HMF Preterm Case Studies

NCT05057390 | Completed

• 1 other identifier: NHMF2020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

Brief Summary

Nutritional requirements in preterm infants can be elevated, as a result of complex clinical circumstances including infections, immaturity of the gastrointestinal tract and invasive treatments, such as surgery which can place a greater metabolic demand on the body. Furthermore, these circumstances can impact an infant's ability to meet nutritional requirements and achieve optimum growth through normal feeding alone. Most preterm infants may need specialist care by the neonatal team during hospital admission and post-discharge, which includes enteral nutritional support. Human Milk Fortifier (HMF) have become a component of the routine clinical care of preterm infants on neonatal units. There is published evidence to support this practice as being safe and effective. A multitude of trials have demonstrated improvements in weight, length and head circumference following interventions using HMF, compared to non-supplemented cohorts, and benefits have been observed at long term follow up. Whilst HMF is used routinely in neonatal units, there is little clinical evidence for using them beyond discharge in the community, although this is widely accepted in practice. Nutricia have developed a new HMF (NHMF) that can be provided for use in the community. This series of case-studies will evaluate the tolerance, compliance, acceptability and safety of the NHMF, in 15 preterm infants. Each case study will last at least 28 days, including at least 7 days in the community setting. The case studies will be conducted across multiple specialist neonatal centres in the UK, to meet the UK ACBS requirements.

Conditions

Preterm Infants

Outcome Measures

Primary Outcomes (1)

• Gastro-intestinal tolerance

  Gastro-intestinal (GI) tolerance will be recorded by the investigating Dietitian at the above-mentioned time-points. GI tolerance will be recorded using a standardised questionnaire, to be completed by the investigating Dietitian with the parent/caregiver, as appropriate. Parents/caregivers will be asked to recall the infant's symptoms in the past 24 hours to the investigating Dietitian, and as an average over the case study period, at each assessment point.

  Baseline (Start of intervention) - End of case study (4 weeks administration)

Secondary Outcomes (3)

• Compliance

  Baseline (Start of intervention) - End of case study (4 weeks administration)

• Anthropometrics

  Baseline (Start of intervention) - End of case study (4 weeks administration)

• Safety (adverse events)

  Baseline (Start of intervention) - End of case study (4 weeks administration)

Study Arms (1)

New Human Milk Fortifier

EXPERIMENTAL

From the Baseline (start of intervention) each patient will receive the case study product for at least 4 weeks (28 days), with at least 1-week administration in the community.

Dietary Supplement: New Human Milk Fortifier (NHMF)

Interventions

New Human Milk Fortifier (NHMF) DIETARY_SUPPLEMENT

The case study product will be added to human milk during the hospitalization and will continue after discharge for at least 1 week (7 days), to obtain community data. NHMF prescription will be specified on an individual basis by the investigating Dietitian responsible for the infant's nutritional management. The intervention period will end when the infant does not require NHMF (according to local neonatal guidelines and/or clinical indication). The case study product will be labelled specifically for the case study and will be available in a powder format. Full preparation, storage and safety instructions will be given to the parent/caregiver by the investigating Dietitian before commencing the case study product to ensure its correct and safe use.

New Human Milk Fortifier

Eligibility Criteria

• Age: Up to 37 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants fed own mother's milk (or donor human milk) requiring HMF (as decided by the investigator)
• Born before 37 weeks completed gestational age and \>1 dropped centile since birth requiring HMF (as decided by the investigator)
• Tolerating adequate volume of enteral nutrition
• Expected to require HMF after discharge (minimum 4.0g NHMF per day at discharge)
• Written or electronic informed consent from parent/caregiver

You may not qualify if:

• Anticipated short term use of HMF leading to discontinuation of HMF after hospital discharge
• Presence of any relevant proven or suspected chromosomal anomaly or genetic syndrome, any gastrointestinal malformation/compromise, including Necrotising enterocolitis (NEC) (defined as Bell's stage two or higher), metabolic disorder, or congenital central nervous system malformation that may impact tolerance of enteral feeding
• Failure to establish enteral nutrition and requiring full parenteral nutrition
• Participation in other studies within 1 month prior to the entry of this study
• Known allergy to any of the study product ingredients, including cow's milk, fish and egg
• Concern or issues around the breast milk supply from mother of preterm infant at enrolment
• Investigator concerns around willingness/ability of the parent/caregiver to comply with protocol requirements and/or handle and store NHMF appropriately

Sponsors & Collaborators

• Nutricia UK Ltd: lead

Study Sites (4)

Bradford Teaching Hospitals

Bradford, United Kingdom

Location

Bristol University Hospitals

Bristol, BS2 8BJ, United Kingdom

Location

Norfolk & Norwich University Hospitals

Norwich, NR4 7UY, United Kingdom

Location

University Hospitals Plymouth

Plymouth, United Kingdom

Location

Study Officials

• Rebecca Stratton

  Nutricia UK Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 27, 2021
• Study Start: December 16, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

GB (4)