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Follow up from infancy into the one-five year age range is key, as it constitutes a critical gap between infant and early childhood studies. Availability of portable neuroimaging (functional near infrared spectroscopy (fNIRS) and electroencephalography (EEG)) has enabled access to rural settings increasing the diversity of our sampling and broadening developmental research to include previously underrepresented ethnic-racial and geographical groups in low- and middle- income countries (LMICs). The primary objective of the Brain Imaging for Global Health (BRIGHT) project was to establish brain function - using longitudinal data from mother - for-age reference curves infant dyads living in the UK and rural Gambia and investigate the association between context-associated moderators and developmental trajectories across the first two years of life in The Gambia. In total, 265 participating families were seen during pregnancy, at 7\u201314 days, 1-, 5-, 8-, 12-, 18- and 24-months post-partum. An additional visit is now underway at 3\u20135 years to assess pre-school outcomes. The majority of our Gambian cohort live in poverty, but while resource-poor in many factors they commonly experience a rich and beneficial family and caregiving context with multigenerational care and a close-knit supportive community. Understanding the impact of different factors at play in such an environment (\n                    <ns4:italic>i.e.<\/ns4:italic>\n                    , detrimental undernutrition\n                    <ns4:italic>versus<\/ns4:italic>\n                    beneficial multigenerational family support) will (i) improve the representativeness of models of general cognitive developmental pathways from birth, (ii) identify causal pathways of altered trajectories associated with early adversity at both individual and group level, and (iii) identify the context-associated moderators (\n                    <ns4:italic>i.e.<\/ns4:italic>\n                    social context) that protect development despite the presence of poverty-associated challenges. This will in turn contribute to the development of targeted interventions.\n                  <\/ns4:p>","DOI":"10.12688\/gatesopenres.14795.2","type":"journal-article","created":{"date-parts":[[2024,9,5]],"date-time":"2024-09-05T11:16:17Z","timestamp":1725534977000},"page":"126","update-policy":"https:\/\/doi.org\/10.12688\/gatesopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":14,"title":["The Brain Imaging for Global Health (BRIGHT) Project: Longitudinal cohort study 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Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/gatesopenresearch.org\/articles\/7-126\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/7-126\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/gatesopenresearch.org\/articles\/7-126\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,4]],"date-time":"2024-10-04T03:50:22Z","timestamp":1728013822000},"score":1,"resource":{"primary":{"URL":"https:\/\/gatesopenresearch.org\/articles\/7-126\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,5]]},"references-count":165,"URL":"https:\/\/doi.org\/10.12688\/gatesopenres.14795.2","relation":{"has-version":[{"id-type":"doi","id":"10.12688\/gatesopenres.14795.1","asserted-by":"subject"}],"has-review":[{"id-type":"doi","id":"10.21956\/gatesopenres.17325.r37930","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/gatesopenres.17325.r39043","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/gatesopenres.17325.r37930","asserted-by":"object"}]},"ISSN":["2572-4754"],"issn-type":[{"value":"2572-4754","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,5]]},"assertion":[{"value":"Indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/7-126\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/gatesopenres.17325.r37930, Prerna Aneja, University of East Anglia, Norwich, England, 04 Oct 2024, version 2, indexed","URL":"https:\/\/gatesopenresearch.org\/articles\/7-126\/v2#referee-response-37930","order":0,"name":"referee-response-37930","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/gatesopenres.16121.r35766, Rihui Li, University of Macau, Taipa, 27 Feb 2024, version 1, 1 approved, 1 approved with reservations","URL":"https:\/\/gatesopenresearch.org\/articles\/7-126\/v1#referee-response-35766","order":1,"name":"referee-response-35766","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Sarah Lloyd-Fox<\/b>; \n<i>Posted: 12 May 2024<\/i>; We thank you for your helpful and constructive comments. We have addressed all comments in our revision and believe this has strengthened the manuscript. Below we provide detailed responses to the individual points raised (your points in bold, ours in standard or italicised.&nbsp;  \n<b>This study protocol introduces the detailed design and implementation of the Brain Imaging for Global Health (BRIGHT) project, which primarily aims to study the longitudinal change of brain function, cognitive development, and growth within the rural Gambian population. The protocol also aims to find out the critical developmental moderators, mediators, and markers of risk and resilience by comparing the Gambian cohort with the UK cohort. I think this is an exciting project that makes use of a variety of brain imaging techniques and behavioral assessments to collect multi-dimensional data. I have several minor suggestions to be considered.