Changes in Nerve Electro Physiologic Properties in Children Before and After Correction of Malnutrition
Changes in the Nerve Electro Physiologic Properties Before and After Correction of Malnutrition in Under-5 Children
1 other identifier
interventional
128
1 country
1
Brief Summary
The goal of this clinical trail study is to measure neurophysiologic parameters to assess the effect of malnutrition on the peripheral nervous system and their response to treatment in three categories (SAM, severe wasting, and severe stunting) of childhood malnutrition. 83 under-5 children from three categories of undernourished groups- severe stunting (n=30), Severe acute malnourished (n=22), wasting (n=31), and 45 age-matched healthy children from urban/peri-urban areas were enrolled. SAm were provided with appropriate nutritional therapy/treatment that include supplementation of a high-calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation. Egg milk and micronutrient supplementation were for recovery from severe stunting. Wasted children were treated with suitable local nutritional management (NM), such as infant and young child feeding practices (IYCF), providing MNP and nutrition education. Wasted children with medical complications were treated with specialized therapeutic milk (F-75) and those without medical complications were treated with a suitable local Nutritional Management (NM) \& routine medicines to treat simple medical conditions at community nutrition center (CNC) with weekly follow up. At day 60 of intervention, children were again brought to icddr,b for a nerve conduction test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedFirst Submitted
Initial submission to the registry
May 22, 2023
CompletedFirst Posted
Study publicly available on registry
June 7, 2023
CompletedJune 7, 2023
May 1, 2023
1.2 years
May 22, 2023
June 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Compound muscle action potential (CMAP) amplitude
Motor nerve compound muscle action potential (CMAP) amplitude is measured from baseline to peak amplitude for all the stimulation sites and expressed in millivolts (mV)
60 days
Motor nerve conduction velocity
Motor nerve conduction velocity is measured by the distance between the distal and proximal stimulation sites, divided by the difference in latency, and expressed in meters per second (m/s)
60 Days
Motor nerve corrected distal latency
Motor nerve corrected distal latency is measured from the onset (or rise of the negative deflection) of the compound muscle action potential and expressed in milliseconds (ms)
60 Days
Sensory nerve action potential (SNAP) amplitude
Sensory nerve action potential (SNAP) amplitude is measured from baseline-to-peak amplitude at the distal stimulation site and expressed in microvolts (μV)
60 Days
Sensory nerve conduction velocity
Sensory nerve conduction velocity is measured by the distance between the distal and proximal stimulation sites, divided by the difference in latency, and expressed in meters per second (m/s)
60 Days
Sensory nerve corrected distal latency
Sensory nerve corrected distal latency is measured from the onset (or rise of the negative deflection) of the compound muscle action potential and expressed in milliseconds (ms).
60 Days
Secondary Outcomes (6)
Changes in weight
60 Days
Changes in height
60 Days
Changes in Mid Upper Arm Circumference (MUAC) for SAM
60 Days
Changes in weight-for-height Z score for SAM
60 Days
Changes in weight-for-height Z score for Wasted
60 Days
- +1 more secondary outcomes
Study Arms (1)
Malnourished children
EXPERIMENTAL* Severe Stunting (length/height-for-age Z-scores \<-3SD) * Severe Acute Malnutrition (weight-for-length/height Z-scores \<-3SD, and/or mid-upper-arm circumference \<11.5 cm, with or without nutritional edema) * Wasting (weight-for-length/height Z-scores\<-3SD)
Interventions
* Severe acute malnourished children were provided with appropriate nutritional therapy/treatment that include supplementation of a high-calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation. * Egg milk and micronutrient supplementation for recovery from severe stunting following standard guidelines for facility based management and recently conducted community based nutrition intervention studies. * Wasted children were treated with suitable local nutritional management (NM), such as infant and young child feeding practices (IYCF), providing MNP and nutrition education.
Eligibility Criteria
You may qualify if:
- Participants who will give informed written consent
- Children aged between 6 months to 5 years of age
- Children whose length/height-for-age \<-3 (Stunted), weight-for-length/height \<-2 (Wasted), and weight-for-length/height z scores \<-3 and/or mid upper arm circumference \<11.5 cm, with or without nutritional edema
- Children whose length/height-for-age, weight-for-length/height, and weight-for-length/height z score will be ≥1
You may not qualify if:
- Participants with congenital anomalies, twins and multiple pregnancies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Icddr,B
Dhaka, Bangladesh
Related Publications (1)
Naila NN, Hossain MS, Alam A, Das S, Karmakar G, Mahfuz M, Ahmed T, Islam B. Nutritional Intervention Improves Nerve Conduction in Malnourished Children Under 5 Years of Age. Acta Paediatr. 2025 Nov;114(11):2864-2873. doi: 10.1111/apa.70179. Epub 2025 Jun 18.
PMID: 40530465DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2023
First Posted
June 7, 2023
Study Start
May 1, 2021
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
June 7, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share