{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T20:43:03Z","timestamp":1789591383018,"version":"build-2803163510"},"reference-count":0,"publisher":"Georg Thieme Verlag KG","issue":"07","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Amer J Perinatol"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:p>Objective\u2003The main purpose of this article is to determine parental consent rates in neonatal drug trials and describe trial characteristics associated with higher rates.<\/jats:p>\n                  <jats:p>Study Design\u2003We included neonatal drug trials published between 2009 and 2014 and compared parental consent rates among the following characteristics: phase type, gestational age, randomization type, drug administration route, drug dosing frequency, blood sampling, control type, length of study, funding source, and length of treatment. We compared characteristics using chi-square, Fisher's exact, one-way analysis of variance or Kruskal\u2013Wallis tests.<\/jats:p>\n                  <jats:p>Results\u2003We identified 52 trials: 38 trials (73%) reported data of parental consent. Median percentage (interquartile range) of parental consent was 79% (62, 89). Higher rates were observed in studies that used active comparators (87%) and shorter study lengths (81% for studies &lt;24 hours).<\/jats:p>\n                  <jats:p>Conclusion\u2003Parental consent rates for neonatal drug trials varied by study characteristics. Information on proportion of parents consented is valuable to assess generalizability of trial results and for preparing trial protocols.<\/jats:p>","DOI":"10.1055\/s-0038-1675157","type":"journal-article","created":{"date-parts":[[2018,10,31]],"date-time":"2018-10-31T19:55:30Z","timestamp":1541015730000},"page":"759-764","source":"Crossref","is-referenced-by-count":7,"title":["Trial Characteristics That Affect Parental Consent in Neonatal Drug Trials"],"prefix":"10.1055","volume":"36","author":[{"given":"I. Blaire","family":"Hanvey","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sofia","family":"Aliaga","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew M.","family":"Laughon","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Testoni","sequence":"additional","affiliation":[{"name":"Escola Paulista de Medicina\u2013Universidade Federal de S\u00e3o Paulo, Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P. Brian","family":"Smith","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Duke University Medical Center, Durham, North Carolina"},{"name":"Duke Clinical Research Institute, Durham, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Bauserman","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of North Carolina School of Medicine, Chapel Hill, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"194","published-online":{"date-parts":[[2018,10,31]]},"container-title":["American Journal of Perinatology"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/www.thieme-connect.de\/products\/ejournals\/pdf\/10.1055\/s-0038-1675157.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2019,5,26]],"date-time":"2019-05-26T18:31:31Z","timestamp":1558895491000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.thieme-connect.de\/DOI\/DOI?10.1055\/s-0038-1675157"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2018,10,31]]},"references-count":0,"journal-issue":{"issue":"07","published-online":{"date-parts":[[2019,5,26]]},"published-print":{"date-parts":[[2019,6]]}},"URL":"https:\/\/doi.org\/10.1055\/s-0038-1675157","relation":{},"ISSN":["0735-1631","1098-8785"],"issn-type":[{"value":"0735-1631","type":"print"},{"value":"1098-8785","type":"electronic"}],"subject":[],"published":{"date-parts":[[2018,10,31]]}}}