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

Alexandria University

Status: Completed

Conditions: Nutrition Disorder, Child; Neurologic Disorder

Treatments: Dietary Supplement: Whey-Based Partially Hydrolyzed Formula; Dietary Supplement: received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines

Study type: Interventional

Funder types: Other

Identifiers

NCT06356103

0107060

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children aged from 2-6 years

2. undernourished children with NI (1 or more of the following signs for identification of undernutrition in the studied children:

   • weight for age z score <-2,
   • triceps skinfold thickness <10th centile for age,
   • mid-upper arm fat or muscle area <10th percentile for age,
   • faltering weight
   • failure to thrive.
   • physical signs of undernutrition such as decubitus skin problems and poor peripheral circulation

Exclusion criteria

• NI due to metabolic diseases

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Group I

Active Comparator group

Description:

received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines

Treatment:

Dietary Supplement: received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines

Group II

Active Comparator group

Description:

received 50% of their caloric requirements as WPHF and the other 50% as standard nutritional feeding

Treatment:

Dietary Supplement: Whey-Based Partially Hydrolyzed Formula