{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:12:50Z","timestamp":1772169170427,"version":"3.50.1"},"update-to":[{"DOI":"10.12688\/wellcomeopenres.19689.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T00:00:00Z","timestamp":1722816000000}}],"reference-count":68,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T00:00:00Z","timestamp":1722816000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010269","name":"Wellcome Trust","doi-asserted-by":"crossref","award":["217123"],"award-info":[{"award-number":["217123"]}],"id":[{"id":"10.13039\/100010269","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns3:p>Background Over 250 million children are not reaching their developmental potential globally. The impact of prenatal factors and their interplay with postnatal environmental factors on child neurodevelopment, is still unclear\u2014particularly in low- and middle-income settings. This study aims to understand the impact of pregnancy complications as well as environmental, psychosocial, and biological predictors on neurodevelopmental trajectories. Methods This is an observational cohort study of female and male children (\u22483,950) born to women (\u22484,200) with and without pregnancy complications (pregnancy-induced hypertension, foetal growth restriction, and premature birth) previously recruited into PREgnancy Care Integrating Translational Science, Everywhere study with detailed biological data collected in intrapartum and post-partum periods. Children will be assessed at six weeks to 6 months, 11-13 months, 23-25 months and 35-37 months in rural and semi-urban Gambia (Farafenni, Illiasa, and Ngayen Sanjal) and Kenya (Mariakani and Rabai). We will assess children's neurodevelopment using Prechtls General Movement Assessment, the Malawi Development Assessment Tool (primary outcome), Observation of Maternal-Child Interaction, the Neurodevelopmental Disorder Screening Tool, and the Epilepsy Screening tool. Children screening positive will be assessed with Cardiff cards (vision), Modified Checklist for Autism in Toddlers Revised, and Pediatric Quality of Life Inventory Family Impact. We will use multivariate logistic regression analysis to investigate the impact of pregnancy complications on neurodevelopment and conduct structural equation modelling using latent class growth to study trajectories and relationships between biological, environmental, and psychosocial factors on child development. Conclusions We aim to provide information regarding the neurodevelopment of infants and children born to women with and without pregnancy complications at multiple time points during the first three years of life in two low-resource African communities. A detailed evaluation of developmental trajectories and their predictors will provide information on the most strategic points of intervention to prevent and reduce the incidence of neurodevelopmental impairments.<\/ns3:p>","DOI":"10.12688\/wellcomeopenres.19689.2","type":"journal-article","created":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T12:11:56Z","timestamp":1722859916000},"page":"508","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["The PRECISE-DYAD Neurodevelopmental substudy protocol: neurodevelopmental risk in children of mothers with pregnancy complications"],"prefix":"10.12688","volume":"8","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1889-7552","authenticated-orcid":false,"given":"Dorcas 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Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-508\/v2\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-508\/v2\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-508\/v2\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,9]],"date-time":"2024-08-09T01:05:27Z","timestamp":1723165527000},"score":1,"resource":{"primary":{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-508\/v2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8,5]]},"references-count":68,"URL":"https:\/\/doi.org\/10.12688\/wellcomeopenres.19689.2","relation":{"has-version":[{"id-type":"doi","id":"10.12688\/wellcomeopenres.19689.1","asserted-by":"subject"}],"has-review":[{"id-type":"doi","id":"10.21956\/wellcomeopenres.25204.r92167","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.25204.r92167","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.25204.r92166","asserted-by":"object"}]},"ISSN":["2398-502X"],"issn-type":[{"value":"2398-502X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8,5]]},"assertion":[{"value":"Indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-508\/v2#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.25204.r92167, Kimford Meador, Stanford University School of Medicine, Palo Alto, CA,, 09 Aug 2024, version 2, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-508\/v2#referee-response-92167","order":0,"name":"referee-response-92167","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.21809.r80149, Matthew Bluett-Duncan, The University of Manchester, Manchester, England, 13 May 2024, version 1, 1 approved, 1 approved with reservations","URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-508\/v1#referee-response-80149","order":1,"name":"referee-response-80149","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"<b>Melissa Gladstone<\/b>; \n<i>Posted: 25 Jul 2024<\/i>; \n<b>Q1: The phrasing of the second sentence of the abstract &quot;the impact of prenatal factors then influenced by postnatal environmental factors...&quot; is not very clear.<\/b> \n<b>Maybe something along the lines of &quot;prenatal factors and their interaction with postnatal environmental factors...&quot; would be better.<\/b> \n<u>Response:<\/u>\n<b>&nbsp;<\/b>We acknowledge the reviewer\u2019s suggestion to enhance the clarity of this paragraph. We have now revised the sentence to read:\n<i> \u201cThe impact of prenatal factors and their interplay with postnatal environmental factors\u2026.\u201d<\/i>  \n<b>Q2: In the third paragraph of the background section the sentence &quot;lower cognitive scores, autism, and intellectual disability&quot; reads as if autism and ID were lower in children of mothers with PIH, which I assume isn't what is intended?<\/b> \n<u>Response:<\/u>&nbsp;We thank the reviewer for bringing this to our attention. We have addressed this concern by refining the sentence as follows:&nbsp; \u2026.\n<i>lower cognitive scores, as well as a higher incidence of autism spectrum disorders and intellectual disability<\/i>.  \n<b>Q3: In aims and objectives, the inclusion of Epilepsy as a condition to study seems to come out of the blue. While I agree it is an important disorder to include, it may be helpful to include some justification as to why it is included specifically<\/b>. \n<u>Response:<\/u>&nbsp;We thank the reviewer for his valuable feedback. In response to this concern, we have now incorporated additional information in the fourth paragraph of the background section highlighting the association between placental complications and neurological conditions such as epilepsy as indicated below: \n<i>Although pregnancy complications are linked to adverse neurodevelopmental and neurological outcomes, which may include cerebral palsy, global developmental delay, and epilepsy, however, children survive without significant impairment.<\/i>  \n<b>Q4: Although it is clarified later on, it was not immediately clear to me how Aim 2 is distinct from Aim 1. It may be helpful to clarify further at this point.<\/b> \n<u>Response:<\/u>&nbsp;We have addressed this concern by revising the aims and objectives sections as follows: \n<i>Specifically, we aim first to quantify the impact of pregnancy complications on the likelihood of having a moderate to severe neurodevelopmental disability, a visual impairment, and\/or epilepsy) at the age of 2-3 years. <\/i> \n<i>&nbsp;Secondly, we aim to understand the relationship between pregnancy complications and neurodevelopmental outcomes at each time point and longitudinally across multiple developmental domains, including gross and fine motor development, language development, and social-emotional development.<\/i>  \n<b>Q5: For the observed mother-child interaction the authors state that due to concerns regarding the validity of the data when using cameras to film the assessments they instead chose to rate the interactions in the moment<\/b>. \n<b>In my experience, rating these interactions takes quite a bit of time and requires re-watching the interactions multiple times as part of the process and so I am a little concerned about the quality of these ratings done during the assessment. It may be that this specific rating scale is more simple than the scales I have experience with and my concern is unfounded. However, I think it would be helpful to further clarify how the team have ensured that these ratings are valid and reliable beyond the statement that the assessors were &quot;well-trained&quot;.<\/b> \n<u>Response:<\/u>&nbsp;We thank the reviewer for the insightful comment. We agree that rating mother-child interaction can be time-consuming and may require scrutiny to ensure accuracy. In response to the reviewer\u2019s query, we incorporated measures to address these concerns. To ensure the quality and reliability of our ratings, we employed a thorough process involving double scoring for every 10\n<sup>th<\/sup> assessment. Specifically, a senior research officer and the assigned research officer jointly rated the mother-child interaction and compared their scores. Any discrepancies were carefully discussed to ensure high inter-rater reliability. We believe that this rigorous quality check process enhances the validity and reliability of our ratings. We have now included this information under the Observation of mother-child interaction as indicated below: &nbsp; \n<i>\u2026The OMCI tool is a simple rating scale that is measured at the time of assessment by a trained local culturally embedded observer. It measures maternal sensitivity, acceptance and responding, scaffolding, language stimulation, and mutual enjoyment, which are assessed during a short interaction\u2026\u2026.<\/i> \n<i>\u2026..To enhance the accuracy of the mother-child ratings, every 10<sup>th<\/sup> dyad assessment was jointly evaluated by a senior research officer and a research officer. They compared their scores and discussed any discrepancies to ensure high inter-rater reliability.<\/i>  \n<b>Q6: I was also a bit unclear as to whether the follow-up element of the study was already ongoing or not. I recognise that this is clarified at the very end of the protocol but it may be helpful to have a comment earlier on in the document stating this very briefly.<\/b> \n<u>Response:<\/u>&nbsp;We have now added this information under \u201cdata collection procedures\u201d as indicated below: These assessments are on-going and are administered at each visit as summarised in Figure 2.","URL":"https:\/\/wellcomeopenresearch.org\/articles\/8-508\/v2#referee-comment-5747","order":2,"name":"referee-comment-5747","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"PRECISE-DYAD is supported by Wellcome [217123, <a href=https:\/\/doi.org\/10.35802\/217123>https:\/\/doi.org\/10.35802\/217123<\/a>; a Collaborative Award in Science award]. 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"}]}}