteral electrolyte intakes

  36 weeks corrected gestational age

Study Arms (2)

Targeted breast milk fortification using preemie device

EXPERIMENTAL

Mother's breast milk (MBM) or Donor Breast Milk (DBM) for use in a day's milk feeds will be measured using the Preemie sensor every 2-3 days, results recorded, and the amounts of breast milk fortifier (BMF), protein supplement, carbohydrate supplement and fat supplements needed to be added in order for that sample of milk to meet current 2022 European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) enteral nutrient intake recommendations calculated by the Preemie Sensor NutriNTrack software. Feeds will be made up in batches of 24hrs worth of feeds each day based on these calculations and the resulting supplement amounts used for the next 2-3 days until another sample of MBM is analysed, in line with previous work by Rochow et al

Device: Targeted breast milk fortification using preemie device; Dietary Supplement: Standard Breast milk fortification

Standard Fortification

ACTIVE COMPARATOR

Mother's breast milk (MBM) or Donor Breast Milk (DBM) for use in a day's milk feeds will be measured using the Preemie sensor every 2-3 days and results recorded. Breast milk will then be fortified in the standard way according to the manufacturer's recommendations, which assume a standard macronutrient content of the milk.

Dietary Supplement: Standard Breast milk fortification

Interventions

Targeted breast milk fortification using preemie device 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

Targeted breast milk fortification using preemie device

Standard Breast milk fortification DIETARY_SUPPLEMENT

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

Standard Fortification; Targeted breast milk fortification using preemie device

Eligibility Criteria

• Age: 0 Days - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Approved as a donor for the UHS milk bank through the usual process
• Be providing milk to UHS donor milk bank

You may not qualify if:

• \- Mothers whose infants are inpatients and where there is a concern about adequacy of maternal milk supply to feed their infant
• 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.
• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• Tellspec Ltd: collaborator

Study Sites (1)

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

MeSH Terms

Conditions

Premature Birth; Breast Milk Expression; Infant Nutrition Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Feeding; Feeding Behavior; Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Mark J Johnson, PhD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew Guy

CONTACT

+442381205146; andrew.guy@uhs.nhs.uk

Sharon Davies-Dear

CONTACT

+442381205146; sharon.davies-dear@uhs.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1: Validation of the Preemie sensor, encompassing 2 different analytical studies for assessing the accuracy (1) and the precision/reproducibility (2) of the system Phase 2: Open label randomised controlled trial to test use of Preemie ecosystem in clinical practice for the delivery of targeted individualised breast milk fortification

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)