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Introduction The nutritional compositions of infant foods for special medical purposes (iFSMPs) are governed by the EU, and new regulations (2016/127; 2016/128) were implemented to ensure standardisation and implementation of latest nutritional recommendations, scheduled to take effect by February 2020. Amongst the changes required, nutrient minimum and maximum levels were redefined, as well as mandatory supplementation of docosahexaenoic acid (DHA). Anecdotal evidence from clinical practice suggests that changes to formulations, minor or otherwise, may affect tolerance and acceptance in infants taking iFSMPs, especially those with complex medical conditions and backgrounds. A case-study series was conducted to evaluate iFSMPs reformulated by Nutricia Ltd to understand any possible impact on patient care. Aim A multi-centre case-study series was conducted in infants and children who took iFSMPs manufactured by Nutricia Ltd for a range of clinical conditions. Gastro-intestinal tolerance, acceptance and compliance were evaluated over 28 days in each case-study. Methods From 17 paediatric centres across the UK, 44 infants and children were recruited [mean age 16.5 m; range 1.5–87], receiving one of the following iFSMPs prescribed for nutrition support relevant to their clinical condition: Infatrini (n=9), Infatrini Peptisorb (n=3), Neocate LCP (n=9), Neocate Syneo (n=1), Kindergen (n=4), Monogen (n=5), Energivit (n=4), Locasol (n=4), Galactomin 19 (n=1), PKU Anamix Infant (n=4). Mean intake of baseline iFSMP was 683±275 ml (which met 97% of prescribed daily volume), of which n=16 administered iFSMPs via enteral feeding tubes (the remaining orally). The managing Dietitian determined the prescribed daily volume of the reformulated iFSMP. Medical history was recorded at baseline, and growth, gastrointestinal tolerance, compliance and acceptance was measured at baseline and end of case-study. Results Forty patients completed the 28-day evaluation (n=4 did not due to medical and other reasons, days on case-study ranged between 1–17). Gastrointestinal tolerance remained stable in the majority of case studies (n=41 including n=1 drop out), and any deviations were not attributed to the reformulated iFSMPs. For the patients that completed the 28-day evaluation, compliance remained stable (n=33), and any reduction was related to increased complementary feeding or medical reasons. Mean intake of reformulated iFSMP was 579±254 ml (which met 91% of prescribed daily volume), where the majority of patients directly transitioned onto the reformulation (n=41). No deterioration in medical conditions or growth were reported as a result of using the reformulated iFSMPs during any of the case studies. Furthermore, caregiver and HCP satisfaction was positively recorded in 89% of case studies. Conclusion This multi-centre, case-study series demonstrates that the minor reformulation of iFSMPs manufactured by Nutricia Ltd in line with the Commission Delegated Regulations (2016/127; 2016/128) to amend nutrient levels and include DHA are well tolerated, accepted and complied with in infants and children with various medical backgrounds. Furthermore, the reformulated iFSMPs continued to support growth and achieved positive caregiver and HCP satisfaction which is paramount to patient care. The reformulated iFSMPs used in this case study series have since been implemented into clinical practice in the UK, with support from Nutricia Ltd, and are now widely accepted. |
