{"id":55,"date":"2026-08-27T13:14:44","date_gmt":"2026-08-27T13:14:44","guid":{"rendered":"https:\/\/test.rhino-health.org\/follow-up\/"},"modified":"2026-08-27T13:14:44","modified_gmt":"2026-08-27T13:14:44","slug":"follow-up","status":"publish","type":"page","link":"https:\/\/rhino-health.org\/?page_id=55","title":{"rendered":"Follow-up"},"content":{"rendered":"
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AZTEC follow-up<\/div>\n

What happened after the neonatal trial?<\/h1>\n

AZTEC-FU follows children beyond 36 weeks’ postmenstrual age to understand respiratory health, neurodevelopment, growth, mortality and longer-term safety after neonatal azithromycin or placebo.<\/p>\n

1-year respiratory outcomes<\/span>2-year neurodevelopment<\/span>Growth<\/span>Longer-term safety<\/span><\/div>\n
Read AZTEC-FU protocol \u2192<\/a>Download PDF<\/a><\/div>\n<\/div>\n
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Why follow-up matters<\/div>\n

Neonatal outcomes are only the beginning<\/h2>\n

The primary AZTEC endpoint was assessed at 36 weeks’ postmenstrual age, but preterm birth and chronic lung disease can influence health well beyond neonatal discharge. The follow-up protocol therefore compares children originally allocated to azithromycin or placebo through 2 years’ corrected age.<\/p>\n

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Respiratory health<\/h3>\n

The main 1-year respiratory outcome is parent-reported wheeze. Follow-up also records home oxygen, duration of oxygen supplementation, respiratory hospital admissions, respiratory medications and survival without wheeze.<\/p>\n<\/article>\n

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Neurodevelopment<\/h3>\n

At 2 years, the main neurodevelopmental outcome is survival without combined moderate\/severe neurodevelopmental disability, supported by PARCA-R and available clinical developmental data.<\/p>\n<\/article>\n

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Growth & safety<\/h3>\n

Weight, length\/height and head circumference are assessed alongside mortality and safety surveillance, including pyloric stenosis after early macrolide exposure.<\/p>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n

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A national follow-up study<\/div>\n

How outcomes are collected<\/h2>\n

The protocol combines parent-reported information with routinely collected clinical data so that respiratory, developmental and growth outcomes can be assessed as completely as possible.<\/p>\n

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Families and questionnaires<\/h3>\n

Parents or guardians are contacted at 1 and 2 years’ corrected age. Questionnaires capture respiratory symptoms, admissions, antibiotic and respiratory drug use, growth and developmental information; the 2-year assessment includes PARCA-R.<\/p>\n<\/article>\n

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Linked clinical data<\/h3>\n

Information can also be obtained, where consent permits, from hospital records, general practitioners, the National Neonatal Research Database and national health datasets.<\/p>\n<\/article>\n

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UK network<\/h3>\n

The follow-up protocol describes children recruited from 28 tertiary neonatal units and approximately 77 step-down units across the UK.<\/p>\n<\/article>\n

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Biological studies<\/h3>\n

Respiratory and stool samples collected during AZTEC support analyses of cytokines, proteomics, microbiome profiles, Ureaplasma<\/em> colonisation and antimicrobial resistance.<\/p>\n<\/article>\n<\/div>\n<\/div>\n<\/section>\n

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The intervention being followed<\/div>\n

Early azithromycin exposure, assessed beyond discharge<\/h2>\n

In the main AZTEC trial, infants born before 30 weeks’ gestation were treated within 72 hours of birth with intravenous azithromycin for 10 days – 20 mg\/kg for 3 days followed by 10 mg\/kg for 7 days – or matched placebo. AZTEC-FU was designed to determine whether any effects of that early intervention emerge, persist or raise safety concerns during the first 2 years of life.<\/p>\n

Published protocol:<\/strong> Kotecha SJ, Course CW, Jones KE, Watkins WJ, Berrington J, Gillespie D, Kotecha S. Trials<\/em>. 2022;23:796. DOI: 10.1186\/s13063-022-06730-x.<\/div>\n<\/div>\n<\/section>\n
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The wider research journey<\/div>\n

Connecting AZTEC with BALLOON and RHiNO<\/h2>\n

The wider preterm lung-health programme spans the neonatal period, infancy after discharge and childhood. AZTEC addresses intervention around birth; BALLOON focuses on respiratory health after discharge; RHiNO studies later lung function and prematurity-associated lung disease.<\/p>\n

\"Illustration<\/div>\n<\/div>\n<\/section>\n","protected":false},"excerpt":{"rendered":"

AZTEC follow-up What happened after the neonatal trial? AZTEC-FU follows children beyond 36 weeks’ postmenstrual age to understand respiratory health, neurodevelopment, growth, mortality and longer-term safety after neonatal azithromycin or placebo. 1-year respiratory outcomes2-year neurodevelopmentGrowthLonger-term safety Read AZTEC-FU protocol \u2192Download PDF Why follow-up matters Neonatal outcomes are only the beginning The primary AZTEC endpoint was […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-55","page","type-page","status-publish","hentry"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/pages\/55","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rhino-health.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=55"}],"version-history":[{"count":0,"href":"https:\/\/rhino-health.org\/index.php?rest_route=\/wp\/v2\/pages\/55\/revisions"}],"wp:attachment":[{"href":"https:\/\/rhino-health.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=55"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}