<\/b>  \n<b>It may be beneficial to list the specifications of the EEG, fNIRS system as well as the eye-tracking device used in this project, such as channel number, sampling rate, and whether short channels are used. Such information could help to justify the reliability and feasibility of the protocol.<\/b>  \n<b>Response: <\/b>We agree that these details would help contextualise our protocol and findings further. As outlined below, we have added additional detail to the relevant sections: fNIRS: \n<i>This multi-domain battery was designed to interrogate whether global health risk factors impact on development to result in global\/cross-domain differences in brain activity or localized\/domain-specific differences or altered function. Data were collected using the NTS optical imaging system (Gowerlabs Ltd. London, Everdell <i>et al.<\/i>, 2005), which emits near-infrared light at the 780nm and 850nm wavelengths with a sampling rate of 10Hz. The total array consisted of 18 channels at 1 month, 34 channels at 5, 8, 12, 18 and 24 months. The same 34-channel layout was used in BRIGHT kids.&nbsp; Channel separation was kept constant at 20mm across age points. Co-registration information from age and head size matched MRIs was used to adjust the placement guidelines of the headgear to ensure the channels were aligned over the frontal and temporal regions at each age point.<\/i> EEG: \n<i>Due to the nature of the sounds (pure tones, bursts of white noise etc.), no adaptations had to be undertaken allowing for identical protocols at both project sites. Infants were presented with auditory stimuli for approximately 15 minutes while asleep (at 1 month) or awake (at 5 and 18 months): during the latter an experimenter quietly entertained the infant with bubbles or silent toys to maintain calm attention during the task. We used a low-density (8 electrodes) gel based Neurolectrics Enobio EEG system with passive electrodes with a sampling rate of 500Hz.<\/i> Eye tracking: \n<i>A series of pilot studies were then completed in both the UK and The Gambia to identify population- and age- appropriate word-picture stimulus pairs. Data were collected using a Tobii TX-300 (Tobii AB, Sweden) remote eye tracker, set to a sampling rate of 60Hz.<\/i>  2.&nbsp;\n<b>A few neuroimaging tasks (e.g., working memory, habituation) are used in this project, please provide more information about these tasks.<\/b>  \n<b>Response: <\/b>We agree that such detail would be helpful to others wishing to implement similar task protocols. To not overload the manuscript with detailed methodological descriptions for all components of this extensive protocol, we have opted to more clearly signpost prior work (both our own and other groups\u2019) to provide easily accessible links to the specific tasks used.  \n<i>EEG: <\/i>\n<i>(for a description of the EEG task and full protocol see <\/i>\n<i>Katus et al., 2020)<\/i> \n<i>fNIRS: The fNIRS paradigms implemented in the BRIGHT project assessed a range of cognitive functions and domains, namely social cognition <\/i>\n<i>(see Lloyd-Fox et al., 2017 for details of task)<\/i>\n<i>, habituation and novelty detection <\/i>\n<i>(see Lloyd\u2010Fox et al., 2019)<\/i>\n<i>, working memory (using an adapted version of the task described in Begus et al., (2016)), deferred imitation (see Katus et al., (2022) for task description) and functional connectivity (see Bulgarelli et al., (2024)).<\/i> \n<i>Eye-tracking: <\/i>\n<i>The tasks used assessed cognitive control (Wass et al., 2011), habituation (Katus et al., 2019), attentional disengagement using the Gap\/Overlap task (Holmboe et al., 2010), non-social contingency (Delligianni, 2011), preference for faces (Gliga et al., 2009), and spontaneous looking (de Urabain et al., 2017).<\/i>  3 .\n<b>Psychiatric disorders, such as Autism or anxiety disorder, may be potential factors affecting brain and cognitive development. I wonder whether the research team is capable of screening and excluding those participants.<\/b>  \n<b>Response: <\/b>We agree that the conditions highlighted by the reviewer might affect the responses measured in this project. Infants who had suspected developmental delay or disability were referred for medical review and, as outlined in our exclusion criteria, those diagnosed with a developmental disability were excluded from the study. However, because autism and anxiety are typically not diagnosed until later in childhood, and due to the lack of appropriate medical expertise and follow up care, we did not screen for these conditions. The following is included in the main text: \n<i>Infants with suspected developmental delay or disability were referred for medical review and, as per the exclusion criteria, infants\/ children who were diagnosed with developmental disabilities (e.g. Down\u2019s Syndrome and cerebral palsy) were excluded from the study. Previously collected data relating to these participants was removed from the dataset. Specific screening for further psychiatric disorders including autism and anxiety disorder was not completed as (i) these conditions are usually diagnosed later in childhood and (ii) appropriate necessary medical expertise and follow up care was not available. Further screening will be taken into consideration if the cohort is followed up in the future.<\/i> 4.