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

NCT06356103 | Completed

• 1 other identifier: 0107060
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Nutrition Disorder, Child; Neurologic Disorder

Keywords

Neurological Impairment; Children; Partially Hydrolyzed Formula

Outcome Measures

Primary Outcomes (4)

• To compare the efficacy of whey-based partially hydrolyzed formula versus standard feeding on the weight in kilogram in undernourished children with neurological impairment (NI).

  Identify the Efficacy Of 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

• To compare the efficacy of 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 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

• To compare the efficacy of whey-based partially hydrolyzed formula versus standard feeding on the body mass index (BMI) in children with neurological impairment (NI).

  Identify the Efficacy Of Whey-Based Partially Hydrolyzed Formula on the body mass index (BMI) calculated as \[weight in kg\]/ \[height in m\]2

  6 months

• To compare the efficacy of 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 Whey-Based Partially Hydrolyzed Formula on the head circumference (HC) in Centimeter measured by non-stretchable tape

  6 months

Secondary Outcomes (4)

• To follow up the efficacy of 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

  6 months

• To follow up the efficacy of 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

  6 months

• To follow up the efficacy of whey-based partially hydrolyzed formula versus on the body mass index in undernourished children with neurological impairment (NI) for 3 and 6 months

  6 months

• To follow up the efficacy of 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

  6 months

Study Arms (2)

Group I

ACTIVE COMPARATOR

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

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

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

Dietary Supplement: Whey-Based Partially Hydrolyzed Formula

Interventions

Whey-Based Partially Hydrolyzed Formula DIETARY_SUPPLEMENT

Peptamen junior, 100 kcal/100 ml (Nestlé Health Science, Vevey, Switzerland).

Group II

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

protein and micronutrient requirements according to the recommended dietary allowance (RDA)

Group I

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged from 2-6 years
• 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

You may not qualify if:

• NI due to metabolic diseases

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Children Hospital

Alexandria, 23445, Egypt

Location

MeSH Terms

Conditions

Child Nutrition Disorders; Nervous System Diseases; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Randomized Controlled Study

Study Record Dates

• First Submitted: March 16, 2024
• First Posted: April 10, 2024
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: July 15, 2023
• Last Updated: August 19, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)