{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,5]],"date-time":"2026-03-05T02:33:37Z","timestamp":1772678017039,"version":"3.50.1"},"reference-count":57,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2022,12,1]],"date-time":"2022-12-01T00:00:00Z","timestamp":1669852800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"crossref","award":["APP1144111"],"award-info":[{"award-number":["APP1144111"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["Translating Research into Practice fellowship"],"award-info":[{"award-number":["Translating Research into Practice fellowship"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100004752","name":"Victorian Government","doi-asserted-by":"crossref","award":["Operational Infrastructure Support Program-No. N\/A"],"award-info":[{"award-number":["Operational Infrastructure Support Program-No. N\/A"]}],"id":[{"id":"10.13039\/501100004752","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,10,27]]},"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Infections are a leading cause of neonatal mortality globally and can be transmitted from mother-to-child vertically or horizontally. Fiji has higher rates of serious neonatal infections and infant skin and soft tissue infections (SSTIs) than high-income countries. Research from the Gambia found that a single dose of oral azithromycin in labour decreased bacterial carriage and infections in mothers and infants, particularly infant skin infections. The Bulabula MaPei clinical trial evaluates the safety and efficacy of a single dose of azithromycin in labour in reducing the incidence of maternal and infant SSTIs and other infections and the impact on bacterial carriage. It will also describe the effect of azithromycin on antimicrobial (AMR) resistance, the maternal and infant microbiome, and infant dysbiosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>We are conducting a blinded, placebo-controlled randomised clinical trial administering 2\u2009g of oral azithromycin, or placebo, given to healthy, pregnant women (\u226518 years) in labour in Suva, Fiji. The primary outcome is the cumulative incidence of SSTIs in infants by 3\u2009months of age. Secondary outcomes include the incidence of other infant and maternal infections, and safety and tolerability of azithromycin in mother and infant. Following informed consent, 2110 pregnant women will be randomised in a 1:1 ratio, with all study staff and participants masked to group allocation. Mother\/infant pairs will be followed up for 12 months over six visits collecting clinical data on infections, antimicrobial use, safety and anthropometrics, in addition to nasopharyngeal, oropharyngeal, rectovaginal and vaginal swabs, maternal breastmilk and infant stool samples, in order to compare bacterial carriage, AMR rates and microbiome. Recruitment for Bulabula MaPei started in June 2019.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This trial was approved and is being conducted according to the protocol approved by The Royal Children\u2019s Hospital Human Research Ethics Committee, Australia, and the Fiji National Health Research and Ethics Review Committee. The findings of this study will be disseminated in peer-reviewed journals and presented at conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT03925480\">NCT03925480<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-061157","type":"journal-article","created":{"date-parts":[[2022,12,1]],"date-time":"2022-12-01T14:01:50Z","timestamp":1669903310000},"page":"e061157","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Prevention of young infant infections using oral azithromycin in labour in Fiji (Bulabula MaPei): study protocol of a randomised control trial"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct03925480","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8625-2513","authenticated-orcid":false,"given":"Maeve","family":"Hume-Nixon","sequence":"first","affiliation":[{"name":"Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Asia-Pacific Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tupou","family":"Ratu","sequence":"additional","affiliation":[{"name":"Asia-Pacific Health, Murdoch Children's Research Institute, Suva, Fiji"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie","family":"Clark","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Colonial War Memorial Hospital, Suva, Fiji"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0599-8645","authenticated-orcid":false,"given":"Cattram Duong","family":"Nguyen","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Asia-Pacific Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eleanor F