MedTrace Logo

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

NCT06356103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-08-19

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Alexandria University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2022-12-31
Completion
2023-07-15

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06356103 on ClinicalTrials.gov