At a glance
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Multidimensional Evaluation of the Early Emergence of Executive Function and Emotional Regulation in Young Children in Bangladesh Using Nutritional and Psychosocial Intervention: A Pilot Study
In Brief
A clinical study evaluating Chickpea based RUSF, E-RUSF, and 1 other intervention for Executive Function Disorder and 2 related conditions. Completed, enrolled 297 participants across 1 site.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
Locally produced ready to use supplementary food (RUSF), 50 g/packet contains 204 kcal energy). Two packets of RUSF provided for consumption at a rate of 50-100 kcal/kg/day till the child's weight for height returns to normal (WHZ \>-1SD) or for maximum 3 months.
Enhanced Ready to use therapeutic feeds (E-RUSF), 50-100 kcal/kg/d daily until for anthropometric recovery (WHZ \> - 1SD) is achieved or for maximum 3 months then E-SQLNS will be given till the end of 2 years follow-up.
Well-nourished children at 1 year of age (WLZ/WHZ score \>-1 SD). No nutritional or psychosocial intervention. Only follow-up.
3 year olds previously untreated MAM children (WHZ \<-2 and ≥-3 z-score, and/or MUAC \<12.5 and ≥11.5 cm) and free from any acute illness will be used as the outcome reference group.
Interventions
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.
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.
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.