Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05891457
Status:
COMPLETED
Last Update Posted:
2023-06-07
First Post:
2023-05-22
Brief Title:
Changes in Nerve Electro Physiologic Properties in Children Before and After Correction of Malnutrition
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
Official Title:
Changes in the Nerve Electro Physiologic Properties Before and After Correction of Malnutrition in Under-5 Children
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n30 Severe acute malnourished n22 wasting n31 and 45 age-matched healthy children from urbanperi-urban areas were enrolled
SAm were provided with appropriate nutritional therapytreatment that include supplementation of a high-calorie diet ie 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 icddrb for a nerve conduction test
SAm were provided with appropriate nutritional therapytreatment that include supplementation of a high-calorie diet ie 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 icddrb 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 icddrb 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 andor mid-upper-arm circumference 115 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 urbanperi-urban areas of Dhaka city After enrolment participants were brought to icddrb 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 therapytreatment that included supplementation of high calorie diet ie 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-lengthheight Z-scores -1 and MUAC 115 mm were again brought to icddr b for nerve conduction test
This is an exploratory study conducted in icddrb 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 andor mid-upper-arm circumference 115 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 urbanperi-urban areas of Dhaka city After enrolment participants were brought to icddrb 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 therapytreatment that included supplementation of high calorie diet ie 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-lengthheight Z-scores -1 and MUAC 115 mm were again brought to icddr b for nerve conduction test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None