Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486194
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-10
Brief Title:
Preemie Milk Analyser Validation Study
Sponsor:
University Hospital Southampton NHS Foundation Trust
Organization:
University Hospital Southampton NHS Foundation Trust
Study Overview
Official Title:
Analytical Validation and Clinical Testing of the Preemie System for Analysis and Calculation of Targeted Fortification of Mothers Breast Milk for Preterm Infants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mothers breast milk is different and varies from day to day so each mothers 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 mothers 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 mothers 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
The aim of this study is to first test and validate the accuracy of the Preemie device for measuring the nutritional content of mothers 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 mothers 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
Detailed Description:
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 precisionreproducibility 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 carbohydratesugar 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 precisionreproducibility 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 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 results recorded MBM or DBM will then be fortified in the standard way according to the manufacturers 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
Phase 1 Validation of the Preemie sensor encompassing 2 different analytical studies for assessing the accuracy 1 and the precisionreproducibility 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 carbohydratesugar 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 precisionreproducibility 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 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 results recorded MBM or DBM will then be fortified in the standard way according to the manufacturers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None