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Changes in Nerve Electro Physiologic Properties in Children Before and After Correction of Malnutrition

Primary Purpose

Stunting, Severe Acute Malnutrition, Wasting

Status
Completed
Phase
Not Applicable
Locations
Bangladesh
Study Type
Interventional
Intervention
Nutritional Intervention
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stunting focused on measuring Malnutrition, Nerve Conduction

Eligibility Criteria

6 Months - 60 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Icddr,B

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Malnourished children

Arm Description

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)

Outcomes

Primary Outcome Measures

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)
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)
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)
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)
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)
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).

Secondary Outcome Measures

Changes in weight
Changes in weight measured in kg
Changes in height
Changes in height measured in cm
Changes in Mid Upper Arm Circumference (MUAC) for SAM
Changes in Mid Upper Arm Circumference (MUAC) measured in mm or cm
Changes in weight-for-height Z score for SAM
Changes in weight-for-height Z score measured in points
Changes in weight-for-height Z score for Wasted
Changes in weight-for-height Z score measured in points
Changes in height-for-age Z score for Stunted
Changes in height-for-age Z score measured in points

Full Information

First Posted
May 22, 2023
Last Updated
June 3, 2023
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
Swedish International Development Cooperation Agency (SIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05891457
Brief Title
Changes in Nerve Electro Physiologic Properties in Children Before and After Correction of Malnutrition
Official Title
Changes in the Nerve Electro Physiologic Properties Before and After Correction of Malnutrition in Under-5 Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
Collaborators
Swedish International Development Cooperation Agency (SIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stunting, Severe Acute Malnutrition, Wasting
Keywords
Malnutrition, Nerve Conduction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Malnourished children
Arm Type
Experimental
Arm Description
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)
Intervention Type
Combination Product
Intervention Name(s)
Nutritional Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compound muscle action potential (CMAP) amplitude
Description
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)
Time Frame
60 days
Title
Motor nerve conduction velocity
Description
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)
Time Frame
60 Days
Title
Motor nerve corrected distal latency
Description
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)
Time Frame
60 Days
Title
Sensory nerve action potential (SNAP) amplitude
Description
Sensory nerve action potential (SNAP) amplitude is measured from baseline-to-peak amplitude at the distal stimulation site and expressed in microvolts (μV)
Time Frame
60 Days
Title
Sensory nerve conduction velocity
Description
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)
Time Frame
60 Days
Title
Sensory nerve corrected distal latency
Description
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).
Time Frame
60 Days
Secondary Outcome Measure Information:
Title
Changes in weight
Description
Changes in weight measured in kg
Time Frame
60 Days
Title
Changes in height
Description
Changes in height measured in cm
Time Frame
60 Days
Title
Changes in Mid Upper Arm Circumference (MUAC) for SAM
Description
Changes in Mid Upper Arm Circumference (MUAC) measured in mm or cm
Time Frame
60 Days
Title
Changes in weight-for-height Z score for SAM
Description
Changes in weight-for-height Z score measured in points
Time Frame
60 Days
Title
Changes in weight-for-height Z score for Wasted
Description
Changes in weight-for-height Z score measured in points
Time Frame
60 Days
Title
Changes in height-for-age Z score for Stunted
Description
Changes in height-for-age Z score measured in points
Time Frame
60 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Icddr,B
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No

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Changes in Nerve Electro Physiologic Properties in Children Before and After Correction of Malnutrition

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