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

NCT ID: NCT05891457

Last Updated: 2023-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2022-06-30

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.

Conditions

Stunting; Severe Acute Malnutrition; Wasting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Nutritional Intervention

Intervention Type: COMBINATION_PRODUCT

• 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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swedish International Development Cooperation Agency (SIDA)

OTHER_GOV

Sponsor Role: collaborator

International Centre for Diarrhoeal Disease Research, Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Icddr,B

Dhaka, , Bangladesh

Countries

Bangladesh

References

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 Jun 18. doi: 10.1111/apa.70179. Online ahead of print.

Reference Type: DERIVED

PMID: 40530465 (View on PubMed)

Other Identifiers

PR-21013

Identifier Type: -

Identifier Source: org_study_id