HMF Preterm Case Studies

NCT ID: NCT05057390

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-16
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

New Human Milk Fortifier

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.

Group Type: EXPERIMENTAL

New Human Milk Fortifier (NHMF)

Intervention Type: 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.

Interventions

New Human Milk Fortifier (NHMF)

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia UK Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca Stratton

Role: STUDY_CHAIR

Nutricia UK Ltd

Locations

Bradford Teaching Hospitals

Bradford, , United Kingdom

Bristol University Hospitals

Bristol, , United Kingdom

Norfolk & Norwich University Hospitals

Norwich, , United Kingdom

University Hospitals Plymouth

Plymouth, , United Kingdom

Countries

United Kingdom

Other Identifiers

NHMF2020

Identifier Type: -

Identifier Source: org_study_id