G","family":"Neal","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Asia-Pacific Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Casey L","family":"Pell","sequence":"additional","affiliation":[{"name":"Translational Microbiology, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathryn","family":"Bright","sequence":"additional","affiliation":[{"name":"Asia-Pacific Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emma","family":"Watts","sequence":"additional","affiliation":[{"name":"Asia-Pacific Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John","family":"Hart","sequence":"additional","affiliation":[{"name":"Asia-Pacific Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim","family":"Mulholland","sequence":"additional","affiliation":[{"name":"New Vaccines, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James","family":"Fong","sequence":"additional","affiliation":[{"name":"Ministry of Health and Medical Services, Suva, Fiji"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eric","family":"Rafai","sequence":"additional","affiliation":[{"name":"Ministry of Health and Medical Services, Suva, Fiji"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kelera","family":"Sakumeni","sequence":"additional","affiliation":[{"name":"Ministry of Health and Medical Services, Suva, Fiji"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ilisapeci","family":"Tuibeqa","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Colonial War Memorial Hospital, Suva, Fiji"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catherine","family":"Satzke","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Translational Microbiology, Murdoch Children's Research Institute, Parkville, Victoria, Australia"},{"name":"Department of Microbiology and Immunology, The University of Melbourne, Melbourne, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew","family":"Steer","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Department of Paediatrics, Royal Children's Hospital, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Tropical Diseases Research Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3077-9639","authenticated-orcid":false,"given":"Fiona M","family":"Russell","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, The University of Melbourne, Melbourne, Victoria, Australia"},{"name":"Asia-Pacific Health, Murdoch Children's Research Institute, Parkville, Victoria, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2022,12,1]]},"reference":[{"key":"2025121219595800000_12.12.e061157.1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(16)31593-8"},{"key":"2025121219595800000_12.12.e061157.2","unstructured":"Levels & Trends in Child Mortality, UNICEF, World Health Organization . World bank group, 2020"},{"key":"2025121219595800000_12.12.e061157.3","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(14)60496-7"},{"key":"2025121219595800000_12.12.e061157.4","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-3156.2011.02750.x"},{"key":"2025121219595800000_12.12.e061157.5","first-page":"154","article-title":"Aetiology of community-acquired neonatal sepsis in low and middle income countries","volume":"1","author":"Waters","year":"2011","journal-title":"J Glob Health"},{"key":"2025121219595800000_12.12.e061157.6","first-page":"63","article-title":"Prevention of early-onset neonatal group B streptococcal disease","volume":"6","author":"Mari\u00f3","year":"2013","journal-title":"Rev Obstet Gynecol"},{"key":"2025121219595800000_12.12.e061157.7","doi-asserted-by":"publisher","DOI":"10.3109\/14767058.2014.934804"},{"key":"2025121219595800000_12.12.e061157.8","doi-asserted-by":"crossref","DOI":"10.1155\/2016\/9315757","article-title":"Chlamydia trachomatis infection in pregnancy: the global challenge of preventing adverse pregnancy and infant outcomes in sub-saharan Africa and Asia","volume":"2016","author":"Adachi","year":"2016","journal-title":"Biomed Res Int"},{"key":"2025121219595800000_12.12.e061157.9","doi-asserted-by":"publisher","DOI":"10.3109\/14767050903214574"},{"key":"2025121219595800000_12.12.e061157.10","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0b013e3181f2e85f"},{"key":"2025121219595800000_12.12.e061157.11","doi-asserted-by":"crossref","first-page":"214","DOI":"10.1034\/j.1600-0412.2002.810305.x","article-title":"The prognostic impact of a prolonged second stage of labor on maternal and fetal outcome","volume":"81","author":"Janni","year":"2002","journal-title":"Acta Obstet Gynecol Scand"},{"key":"2025121219595800000_12.12.e061157.12","doi-asserted-by":"crossref","first-page":"10","DOI":"10.1016\/j.ijgo.2013.06.006","article-title":"Causes of puerperal and neonatal sepsis in resource-constrained