Clinical trial NCT06356103: Whey-Based Partially Hydrolyzed Formula Versus Polymeric Formula On Undernourished Neurologically Impaired Children: Open-labelled Randomized Study
Official title: Whey-Based Partially Hydrolyzed Formula Versus Polymeric Formula On Undernourished Neurologically Impaired Children: Open-labelled Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorder, Child
Neurologic Disorder
Keywords: Neurological Impairment
Children
Partially Hydrolyzed Formula
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled Study
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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

Primary outcomes:
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).
timeFrame: 6 months
measure: 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).
timeFrame: 6 months
measure: 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).
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Children Hospital
Study officials:
References: