Analytical Validation and Clinical Testing of the Preemie System for Analysis and Calculation of Targeted Fortification of Mother's Breast Milk for Preterm Infants

简要总结

详细描述

This is a single centre study taking place in a neonatal intensive care unit which is a regional referral centre for neonatal surgery and other tertiary specialities. The centre has well established policies for nutritional care, inducing the routine use of breast milk fortifier, and a track record in research into the nutrition and growth of preterm infants. It will have 2 phases: 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 The methods used in each phase are as follows: PHASE 1: Validation of Preemie Sensor Part A - Mothers currently expressing breast milk and meeting the inclusion criteria will be approached to take part in the study. They will be asked to provide 120ml of their breast milk which will be divided into a 20ml sample for use with the Preemie system and a 100ml sample for formal laboratory testing. The 20ml will be divided into ten smaller 2ml samples, and these will have their nutrient content (energy, fat, carbohydrate/sugar and protein) measured each day (in triplicate) using the Preemie sensor over a five day period and results recorded. The 100ml sample will be sent away to an independent third-party external laboratory to have its nutrient content (energy, fat, carbohydrate and protein) measured using standardised laboratory methods and results returned back to the study team. The results from the 2 systems will then be compared and the Preemie sensor assessed for accuracy. Part B - 5 mothers currently expressing milk and donating to Southampton Milk bank will be approached to take part in the study and asked to provide 170ml of their milk which will be divided into a 100ml sample for formal laboratory testing (see above). For reproducibility tests, the 5 milk samples (30 aliquots of 2 mL per sample for running the test, and 5 aliquots serving as back-up, for a total of 70 ml per sample) will be analysed in 3 different rooms, by 3 different operators, using independent Preemie units, over the 5-day precision study. The Preemie precision/reproducibility will be then assessed by measuring the standard deviation between day, within run, between run, and in total, at each site, for each analyte. For purposes of this phase of the study a "human breast milk sample" is one provided by a mother from a single expression. A mother may provide more than one sample if her milk supply allows this (see inclusion criteria) but samples should be at least 3 weeks apart. Purposive sampling will be used to ensure that the source of the samples is spread equally across the following 3 groups: * Mothers of preterm infants born before 37 weeks gestation * Mothers of term infants less than 8 weeks old * Mothers of term infants more than 8 weeks old 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 This phase will see if it is possible to recruit to a trial and deliver targeted fortification of breast milk for infants on the Neonatal Intensive Care Unit (NICU) to improve their growth and metabolism. 30 preterm infants will be recruited and randomised (chosen at random using a computer) to receive either targeted fortification or standard fortification. In the targeted fortification group, the nutritional content (energy, fat, carbohydrate and protein) of mothers breast milk (MBM) or Donor Breast Milk (DBM) for use in a days milk feeds will be measured using the Preemie sensor every 2-3 days, and the amounts of breast milk fortifier (BMF), Protein supplements, carbohydrate supplements and fat supplements needed to be added in order for that sample of milk to meet current 2022 European recommendations nutritional intake for preterm infants 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. This approach is in line with the research of other groups who have demonstrated this approach to be safe (using a different milk analyser). In the Standard fortification group Mother's breast milk (MBM) or Donor Breast Milk (DBM) for use in a days milk feeds will be measured using the Preemie sensor every 2-3 days and results recorded. MBM or DBM will then be fortified in the standard way according to the manufacturer's recommendations, which assume a standard macronutrient content of the milk The allocated fortification approach (targeted or standardised) will be continued until the infant no longer requires fortification (eg moves onto formula milk) or reaches 34 weeks (when they would begin to have some breast feeds), is transferred to another hospital, or discharged home At the end of the study the two sets of infants will be compared in terms of nutrient intakes and growth. Staff involved in delivering the Targeted Fortification will also be asked to provide feedback on the ease of use of the Preemie Ecosystem through semi-structured interviews and focus groups. Staff may also be observed by research staff using the machine in order to understand any issues and improve ease of use and user experience.

主要结局

次要结局

• Phase 2: Urea as a serum marker of nutritional status(36 weeks corrected gestational age)
• Phase 2: Enteral macronutrient intakes(36 weeks corrected gestational age)
• Phase 2: Enteral wate-soluble vitamin intakes(36 weeks corrected gestational age)
• Phase 2: Ease of use of Preemie device(1 year (end of study))
• Phase 2: Head Growth(36 weeks corrected gestational age)
• Phase 2: Enteral fat-soluble vitamin intakes(36 weeks corrected gestational age)
• Phase 2: Length Growth(36 weeks corrected gestational age)
• Phase 2: Neonatal morbidities(36 weeks corrected gestational age)
• Phase 2: Weight Gain(36 weeks corrected gestational age)
• Phase 2: Albumin as a serum marker of nutritional status(36 weeks corrected gestational age)
• Phase 2: Alkaline Phosphatase (ALP) as a serum marker of nutritional status(36 weeks corrected gestational age)
• Phase 2: Enteral trace element intakes(36 weeks corrected gestational age)
• Phase 2: Enteral electrolyte intakes(36 weeks corrected gestational age)
• Phase 2: Feed intolerance(36 weeks corrected gestational age)