&nbsp;\n<b>Since the Phase 1 of BRIGHT is completed 3-4 years ago (ran from 2015-2020), I recommend the authors add a section or\/and table to briefly describe relevant publications and main findings in order to highlight the value of the BRIGHT project.<\/b>  \n<b>Response: <\/b>We added this information in the Table below, to provide a more accessible summary of key findings obtained to date: \n<i>We have multiple publications that describe both the methods development and pilot testing that was conducted prior to the start of the project, as well as publications from the data collected in BRIGHT (please see Table 6 for list and summary of BRIGHT publications to date).<\/i>  Table 6 overview for your benefit in this review reply (is formatted properly in the resubmission file). Info given in the following order: \n<b>Citation<\/b> \n<b>Title<\/b> \n<b>Data examined<\/b> \n<b>Main findings<\/b>  Lloyd-Fox et al., 2019 Habituation and novelty detection fNIRS brain responses in 5- and 8-month-old infants: The Gambia and UK. fNIRS habituation and novelty detection at 5 and 8 months in The Gambia and the UK Differential profiles of habituation and novelty detection across the two cohorts.  Katus et al., 2019 Implementing neuroimaging and eye tracking methods to assess neurocognitive development of young infants in low- and middle-income countries NA fNIRS, EEG and eye tracking show robustness for use in a less well-controlled lab setting in The Gambia. We address common challenges related to implementing a multi-method protocol longitudinally.  Blasi et al., 2019 fNIRS for Tracking Brain Development in the Context of Global Health Projects NA Review of the use of fNIRS in the context of global health studies. We discuss the implementation of fNIRS studies in LMICs with a particular emphasis on the Brain Imaging for Global Health (BRIGHT) project, and we consider its potential in this emerging field.  Katus et al., 2020 ERP markers predict neurodevelopmental outcomes in young infants in rural Africa and the UK. EEG auditory oddball data at 1 and 5 months, MSEL data at 5 months in UK and Gambia UK and Gambian cohort both show immature novelty response at 1 month of age. A novelty response emerges at group level in UK, but not in the Gambian cohort. The emergence of a novelty response is associated with concurrently MSEL scores at 5 months of age.  Collins-Jones et al., 2021 Longitudinal infant fNIRS channel-space analyses are robust to variability parameters at the group-level: An image reconstruction investigation. fNIRS Social paradigm at 5, 8 and 12 months in The Gambia Traditionally, fNIRS analysis is done in the channel space, where data from equivalent channels across participants is combined, assuming that head size and source and detector positions are constant across participants. We conclude that channel -space analysis of longitudinal fNIRS data is robust to assumptions about head size and array position given the variability in these parameters in our dataset.  Katus et al., 2022 Neural Marker of Habituation at 5 Months of Age Associated with Deferred Imitation Performance at 12 Months: A Longitudinal Study in the UK and The Gambia. EEG auditory oddball data at 1 and 5 months, deferred imitation data at 8 and 12 months of age in UK and Gambia EEG habituation indices at 5 months of age were associated with imitation responses at 12 months of age in both cohorts. In the Gambian cohort, EEG novelty responses at 5 months were also associated with imitation responses as 12 months of age.  Katus et al., 2023 Longitudinal fNIRS and EEG metrics of habituation and novelty detection are correlated in 1-18-month-old infants. EEG auditory oddball data and fNIRS habituation and novelty detection data at 1, 5 and 18 months in Gambian cohort only. fNIRS and EEG responses were correlated for habituation at 1 and 5&nbsp;months of age and for novelty detection at&nbsp; 5 and 18&nbsp;months of age.  Milosavljevic et al., 2023 \n<b>Executive functioning skills and their environmental predictors among pre-school aged children in South Africa and The Gambia<\/b>. Executive Functioning (EF; working memory, inhibitory control, and cognitive flexibility) collected at 3-5 years in the Gambia, and a South African sample of the same age. Performance on these tasks was examined in relation to task norms, and family enrichment factors (enrichment activities, diversity of caregivers) and socioeconomic status (SES), and caregiver educational attainment. The Gambian and South African participants showed normative performance across EF tasks, with evidence of heightened performance on the measure of cognitive flexibility. However, there were no associations between EF performance and measures of caregiver enrichment, SES or caregiver education in either site except an association between enrichment activities and working memory in the Gambian sample.  McCann et al., 2023 Iron status in early infancy is associated with cognitive development up to pre-school age in rural Gambia. Iron status in early infancy and trajectories of cognitice development using MSEL and the Eye-Tracking Gap Overlap task. Iron status ( measured by soluble transferrin receptor -sTfR) at 5 months of age is associated with MSEL cognitive score at 5 months and trajectory of cognitive development from 5months to 5 years. sTfR at 5 months was also associated with an eye tracking measure of visual attention in cross sectional analysis, however this relationship was diminished by 5 years of age.  