Malnutrition, Child Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 280 |
Est. completion date | August 2024 |
Est. primary completion date | August 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Months to 39 Months |
Eligibility | 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 study - Mother willing to sign consent form - Child age 12-15 months or 36-39 months of age - WHZ <-2 and =-3 z-score, and/or MUAC <12.5 and =11.5 cm and free from any acute illness - Mother 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 samples - Mother 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 form - Child age 12-15 months - WHZ score > -1 and free from any acute illness - 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 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 participation - Mother 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. |
Country | Name | City | State |
---|---|---|---|
Bangladesh | International Centre for Diarrheal Disease Research | Dhaka |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | International Centre for Diarrhoeal Disease Research, Bangladesh, The University of The West Indies, University of Auckland, New Zealand, Wellcome Trust |
Bangladesh,
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* Note: There are 37 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in BAYLEY-4 scores from 1 year to 2 years of age | Bayley-4 Scales of Infant and Toddler Development is standardized developmental assessment tool for determining a child's developmental status at a given age (up to 42 months) BAYLEY-4 assess development in children of 1-42 months old in 5 domains: cognition, motor, language, socio-emotional, and adaptive behavior. | All enrolled children at 1 year ±1m(11m-13m) and 2 years ±1m(23m-25m) | |
Secondary | Change in functional Near Infrared spectroscopy (fNIRS) from 1 year to 2 years of age | Brain activity will be assessed using fNIRS, a method that measures changes in blood oxygen concentration as a consequence of neural activity in the brain. fNIRS can be used to measure brain activity that is related to an externally presented stimulus, or it can measure the connections between brain activity in different parts of the brain with no explicit external stimulus presentation. Measures of hemodynamics reported by fNIRS include relative concentration changes in oxy-hemoglobin, deoxy-hemoglobin and total hemoglobin. The fNIRS measurement is completely non-invasive and has been used in infant studies of brain activity for over 15 years. | All enrolled children at 1 year ±1m(11m-13m) and 2 years ±1m(23m-25m) | |
Secondary | Change in Electroencephalogram (EEG) power from 1 year to 2 years of age | The EEG will be used to investigate functional connectivity and power spectra across different scalp regions during both rest (baseline) and task activity. In addition, we will deploy a number of perceptual and cognitive tasks while recording the event-related potential (a subset of the EEG). . ERPs measure changes in electrical activity of the brain in response to stimulus presentation (auditory, visual, etc0. In addition, sophisticated signal processing/machine learning approaches can be applied to examine EEG frequency information (e.g., theta activity, phase amplitude coupling), which could serve as indices of local circuit connectivity. The EEG works by detecting small charges emitted by the brain during activity, amplifying the signals, and graphing signals in real time. | All enrolled children at 1 year ±1m(11m-13m) and 2 years ±1m(23m-25m) | |
Secondary | Change in LENA (Language Environment Analysis) from 1 year to 2 years of age | The LENA recorder and software measure the frequency of vocalization/verbalizations and conversational turns in children. Digital audio recordings are collected in a participant's home at baseline visit and annually afterwards. Thus, we will be able to see the influence of language input at different crucial points in early development. Recording data at multiple time points also gives us a measure of the consistency of the language environment. | Baseline at 1 year ±1m(11m-13m) for control and intervention and 3 years ±2m(34m-38m) for the outcome reference group, and during follow up of control and intervention group at 2 years ±1m(23m-25m) and 3 years ±2m(34m-38m) of age. | |
Secondary | Change in Parent-Child Interaction coded data from 1 year to 2 years of age | A 10-15 minute interaction between parent and child will be recorded. Parents will be asked to engage their child in play or conversations in the presence and absence of toys and books. The child will also play with the toys/books while the parent completes short surveys or watches a short video. The interaction will be filmed and transcribed. Language transcripts and videos will be coded for the child's and parent's use of language and mutual engagement. | All enrolled children at 1 year ±1m(11m-13m) and 2 years ±1m(23m-25m) | |
Secondary | Change in weight in kilograms at the start of intervention until they reach within 1 standard deviation of the mean | Weight will be measured at enrollment, then weekly during rehabilitation to achieve anthropometric recovery, and then quarterly for the duration of the study (till 36months of age) from 140 children who have enrolled with MAM. Weight data will also be collected from 70 normal children at enrolment, then monthly for 3 months, then quarterly for the duration of the study (until 36months of age). | Baseline, weekly, quarterly | |
Secondary | Change in height in meters at the start of intervention until they reach within 1 standard deviation of the mean | Height will be measured at enrollment, then weekly during rehabilitation to achieve anthropometric recovery, and then quarterly for the duration of the study (till 36months of age) from 140 children who have enrolled with MAM. Height data will also be collected from 70 normal children at enrolment, then monthly for 3 months, then quarterly for the duration of the study (until 36 months of age). | Baseline, weekly, quarterly | |
Secondary | Change in Mid-upper arm circumference (MUAC) in centimeters at the start of intervention until they reach within 1 standard deviation of the mean | MUAC will be measured at enrollment, then weekly during rehabilitation to achieve anthropometric recovery, and then quarterly for the duration of the study (till 36months of age) from 140 children who have enrolled with MAM. MUAC data will also be collected from 70 normal children at enrolment, then monthly for 3 months, then quarterly for the duration of the study (until 36months of age). | Baseline, weekly, quarterly | |
Secondary | Change in head circumference in centimeters | Head circumference will be measured at enrollment, at the age of 2 years and 3 years. | Baseline, 2 years, 3 years | |
Secondary | Change in blood analytes | 2-3 ml of child blood will be collected at enrollment, at the time of achieved ideal wt/ht (anthropometry recovery) or at the end of 3 months of E-RUSF/RUSF intervention, 24 months and 36 months of age to perform concentration of 24 vitamins and mineral micro nutrients, functional lipid concentrations in red cell membrane, serum siallylated milk oligo saccharides, Lutein/ zeaxantnine / cryptoxanthine and Microbiome directed blood metabolome. | Baseline, 3 months, 24 months, 36 months | |
Secondary | Change in stool metabolome | Stool sample will be collected at enrollment, at the time of achieved ideal wt/ht (anthropometry recovery), or at the end of 3 months of E-RUSF/RUSF intervention, 24 months and 36 months of age to perform 16S microbial sequencing, Functional pathway analysis and stool metabolome. | Baseline, 3 months, 24 months, 36 months |
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