Nutrition Disorder, ChildNCT06356103

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

A study testing Whey-Based Partially Hydrolyzed Formula and received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines in people with Nutrition Disorder, Child and Neurologic Disorder, run by Alexandria University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 6 years
Conditions the study is for: Nutrition Disorder, Child, Neurologic Disorder
What is being tested?: Whey-Based Partially Hydrolyzed Formula and received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteEgypt
Study dates: 1 Jun 2022to 15 Jul 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

NI due to metabolic diseases

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Alexandria University Children Hospital
Alexandria, 23445

Other trials in Egypt

About this study

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

Read the 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.

Conditions: Nutrition Disorder, Child, Neurologic Disorder
Being tested: Whey-Based Partially Hydrolyzed Formula, received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines
Keywords: Neurological Impairment, Children, Partially Hydrolyzed Formula
Medical subject headings: Child Nutrition Disorders, Nervous System Diseases, Neurologic Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Whey-Based Partially Hydrolyzed FormulaDietary supplement
Peptamen junior, 100 kcal/100 ml (Nestlé Health Science, Vevey, Switzerland).
received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelinesDietary supplement
protein and micronutrient requirements according to the recommended dietary allowance (RDA)

Study groups in NCT06356103
Study group	Role	What they receive
Group I	Active comparator	received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines Receives: 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 Receives: Dietary Supplement: Whey-Based Partially Hydrolyzed Formula

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
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
Measured: 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
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.
Measured: 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
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
Measured: 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
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
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202215 Jul 2023

First posted10 Apr 2024
Study start1 Jun 2022
Primary completion31 Dec 2022
Study completion15 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nutrition Disorder, ChildStudies of the same condition, open and under way.
More trials run by Alexandria UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: A Randomized Controlled Study
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06356103
Sponsor's protocol ID: 0107060
Status last verified: Feb 2022
First submitted: 16 Mar 2024
Last updated: 19 Aug 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nutrition Disorder, Child trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Whey-Based Partially Hydrolyzed Formula Versus Polymeric Formula On Undernourished Neurologically Impaired Children: Open-labelled Randomized Study
ClinicalTrials.gov ID: NCT06356103
Acronym / sponsor ID: 0107060
Conditions: Nutrition Disorder, Child, Neurologic Disorder
Keywords: Neurological Impairment, Children, Partially Hydrolyzed Formula
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Alexandria UniversityUniversity, hospital or other
Study start: 1 Jun 2022 (actual)
Primary completion: 31 Dec 2022 (actual)
Study completion: 15 Jul 2023 (actual)
First posted: 10 Apr 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A Randomized Controlled Study

Arm	Type	Receives
Group I	Active comparator	Dietary Supplement: received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelinesreceived 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelines
Group II	Active comparator	Dietary Supplement: Whey-Based Partially Hydrolyzed Formulareceived 50% of their caloric requirements as WPHF and the other 50% as standard nutritional feeding

Who may qualify

Ages: 2 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

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:

Key exclusion criteria (1 listed)

NI due to metabolic diseases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Whey-Based Partially Hydrolyzed FormulaPeptamen junior, 100 kcal/100 ml (Nestlé Health Science, Vevey, Switzerland).	Dietary supplement	Group II
received 50% of their caloric requirements as isocaloric polymeric formula (standard ) and 50% standard nutritional feeding according to ESPGHAN guidelinesprotein and micronutrient requirements according to the recommended dietary allowance (RDA)	Dietary supplement	Group I

Primary outcome

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.
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).
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
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

4 secondary outcomes

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
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
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
Individual participant dataSharing planned: No

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Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
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RecruitingObservational study
Children s Growth and Behavior Study
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06356103.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.