Evaluation of Executive Function and Emotional Regulation in Children in Bangladesh

Summary

The study explores the impact of malnutrition at enrollment on executive function (EF) and emotional regulation (ER) in malnourished 1-year-old children and whether specially designed brain directed therapeutic feeds improve EF/ER outcomes at three years of age. The study will detect changes in EF and ER related to nutritional rehabilitation using specially designed ready to use therapeutic feeds (E-RUSF Nutriset) during the repletion phase and maintained for two years until age 3 with enhanced E-SQLNS (small quantity lipid based nutrient supplement) also modified to provide adequate brain directed micro and macronutrients. The investigators hypothesize that standard Bangladeshi designed B-RUSF and SQLNS (Nutriset) do not provide adequate nutrients to supply the brain during the rapid catch-up growth and subsequent early childhood growth phases of rehabilitation from Moderate Acute Malnutrition (MAM). The investigators predict that the children with moderately severe malnutrition treated with E-RUSF followed by 2 years of E-SQLNS will show an exuberance of connections (higher functional connectivity) than children receiving standard Bangladeshi rehabilitation feeds B-RUSF and SQLNS. This prediction is based on past work using EEG to examine the BEAN sample in Bangladesh, and differs from the sample in Boston, where the investigators anticipate that among healthy, normally nourished children, greater connectivity will be associated with better cognitive outcomes. The Core Toolkit will be deployed to the Bangladesh site to define its utility in prediction of executive dysfunction and emotional dysregulation in the context of low-income status, malnutrition and nutritional intervention. All nutritional intervention groups of malnourished children will also receive a set psychosocial stimulation curriculum that has been shown to be effective on severely malnourished children with therapeutic feedings.

Conditions

• Executive Function Disorder
• Emotional Regulation
• Malnutrition, Child

Interventions

DIETARY_SUPPLEMENT

Chickpea based RUSF

One group will receive locally produced RUSF, approximate at 50-100 kcal/kg/day, two of 50g packets daily (42) until anthropometric recovery ( WHZ \> - 1SD) has been achieved or for maximum 3 months then immediately 1 packet / day SQLNS will be given throughout the study till the end of 2 years of follow-up.

DIETARY_SUPPLEMENT

E-RUSF

The other group will receive the E-RUSF at 50-100 kcal/kg/day which in this age group approximates one 92 g sachet daily until anthropometric recovery ( WHZ \> - 1SD) has been achieved or for a of maximum 3 months, then immediately E-SQLNS 1 packet daily provided throughout the study till the end of 2 years of follow-up.

DIETARY_SUPPLEMENT

Outcome reference group/RUSF

We will also recruit 70 three-year-old previously untreated MAM children WHZ \<-2 and ≥-3 z-score, and/or MUAC \<12.5 and ≥11.5 cm as an outcome reference group for a singular assessment. All children (both case \& control) will undergo a baseline nutritional, medical, biological and neuropsychological assessment (EF, ER, EEG and fNIRS). After all the assessments chick-pea based RUSF will be given for 2 months for nutritional rehabilitation.

Sponsors & Collaborators

• The University of The West Indies

  collaborator OTHER

• International Centre for Diarrhoeal Disease Research, Bangladesh

  collaborator OTHER

• University of Auckland, New Zealand

  collaborator OTHER

• Wellcome Trust

  collaborator OTHER

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Charles Nelson, Ph.D · Children's Hospital Boston/Harvard University

• Terrence Forrester, Dr · University of the West Indies

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Months

Max Age

39 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-02-07

Primary Completion

2024-08-31

Completion

2024-08-31

Countries

• Bangladesh

Study Locations