Katus*, Crespo-Llado* et al., 2024 It takes a village: caregiver diversity and language contingency in the UK and rural Gambia LENA data at 12, 18 and 24 months for UK and Gambia. In the Gambia, earlier LENA measures of turn taking were associated with subsequent child vocalisations. In the UK, there was a trend toward such associations. In the Gambian cohort, we explored the role of caregiving: variability in caregiver numbers from one day to the next was associated with less turn taking. Total number of caregivers showed an inverted u-shaped relationship with turn taking: a medium number of caregivers was associated with highest turn taking frequencies.  Macrae et al., (2024) Cognitive control in infancy: attentional predictors using a tablet-based measure  Tablet-based measure of cognitive skills, attentional disengagement (Gap-overlap task) and general cognitive skills (MSEL) at 5-24 months in the UK. Participants showed significant improvements (at 24 months compared to 18 months) in cognitive control. General cognitive skills (measured using the MSEL) were not significantly associated with cognitive control, while attentional disengagement at 8 and 18 months was a significant predictor.  Pilot phase of the BRIGHT Project (2013 \u2013 2014)  Milosavljevic et al., 2019 \n<b>Adaptation of the Mullen Scales of Early Learning for use among infants aged 5- to 24-months in rural Gambia.<\/b> Pilot data collected using the MSEL, and measures of physical growth (height-for-age [HAZ], weight-for-height [WHZ], Head Circumference [HCZ]), collected at 9-24 months in The Gambia. Primarily, we report on the method adapting the MSEL for use in the rural Gambian context. We also find that infants show normative MSEL performance early in infancy (at 5-9 months), however from 10-14 months, they show poorer performance compared to normed scores. Additionally, both HAZ and WHZ were significantly associated with MSEL performance.  Lloyd-Fox et al., (2017) \n<b>Cortical specialisation to social stimuli from the first days to the second year of life: A rural Gambian cohort.<\/b> Pilot fNIRS and anthropometric data collected in first wave of longitudinal and cross-sectional analyses of infants aged 1 \u2013 24 months.   Lloyd-Fox et al., (2014) \n<b>Functional Near Infrared Spectroscopy (fNIRS) to assess cognitive function in infants in rural Africa.<\/b> Pilot fNIRS data collected during first study in The Gambia \u2013 4-8 month olds watched videos of a auditory and visual social cognition paradigm; a task showing Gambian adults performing social movements (i.e. Peekaboo) or vocalisations vs non-social stimuli Distinct regions of the posterior superior temporal and inferior frontal cortex evidenced either visual-social activation or vocally selective activation (vocal &gt; non-vocal). The patterns replicated those observed within similar aged infants in previous studies in the UK. These are the first reported data on the measurement of localized functional brain activity in young infants in Africa  Begus et al., (2016) \n<b>Using fNIRS to study working memory in infants in rural Africa.<\/b> Pilot fNIRS data collected in cross-sectional analyses - 12-16 month olds watched videos of an \n<i>object permanence <\/i>paradigm; a task testing the ability to create and hold a mental schema of an object in mind, when it is no longer visually accessible Differential neural activity was seen when infants observed objects being hidden for 3 (posterior superior temporal activity) compared to 6 seconds (additional regions of inferior frontal and anterior superior temporal activity). This cortical activation could potentially reflect working memory and executive functioning.  Papademetriou et al, (2014) \n<b>Optical imaging for brain activation in Gambian infants.<\/b>  Optical topography of fNIRS data from Lloyd-Fox et al., 2014 A finite element model to model the propagation of light through tissue and create optical topography images of brain activation  Blasi et al., (2014) Test\u2013retest reliability of functional near infrared spectroscopy in infants  Test re-test reliability of fNIRS signals from longitudinal data collection at 4 \u2013 8 and 12 \u2013 16 months of age At the group level, good spatial overlap of significant responses and signal reliability was seen At participant level, spatial overlap was acceptable although results highlighted that signal reliability varied between participants.","URL":"https:\/\/gatesopenresearch.org\/articles\/7-126\/v2#referee-comment-3689","order":2,"name":"referee-comment-3689","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"The BRIGHT Study is funded by the Bill and Melinda Gates Foundation (OPP1127625 and core funding MC\u2010A760\u20105QX00 to the International Nutrition Group by the Medical Research Council UK and the UK Department for International Development (DfID) under the MRC\/DfID COncordant agreement. S.L.F is supported by a UKRI Future Leaders Fellowship (MR\/S018425\/1). S.E.M is supported by a Wellcome Trust Senior Research Fellowship (220225\/Z\/20\/Z). L.K. was further supported by an ESRC Postdoctoral Fellowship, grant number ES\/T008644\/1 and a BBSRC grant, G114265. B.M. is supported by an Economic and Social Research Council (ESRC) Secondary Data Analysis Initiative Grant G110102 (ES\/V016601\/1). C.B. was further supported by a Leverhulme Trust Early Career Fellowship (ECF-2021-174). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":3,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}