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

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.

Study Overview

• Status: Completed
• Conditions: Wasting; Stunting; Severe Acute Malnutrition
• Intervention / Treatment: Combination product: Nutritional Intervention

Detailed Description

The purpose of this study is to measure neurophysiologic parameters to assess the effect of malnutrition on peripheral nervous system and their response to treatment in three categories (SAM, severe wasting and severe stunting) of childhood malnutrition. The electrophysiological properties of peripheral nerves in malnourished under-5 children before and after correction of severe malnutrition were assed.

This is an exploratory study conducted in icddr,b, Dhaka, Bangladesh. 83 under-5 children from three categories of undernourished groups- severe stunting (length-for-age Z-scores <-3), SAM (weight-for-length Z-scores <-3, and/or mid-upper-arm circumference <11.5 cm, with or without nutritional edema) and wasting (weight-for-length Z-scores (WLZ) <-2) were enrolled. A total of 45 age-matched healthy children selected as controls. Participants were identified from urban/peri-urban areas of Dhaka city. After enrolment, participants were brought to icddr,b Dhaka Hospital and data on socio-economic status, weaning practice, morbidity, and dietary intake were collected. Nerve electro physiologic parameters assessed by motor (median, ulnar, fibular and tibial) and sensory (median, ulnar and sural) nerve conduction studies (NCS) on enrollment.

SAM were treated with appropriate nutritional therapy/treatment that included supplementation of high calorie diet; i.e., F-100 milk and khichuri-halwa for nutritional rehabilitation. Egg-milk and micronutrient supplementation were provided for 2 months for recovery from severe stunting (following standard guidelines for facility based management and recently conducted community based nutrition intervention studies). As per national guidelines, children suffering from severe wasting with medical complications were treated with specialized therapeutic milks (F-75) and those without medical complications treated with a suitable local Nutritional Management (NM) & routine medicines to treat simple medical conditions at community nutrition center (CNC) with weekly follow up. Children were monitored in the community for 2 months. Monthly anthropometry had been done. On day 60 or 2 months of intervention, children with weight-for-length/height Z-scores ≥-1 and MUAC >115 mm were again brought to icddr, b for nerve conduction test.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Icddr,b

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Participants with congenital anomalies, twins and multiple pregnancies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Malnourished children; 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)

Combination product: Nutritional Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in weight	Changes in weight measured in kg	60 Days
Changes in height	Changes in height measured in cm	60 Days
Changes in Mid Upper Arm Circumference (MUAC) for SAM	Changes in Mid Upper Arm Circumference (MUAC) measured in mm or cm	60 Days
Changes in weight-for-height Z score for SAM	Changes in weight-for-height Z score measured in points	60 Days
Changes in weight-for-height Z score for Wasted	Changes in weight-for-height Z score measured in points	60 Days
Changes in height-for-age Z score for Stunted	Changes in height-for-age Z score measured in points	60 Days

Collaborators and Investigators

• Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
• Collaborators: Swedish International Development Cooperation Agency (SIDA)

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 3, 2023
• First Posted (Actual): June 7, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Malnutrition; Nerve Conduction
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Severe Acute Malnutrition
• Other Study ID Numbers: PR-21013

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