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Clinical Trial Summary

Purpose: Undernutrition is common in neurologically impaired children. It increases the burden of comorbidities and affects the quality of life of these children. It must be recognized and treated as early as possible. This study aimed primarily to compare the efficacy of high-caloric whey-based partially hydrolyzed formula (HC-WPHF) versus standard feeding on the nutritional status reflected by growth parameters and feeding tolerance in undernourished children with neurological impairment (NI). The secondary aim was to compare the change in these parameters after using HC-WPHF for 3 and 6 months.


Clinical Trial Description

This prospective randomized controlled study was conducted over 6 months on children with NI aged from 2- 6 years. Patients were divided into 2 groups: a group received standard nutritional feeding according to ESPGHAN guidelines (group I) and the second group received 50% of their caloric requirements as HC-WPHF and the other 50% standard nutritional feeding (group II). At the start of the study, detailed clinical and nutritional history was recorded for all children in the two groups. Anthropometric measurements were measured, and standard deviation was calculated for all parameters. Symptoms of feeding intolerance and frequency of chest infections were assessed and reported. These parameters were reassessed after 3 months and after 6 months of nutritional intervention and compared between the 2 groups ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06356103
Study type Interventional
Source Alexandria University
Contact
Status Completed
Phase N/A
Start date June 1, 2022
Completion date July 15, 2023

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