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Clinical Trial 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.

Clinical Trial Description


Study Design

Related Conditions & MeSH terms

NCT number NCT05057390
Study type Interventional
Source Nutricia UK Ltd
Contact Marta Delsoglio
Phone +44 7920 530707
Email [email protected]
Status Recruiting
Phase N/A
Start date December 16, 2020
Completion date December 31, 2022

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