NCT06356103

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

Summary

Purpose: 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 primarily to compare the efficacy of whey-based partially hydrolyzed formula (WPHF) versus isocaloric polymeric formula on the nutritional status reflected by growth parameters and feeding tolerance in 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

Detailed description

This prospective open-label randomized study was conducted over 6 months on children with NI aged 2- 6 years. Patients were divided into two groups: one group received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines (group I), the second group received 50% of their caloric requirements as WPHF, and the other 50% standard nutritional feeding according to ESPGHAN guidelines (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 the Z score 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 6 months of nutritional intervention and compared between the two groups.

Conditions

• Nutrition Disorder, Child
• Neurologic Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Whey-Based Partially Hydrolyzed Formula	Peptamen junior, 100 kcal/100 ml (Nestlé Health Science, Vevey, Switzerland).
DIETARY_SUPPLEMENT	received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines	protein and micronutrient requirements according to the recommended dietary allowance (RDA)

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-12-31
• Completion: 2023-07-15
• First posted: 2024-04-10
• Last updated: 2024-08-19

Locations

1 site across 1 country: Egypt