Clinical trial NCT05891457: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stunting
Severe Acute Malnutrition
Wasting
Keywords: Malnutrition
Nerve Conduction
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
Collaborators: name: Swedish International Development Cooperation Agency (SIDA)
First posted: 2023-06-07
Enrollment: 128
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Compound muscle action potential (CMAP) amplitude
timeFrame: 60 days
measure: Motor nerve conduction velocity
timeFrame: 60 Days
measure: Motor nerve corrected distal latency
timeFrame: 60 Days
measure: Sensory nerve action potential (SNAP) amplitude
timeFrame: 60 Days
measure: Sensory nerve conduction velocity
timeFrame: 60 Days
measure: Sensory nerve corrected distal latency
timeFrame: 60 Days
Secondary outcomes:
measure: Changes in weight
timeFrame: 60 Days
measure: Changes in height
timeFrame: 60 Days
measure: Changes in Mid Upper Arm Circumference (MUAC) for SAM
timeFrame: 60 Days
measure: Changes in weight-for-height Z score for SAM
timeFrame: 60 Days
measure: Changes in weight-for-height Z score for Wasted
timeFrame: 60 Days
measure: Changes in height-for-age Z score for Stunted
timeFrame: 60 Days
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Icddr,B
Study officials:
References: