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Access to early intervention is crucial for affected children and families, particularly in resource-constrained settings with limited access to specialised services. This trial aims to evaluate the effectiveness and implementation of a bundle of\u00a0early identification,\u00a0care\u00a0and support, integrated into government health systems in Rwanda: the Pediatric Development Clinic (PDC)\/Baby Ubuntu programme.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study is a single-blind, effectiveness implementation-hybrid (type II) cluster randomised controlled trial with two arms (1:1 ratio). At cluster level, all community health centres in the three trial districts will be eligible for inclusion. At the participant level, at risk children aged\u2009\u2264\u200959\u00a0months will be eligible where \u2018at risk\u2019 is defined as being a survivor of a newborn condition that is a recognised risk factor for developmental disability (neonatal encephalopathy, prematurity, meningitis, severe jaundice, cerebral malaria, suspected genetic and chromosomal conditions and seizures), and\/or not meeting age-specific developmental milestones. Those receiving inpatient hospital treatment or in institutional care will not be eligible. Primary outcomes will be family health-related\u00a0quality of life (PedsQL) and child participation (Young Child Participation &amp; Environment Measure) assessed 12\u00a0months after enrolment and randomisation. Secondary outcomes include caregiver knowledge and confidence (scored structured assessments), psychological distress (Self-Report Questionnaire), experience of disability-affiliated stigma (Affiliate Stigma Scale), and\u00a0economic activity (time-use survey), in addition to\u00a0child mortality, illness and hospitalisation, child development\/function (Global Scales of Early Development, Malawi Developmental Assessment Tool, PEDI-CAT), and\u00a0nutritional status (weight-for-age, height-for-age). Analysis will be by intention-to-treat, consisting of all randomised subjects analysed according to assigned study arm. Cluster-level analyses will assess intervention effect.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Discussion<\/jats:title>\n                    <jats:p>The trial utilises best practice methodology and frameworks to conduct rigorous and comprehensive impact, process and economic evaluation of the intervention implemented and is\u00a0guided by a multi-disciplinary team and steering committee.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ISRCTN, ISRCTN17523514. Retrospectively registered 24 July 2024,\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/doi.org\/10.1186\/ISRCTN17523514\" ext-link-type=\"uri\">https:\/\/doi.org\/10.1186\/ISRCTN17523514<\/jats:ext-link>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-026-09613-7","type":"journal-article","created":{"date-parts":[[2026,3,20]],"date-time":"2026-03-20T07:16:24Z","timestamp":1773990984000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Early childhood intervention for children at risk of developmental disabilities and their caregivers in Rwanda: study protocol for the PDC\/Baby Ubuntu cluster randomised trial"],"prefix":"10.1186","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1846-8691","authenticated-orcid":false,"given":"Nathaniel","family":"Scherer","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathieu","family":"Nemerimana","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carol","family":"Nanyunja","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gatera Fiston","family":"Kitema","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samantha","family":"Sadoo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fabrice","family":"Iradukunda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mariella","family":"Munyuzangabo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Lassman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Rotenberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Bagahirwa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katie","family":"Greenland","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shanquan","family":"Chen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Carew","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Calum","family":"Davey","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giulia","family":"Greco","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lena Morgon","family":"Banks","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David John","family":"Musendo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francois","family":"Uwinkindi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hannah","family":"Kuper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily L.","family":"Webb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erick","family":"Baganizi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0131-4952","authenticated-orcid":false,"given":"Cally J.","family":"Tann","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,3,20]]},"reference":[{"key":"9613_CR1","volume-title":"Global report on children with developmental disabilities: from the margins to the mainstream","author":"World Health Organization, United Nations Children's Fund","year":"2023","unstructured":"World Health Organization, United Nations Children\u2019s Fund. 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BMJ. 2012;345:e5661.","journal-title":"BMJ"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-026-09613-7","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-026-09613-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-026-09613-7.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,27]],"date-time":"2026-03-27T09:01:50Z","timestamp":1774602110000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s13063-026-09613-7"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,20]]},"references-count":44,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["9613"],"URL":"https:\/\/doi.org\/10.1186\/s13063-026-09613-7","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,20]]},"assertion":[{"value":"17 October 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 March 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 March 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Ethical approval was granted by the Rwanda National Ethics Committee (RNEC213\/2023, No.28\/RNEC\/2024, RNEC672\/2024) and the London School of Hygiene & Tropical Medicine Research Ethics Committee (28527). As Trial sponsor, the London School of Hygiene & Tropical Medicine (2023-KEP-982) provides Clinical Trial\/Non-Negligent Harm Insurance and Medical Malpractice Insurance (F10816122) for participants in the study. We will obtain informed consent from all research participants. Informed consent will be taken by trained data collectors, all of whom will complete training in Good Clinical Practice and receive training on research ethics, informed consent and data collection procedures from experienced researchers in the Trial Management Group. Protocol amendments will be reported to the ethics committees and sponsor.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"240"}}