settings and advocacy for an integrated community-based postnatal approach","volume":"123","author":"Miller","year":"2013","journal-title":"Int J Gynaecol Obstet"},{"key":"2025121219595800000_12.12.e061157.13","doi-asserted-by":"crossref","first-page":"e661","DOI":"10.1016\/S2214-109X(20)30109-1","article-title":"Frequency and management of maternal infection in health facilities in 52 countries (GLOSS): a 1-week inception cohort study","volume":"8","author":"","year":"2020","journal-title":"Lancet Glob Health"},{"key":"2025121219595800000_12.12.e061157.14","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(14)70227-X"},{"key":"2025121219595800000_12.12.e061157.15","article-title":"Antibiotic prophylaxis for episiotomy repair following vaginal birth","volume":"11","author":"Bonet","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"key":"2025121219595800000_12.12.e061157.16","doi-asserted-by":"crossref","first-page":"81","DOI":"10.2147\/IJWH.S98876","article-title":"Postcesarean wound infection: prevalence, impact, prevention, and management challenges","volume":"9","author":"Zuarez-Easton","year":"2017","journal-title":"Int J Womens Health"},{"key":"2025121219595800000_12.12.e061157.17","doi-asserted-by":"publisher","DOI":"10.1080\/08035250600640422"},{"key":"2025121219595800000_12.12.e061157.18","doi-asserted-by":"crossref","DOI":"10.1016\/j.eclinm.2021.101123","article-title":"A systematic review and meta-analysis of the effect of administration of azithromycin during pregnancy on perinatal and neonatal outcomes","volume":"40","author":"Hume-Nixon","year":"2021","journal-title":"EClinicalMedicine"},{"key":"2025121219595800000_12.12.e061157.19","doi-asserted-by":"crossref","DOI":"10.1542\/peds.2016-2281","article-title":"Azithromycin in labor lowers clinical infections in mothers and newborns: a double-blind trial","volume":"139","author":"Oluwalana","year":"2017","journal-title":"Pediatrics"},{"key":"2025121219595800000_12.12.e061157.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.cmi.2016.03.005"},{"key":"2025121219595800000_12.12.e061157.21","doi-asserted-by":"crossref","first-page":"1231","DOI":"10.1056\/NEJMoa1602044","article-title":"Adjunctive azithromycin prophylaxis for cesarean delivery","volume":"375","author":"Tita","year":"2016","journal-title":"N Engl J Med"},{"key":"2025121219595800000_12.12.e061157.22","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0000467"},{"key":"2025121219595800000_12.12.e061157.23","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(15)00132-2"},{"key":"2025121219595800000_12.12.e061157.24","doi-asserted-by":"crossref","first-page":"e1375","DOI":"10.1016\/S2214-109X(18)30383-8","article-title":"Effect of ten-valent pneumococcal conjugate vaccine introduction on pneumococcal carriage in Fiji: results from four annual cross-sectional carriage surveys","volume":"6","author":"Dunne","year":"2018","journal-title":"Lancet Glob Health"},{"key":"2025121219595800000_12.12.e061157.25","doi-asserted-by":"crossref","first-page":"210","DOI":"10.17843\/rpmesp.2020.372.4772","article-title":"Neonatal meningitis: a multicenter study in lima, peru","volume":"37","author":"Guill\u00e9n-Pinto","year":"2020","journal-title":"Rev Peru Med Exp Salud Publica"},{"key":"2025121219595800000_12.12.e061157.26","unstructured":"CWMH . Infection rates in infants admitted to colonial war Memorial Hospital (CWMH). Suva, Fiji, 2014-2015."},{"key":"2025121219595800000_12.12.e061157.27","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cix896"},{"key":"2025121219595800000_12.12.e061157.28","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciu514"},{"key":"2025121219595800000_12.12.e061157.29","doi-asserted-by":"publisher","DOI":"10.1097\/OLQ.0b013e318175d885"},{"key":"2025121219595800000_12.12.e061157.30","unstructured":"Fiji Islands . World Directory of Minorities and Indigenous Peoples: Minority rights group international; 2017."},{"key":"2025121219595800000_12.12.e061157.31","unstructured":"Birth rate, crude (per 1,000 people) - Fiji. World Bank Data: The World Bank, 2021"},{"key":"2025121219595800000_12.12.e061157.32","unstructured":"Colonial War Memorial Hospital Labour Ward . Labour ward monthly report annual 2019. Suva, Fiji; 2019."