{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,6]],"date-time":"2025-12-06T04:30:34Z","timestamp":1764995434807,"version":"3.46.0"},"reference-count":31,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2022,9,22]],"date-time":"2022-09-22T00:00:00Z","timestamp":1663804800000},"content-version":"unspecified","delay-in-days":21,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009228","name":"Region \u00d6rebro l\u00e4n","doi-asserted-by":"publisher","award":["OLL-934822"],"award-info":[{"award-number":["OLL-934822"]}],"id":[{"id":"10.13039\/501100009228","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Lilla Barnets Fond","award":["YE1353"],"award-info":[{"award-number":["YE1353"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2022,9,15]]},"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Preterm infants are at risk of negative consequences from stress and pain at the same time as they often are in need of intensive care that includes painful interventions. One of the frequent painful procedures preterm infants undergo is eye examination screening to detect early signs of ROP (retinopathy of prematurity). These examinations are both stressful and painful, and despite a multitude of research studies, no conclusive pain-relieving treatment has been demonstrated. The main aim of this trial is to investigate the analgesic effect of clonidine during ROP eye examinations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The planned study is a multicentre randomised controlled trial with a crossover design. Infants will be recruited from two different neonatal intensive care units (NICUs) in Sweden. Infants born before gestation week 30 (and therefore eligible for ROP screening) and cared for in either of the NICUs will be eligible for inclusion in the study. The primary outcome will be Premature Infant Pain Profile\u2013Revised score within 30\u2009s after starting the examination. Secondary outcomes will be changes in the galvanic skin response parameters (area small peaks, area huge peaks, peaks per second and average rise time) within 30\u2009s after starting the eye examination, together with the number and evaluation of adverse events reported within 72 hours after the examination and the examining physician\u2019s assessment of how easy the infant was to examine.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Approval from the Swedish Ethical Review Authority and the Swedish Medical Products Agency has been obtained for the study. Parents of eligible infants will be getting both verbal and written information about the study including that participation is voluntary. Data will be collected and treated in accordance with the European general data protection regulations. The results will be reported on group level and published in a scientific journal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04902859\">NCT04902859<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                    <jats:p>EudraCT (2021-003005-21).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2022-064251","type":"journal-article","created":{"date-parts":[[2022,9,22]],"date-time":"2022-09-22T12:10:48Z","timestamp":1663848648000},"page":"e064251","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Clonidine as analgesia during retinopathy of prematurity screening in preterm infants (cloROP): protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"12","clinical-trial-number":[{"clinical-trial-number":"nct04902859","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04902859","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Martina","family":"Carlsen Misic","sequence":"first","affiliation":[{"name":"Department of Pediatrics, Faculty of Medicine and Health, \u00d6rebro University, \u00d6rebro, Sweden"},{"name":"Faculty of Medicine and Health, School of Health Sciences, \u00d6rebro University, \u00d6rebro, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5996-2584","authenticated-orcid":false,"given":"Mats","family":"Eriksson","sequence":"additional","affiliation":[{"name":"Faculty of Medicine and Health, School of Health Sciences, \u00d6rebro University, \u00d6rebro, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erik","family":"Normann","sequence":"additional","affiliation":[{"name":"University Hospital, Neonatal Intensive Care Unit, Uppsala, Sweden"},{"name":"Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miriam","family":"Pettersson","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Faculty of Medicine and Health, \u00d6rebro University, \u00d6rebro, Sweden"},{"name":"Faculty of Medicine and Health, School of Medical Sciences, \u00d6rebro University, \u00d6rebro, Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5955-1278","authenticated-orcid":false,"given":"Ylva","family":"Blomqvist","sequence":"additional","affiliation":[{"name":"University Hospital, Neonatal Intensive Care Unit, Uppsala, Sweden"},{"name":"Department of Women's and Children's 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