Whey-Based Partially Hydrolyzed Formula Versus Polymeric Formula On Undernourished Neurologically Impaired Children: Open-Label Randomized Study

Background: Undernutrition is common in neurologically impaired children. It increases the burden of comorbidities and affects the quality of life of these children. This study aimed to compare the efficacy of whey-based partially hydrolyzed formula (WPHF) versus isocaloric polymeric formula on the nutritional status of undernourished children with neurological impairment (NI). The secondary aim was to follow up on the changes in these parameters after using WPHF for 3 and 6 months. Methods: In this 6-month prospective, open-label, randomized study, children with NI aged 2–6 years were assigned to two groups. Group I received 50% of their caloric needs as an isocaloric polymeric formula and 50% of their standard nutritional feeding, as per ESPGHAN guidelines. Group II received 50% of their caloric needs as WPHF, with the remaining 50% from standard feeding. Anthropometric measurements, feeding intolerance symptoms, and chest infection frequency were assessed at baseline, 3 months, and 6 months. Results: A total of 100 children (50 per group) were included, with cerebral palsy being the most common cause of NI. After 3 months, Group II showed significant improvement in anthropometric measures and fewer symptoms of feeding intolerance. These benefits were further enhanced after 6 months of continued WPHF use. Conclusion: In undernourished children with NI, WPHF significantly improves nutritional status, growth parameters, and feeding tolerance compared to the standard polymeric formula. Notable improvements were observed within 3 months and increased with prolonged intervention. This study was registered at ClinicalTrial.gov (ID: NCT06356103) on 16th March 2024. “Retrospectively registered. https://register.clinicaltrials.gov/prs/app/template/EditRecord.vm?epmode=View&listmode=Edit&uid=U00076LH&ts=62&sid=S000EAYY&cx=-bryze2