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Recruiting NCT05629624

Evaluation of Executive Function and Emotional Regulation in Children in Bangladesh

Conditions: Executive Function Disorder, Emotional Regulation, Malnutrition, Child

Sex: All
Ages: 12 Months – 39 Months
Healthy volunteers: 1
Phase: NA
Enrollment: 280
Sponsor: Boston Children's Hospital

Location: 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.

Eligibility Criteria

Inclusion criteria:Inclusion criteria for malnourished (MAM) children at 1 and 3 years of age: All of the following criteria must be met for a subject to be eligible to participate in the studyMother willing to sign consent formChild age 12-15 months or 36-39 months of ageWHZ <-2 and ≥-3 z-score, and/or MUAC <12.5 and ≥11.5 cm and free from any acute illnessMother agrees to feed their children a study diet at home.Mother willing to bring the child to the clinic for assessment (morbidity, nutrition history, adherence to treatment, anthropometry and advice to mother on parenting) and clinical examination.Mother will agree to provide her biological samplesMother willing to have a child undergo biological sample collection and neuropsychological assessment at baseline (1-year-old) and at ages 2 years and 3 years at the clinic.Family has no plan to move from the study area in the next three years.Inclusion criteria for Control group with normal health (normal Z score):Mother willing to sign consent formChild age 12-15 monthsWHZ score > -1 and free from any acute illnessMother willing to bring the child to the clinic for assessment (morbidity, nutrition history, adherence to treatment, anthropometry and advice to mother on parenting) and clinical examination.Mother will agree to provide her biological samples (see below).Mother willing to have a child undergo biological sample collection and neuropsychological assessment at baseline at 1 year old and again at 2 years and 3 years at the clinic.Family has no plan to move from the study area in the next two years.Exclusion Criteria:Exclusion criteria for malnourished (MAM) children: Meeting any of the following criteria will exclude a subject from study participationMother who is not willing to sign a consent form.Congenital anomaly.Mother who is not willing to feed the rehabilitation feed or the small quantity supplement to her child.Family will not stay 3 years in the study area.Exclusion criteria for Control group with normal health (normal Z score): Meeting any of the following criteria will exclude a subject from study participation -Mother who is not willing to sign a consent form.Child age >15 months or < 12m.Mother who is not willing to feed the rehabilitation feed or the small quantity supplement to her child.Family will not stay 3 years in the study area.Any congenital anomaly.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05629624). StuddyBuddy aggregates publicly available trial information.