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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05891457
Enrollment
128
Registered
2023-06-07
Start date
2021-05-01
Completion date
2022-06-30
Last updated
2023-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Acute Malnutrition, Stunting, Wasting

Keywords

Malnutrition, Nerve Conduction

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.

Interventions

COMBINATION_PRODUCTNutritional 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.

Sponsors

Swedish International Development Cooperation Agency (SIDA)
CollaboratorOTHER_GOV
International Centre for Diarrhoeal Disease Research, Bangladesh
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to 60 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sensory nerve corrected distal latency60 DaysSensory 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).
Compound muscle action potential (CMAP) amplitude60 daysMotor 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 velocity60 DaysMotor 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 latency60 DaysMotor 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) amplitude60 DaysSensory 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 velocity60 DaysSensory 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)

Secondary

MeasureTime frameDescription
Changes in weight60 DaysChanges in weight measured in kg
Changes in height60 DaysChanges in height measured in cm
Changes in Mid Upper Arm Circumference (MUAC) for SAM60 DaysChanges in Mid Upper Arm Circumference (MUAC) measured in mm or cm
Changes in weight-for-height Z score for SAM60 DaysChanges in weight-for-height Z score measured in points
Changes in weight-for-height Z score for Wasted60 DaysChanges in weight-for-height Z score measured in points
Changes in height-for-age Z score for Stunted60 DaysChanges in height-for-age Z score measured in points

Countries

Bangladesh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026