},{"key":"2025121219595800000_12.12.e061157.33","doi-asserted-by":"publisher","DOI":"10.1179\/146532806X120273"},{"key":"2025121219595800000_12.12.e061157.34","unstructured":"IMCI Chart Booklet . World Health organization, 2014"},{"key":"2025121219595800000_12.12.e061157.35","doi-asserted-by":"publisher","DOI":"10.1038\/ejcn.2016.135"},{"key":"2025121219595800000_12.12.e061157.36","doi-asserted-by":"publisher","DOI":"10.1542\/peds.2014-2026"},{"key":"2025121219595800000_12.12.e061157.37","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1002\/lary.26799","article-title":"Macrolide-associated sensorineural hearing loss: a systematic review","volume":"128","author":"Ikeda","year":"2018","journal-title":"Laryngoscope"},{"key":"2025121219595800000_12.12.e061157.38","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2013.08.062"},{"key":"2025121219595800000_12.12.e061157.39","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1500987"},{"key":"2025121219595800000_12.12.e061157.40","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pntd.0007635"},{"key":"2025121219595800000_12.12.e061157.41","doi-asserted-by":"publisher","DOI":"10.2471\/BLT.08.052712"},{"key":"2025121219595800000_12.12.e061157.42","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"2025121219595800000_12.12.e061157.43","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2019.103208"},{"key":"2025121219595800000_12.12.e061157.44","doi-asserted-by":"crossref","first-page":"3341","DOI":"10.1016\/j.vaccine.2010.02.087","article-title":"Hyporesponsiveness to re-challenge dose following pneumococcal polysaccharide vaccine at 12 months of age, a randomized controlled trial","volume":"28","author":"Russell","year":"2010","journal-title":"Vaccine"},{"key":"2025121219595800000_12.12.e061157.45","unstructured":"CWMH lab . Colonial War Memorial Hospital lab records; colonisation rates in Suva, Fiji. In: CWMH lab , ed. Suva, Fiji, 2014-2015."},{"key":"2025121219595800000_12.12.e061157.46","doi-asserted-by":"crossref","first-page":"D7","DOI":"10.1016\/j.vaccine.2013.01.009","article-title":"An overview of global GBS epidemiology","volume":"31 Suppl 4","author":"Le Doare","year":"2013","journal-title":"Vaccine"},{"key":"2025121219595800000_12.12.e061157.47","unstructured":"WHO . Newborns: improving survival and well-being; 2020."},{"key":"2025121219595800000_12.12.e061157.48","unstructured":"Neonatal mortality. UNICEF, 2020"},{"key":"2025121219595800000_12.12.e061157.49","doi-asserted-by":"crossref","DOI":"10.1186\/s40733-017-0037-y","article-title":"Microbiome and asthma","volume":"4","author":"Sokolowska","year":"2018","journal-title":"Asthma Res Pract"},{"key":"2025121219595800000_12.12.e061157.50","doi-asserted-by":"publisher","DOI":"10.1155\/2018\/2037838"},{"key":"2025121219595800000_12.12.e061157.51","doi-asserted-by":"crossref","first-page":"1191","DOI":"10.1093\/cid\/ciy254","article-title":"Long-term impact of oral azithromycin taken by gambian women during labor on prevalence and antibiotic susceptibility of streptococcus pneumoniae and staphylococcus aureus in their infants: follow-up of a randomized clinical trial","volume":"67","author":"Bojang","year":"2018","journal-title":"Clin Infect Dis"},{"key":"2025121219595800000_12.12.e061157.52","doi-asserted-by":"crossref","first-page":"e14","DOI":"10.1016\/S1473-3099(18)30444-4","article-title":"Antimicrobial resistance following mass azithromycin distribution for trachoma: a systematic review","volume":"19","author":"O'Brien","year":"2019","journal-title":"Lancet Infect Dis"},{"key":"2025121219595800000_12.12.e061157.53","doi-asserted-by":"crossref","first-page":"354","DOI":"10.4168\/aair.2018.10.4.354","article-title":"Microbiome in the gut-skin axis in atopic dermatitis","volume":"10","author":"Lee","year":"2018","journal-title":"Allergy Asthma Immunol Res"},{"key":"2025121219595800000_12.12.e061157.54","doi-asserted-by":"publisher","DOI":"10.1016\/j.chom.2015.04.006"},{"key":"2025121219595800000_12.12.e061157.55","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2016.03.054"},{"key":"2025121219595800000_12.12.e061157.56","doi-asserted-by":"crossref","first-page":"1147","DOI":"10.1093\/cid\/cix141","article-title":"Gut microbial diversity in antibiotic-naive children after systemic antibiotic exposure: a randomized controlled trial","volume":"64","author":"Doan","year":"2017","journal-title":"Clin Infect Dis"},{"key":"2025121219595800000_12.12.e061157.57","unstructured":"Azithromycin-Prevention in labor use study (A-PLUS). ClinicalTrials.gov, 2019"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2022-061157","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T04:00:16Z","timestamp":1765598416000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2022-061157"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12]]},"references-count":57,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2022,12,1]]},"published-print":{"date-parts":[[2022,12]]}},"alternative-id":["10.1136\/bmjopen-2022-061157"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2022-061157","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12]]}}}