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

August 16, 2024 updated by: Alexandria University
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 23445
        • Alexandria University Children Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group I
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
protein and micronutrient requirements according to the recommended dietary allowance (RDA)
Active Comparator: Group II
received 50% of their caloric requirements as WPHF and the other 50% as standard nutritional feeding
Dietary supplement: Whey-Based Partially Hydrolyzed Formula
Peptamen junior, 100 kcal/100 ml (Nestlé Health Science, Vevey, Switzerland).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 6 months
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).
Time Frame: 6 months
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).
Time Frame: 6 months
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)
Time Frame: 6 months
Identify the Efficacy Of Whey-Based Partially Hydrolyzed Formula on the head circumference (HC) in Centimeter measured by non-stretchable tape
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 6 months
Follow up 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 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
Time Frame: 6 months
Follow up 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) 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
Time Frame: 6 months
Follow up the Efficacy Of 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
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
Time Frame: 6 months
Follow up the Efficacy Of Whey-Based Partially Hydrolyzed Formula on the head circumference (HC) in Centimeter measured by non-stretchable tape for 3 and 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0107060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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