Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula On Undernourished Neurologically Impaired Children

Neurologic Disorder Clinical Trial

Official title:

Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula On Undernourished Neurologically Impaired Children: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06356103
• Other study ID #: 0107060
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: February 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 15, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Nervous System Diseases
• Neurologic Disorder
• Nutrition Disorder, Child
• Nutrition Disorders

Intervention

Dietary Supplement:
• High Caloric Whey-Based Partially Hydrolyzed Formula
Peptamen junior, 100 kcal/100 ml (Nestlé Health Science, Vevey, Switzerland).
• nutritional feeding according to ESPGHAN guidelines
protein and micronutrient requirements according to the recommended dietary allowance (RDA)

Locations

Country	Name	City	State
Egypt	Alexandria University Children Hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI).	Identify the Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula on the weight in Kilogram measured using the double weighing method (weight of the parent subtracted from the combined weight of parent and child) on a digital scale.	6 months
Primary	To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in centimeter in undernourished children with neurological impairment (NI).	Identify the Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula on the height/length in Centimeter measured by a stadiometer. In children with joint contractions, spasticity, and/or scoliosis, the length was measured by segmental length measurements using sliding calipers. Then the length was estimated by simple equations such as knee-heel length (L = (2.69 x KH) + 24.2), tibia length (L = (3.26 x TL) + 30.8).	6 months
Primary	To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the body mass index (BMI) in children with neurological impairment (NI).	Identify the Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula on the body mass index (BMI) calculated as [weight in kg]/ [height in m]2	6 months
Primary	To compare the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in centimeter in undernourished children with neurological impairment (NI)	Identify the Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula on the head circumference (HC) in Centimeter measured by non-stretchable tape	6 months
Secondary	To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI) for 3 and 6 months	Follow up the Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula on the weight in Kilogram measured using the double weighing method (weight of the parent subtracted from the combined weight of parent and child) on a digital scale for 3 and 6 months	6 months
Secondary	To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the height/length in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months	Follow up the Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula on the height/length in Centimeter measured by a stadiometer. In children with joint contractions, spasticity, and/or scoliosis, the length was measured by segmental length measurements using sliding calipers. Then, the length was estimated by simple equations such as knee-heel length (L = (2.69 x KH) + 24.2), tibia length (L = (3.26 x TL) + 30.8) for 3 and 6 months.	6 months
Secondary	To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus on the body mass index in undernourished children with neurological impairment (NI) for 3 and 6 months	Follow up the Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula on the body mass index (BMI) calculated as [weight in kg]/ [height in m]2 for 3 and 6 months	6 months
Secondary	To follow up the efficacy of high-caloric whey-based partially hydrolyzed formula versus standard feeding on the head circumference in Centimeter in undernourished children with neurological impairment (NI) for 3 and 6 months	Follow up the Efficacy Of High Caloric Whey-Based Partially Hydrolyzed Formula on the head circumference (HC) in Centimeter measured by non-stretchable tape for 3 and 6 months	6 months