HMF preterm case studies
Research type
Research Study
Full title
Evaluating the Tolerance, Compliance, Acceptability and Safety of a New Human Milk Fortifier (NHMF) in preterm infants: a case study series
IRAS ID
287489
Contact name
Rebecca Stratton
Contact email
Sponsor organisation
Nutricia Ltd (UK)
Duration of Study in the UK
1 years, 2 months, 31 days
Research 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. Breast milk offers an array of benefits, but does not always provide enough nutrition (energy, protein and some micronutrients) for preterm infants who often have increased requirements for growth. Therefore, neonatal experts and evidence-based nutrition guidelines for preterm infants recommend breast milk supplementation with a multicomponent human milk fortifier (HMF) to support a growth rate consistent with intra-uterine growth rates.
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, available in 1.0g sachets and 200g tins, where each 4.0g serving provides 17kcal and 1.3g protein. When combined with breast milk at the recommended concentration (4.0g per 100ml), the fortified breast milk is estimated to provide 84kcal and 2.5g protein per 100ml.
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.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
20/SW/0158
Date of REC Opinion
10 Nov 2020
REC opinion
Further Information Favourable Opinion