Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648863
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Bahir Dar Child Development Study Ethiopia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Bahir Dar Child Development Study Ethiopia
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCD
Brief Summary:
The goal of this observational study is to learn about typical neurodevelopment in children aged 6 months to 5 years who live in Bahir Dar Ethiopia The main aims of the study are
Aim 1 To characterize typical neurodevelopment as measured by i brain volume using low-field MRI and ii scores on behavioral assessments of early child neurodevelopment
Aim 2 To characterize typical pre-academic school skills in early childhood as measured by tasks of visual processing reasoning verbal expression and school readiness
Aim 3 To identify factors influencing child development in a community in Bahir Dar Amhara region of Ethiopia as measured by validated measures of maternal mental health home environment and childhood adversity
Participants will complete one low-field MRI scan at enrollment have a hemoglobin blood test and undergo age-appropriate neurodevelopmental assessments and surveys that may include
WHO Global Scales for Early Development GSED ages 6 - 36 months
Tasks of visual reasoning and verbal expression ages 48-60 months
Executive Functions test using the tablet-based NIH Toolbox ages 48-60 months
School Readiness questionnaire assessing knowledge of literacy numeracy early reading crystallized knowledge memory and self-regulation ages 48-60 months
Maternal report of childs motor cognitive and socioemotional skillsChild Anthropometrics assessment
Additional assessments of the participants family and environment will include
Medical History questionnaire
Family socioeconomic status
Maternal Mental Health
Recent Life Events and hardship
Home Environment and Parenting UNICEFs MICs Family Care Indicators
Food security and feeding practices
Aim 1 To characterize typical neurodevelopment as measured by i brain volume using low-field MRI and ii scores on behavioral assessments of early child neurodevelopment
Aim 2 To characterize typical pre-academic school skills in early childhood as measured by tasks of visual processing reasoning verbal expression and school readiness
Aim 3 To identify factors influencing child development in a community in Bahir Dar Amhara region of Ethiopia as measured by validated measures of maternal mental health home environment and childhood adversity
Participants will complete one low-field MRI scan at enrollment have a hemoglobin blood test and undergo age-appropriate neurodevelopmental assessments and surveys that may include
WHO Global Scales for Early Development GSED ages 6 - 36 months
Tasks of visual reasoning and verbal expression ages 48-60 months
Executive Functions test using the tablet-based NIH Toolbox ages 48-60 months
School Readiness questionnaire assessing knowledge of literacy numeracy early reading crystallized knowledge memory and self-regulation ages 48-60 months
Maternal report of childs motor cognitive and socioemotional skillsChild Anthropometrics assessment
Additional assessments of the participants family and environment will include
Medical History questionnaire
Family socioeconomic status
Maternal Mental Health
Recent Life Events and hardship
Home Environment and Parenting UNICEFs MICs Family Care Indicators
Food security and feeding practices
Detailed Description:
More than 170 million children worldwide under 5 years of age fail to meet their developmental potential Reduced or impaired neurodevelopment in early life can impact lifelong patterns of cognitive and behavioral development beginning with early and pre-academic skills that are vital to academic success achievement and predictive of later income health access and socioeconomic standing Improved early neurodevelopment on the other hand can spark an intergenerational cascade of improved family and child health outcomes
Infant and early childhood neurodevelopment can be impacted by a diverse array of environmental factors beginning from the earliest stages of fetal development Premature birth low birth weight poor maternal health maternal stress inadequate maternal and infant nutrition reduced breastfeeding exposure to disease environmental neurotoxicants and environmental adversity can all shape developing brain systems and impact emerging brain cognitive and behavioral functions However there is a gap in our understanding of neurodevelopmental patterns in children across LMIC settings where many neurodevelopmentally impactful adversities are magnified Increased knowledge of risk and protective factors associated with neurodevelopmental characteristics in children can support the identification of the global and regional factors that drive poor neurodevelopmental outcomes in children and help to inform interventions to improve child outcomes
The Bahir Dar Child Development BCD study will characterize patterns of neurodevelopment in a community sample of children in Bahir Dar Amhara Ethiopia using a cross-sectional design covering children aged 6 - 60 months Neuroimaging data collected using a low-field portable MRI scanner will be coupled with neurocognitive assessments and a broad assessment of child and family medical history nutritional status socioeconomic standing and other social determinants of health These data will be harmonized and integrated with similar data collected from other regions and countries to provide a global map of development and identify important targetable factors that will improve neurodevelopmental outcomes
Infant and early childhood neurodevelopment can be impacted by a diverse array of environmental factors beginning from the earliest stages of fetal development Premature birth low birth weight poor maternal health maternal stress inadequate maternal and infant nutrition reduced breastfeeding exposure to disease environmental neurotoxicants and environmental adversity can all shape developing brain systems and impact emerging brain cognitive and behavioral functions However there is a gap in our understanding of neurodevelopmental patterns in children across LMIC settings where many neurodevelopmentally impactful adversities are magnified Increased knowledge of risk and protective factors associated with neurodevelopmental characteristics in children can support the identification of the global and regional factors that drive poor neurodevelopmental outcomes in children and help to inform interventions to improve child outcomes
The Bahir Dar Child Development BCD study will characterize patterns of neurodevelopment in a community sample of children in Bahir Dar Amhara Ethiopia using a cross-sectional design covering children aged 6 - 60 months Neuroimaging data collected using a low-field portable MRI scanner will be coupled with neurocognitive assessments and a broad assessment of child and family medical history nutritional status socioeconomic standing and other social determinants of health These data will be harmonized and integrated with similar data collected from other regions and countries to provide a global map of development and identify important targetable factors that will improve neurodevelopmental outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None