{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T15:37:10Z","timestamp":1792337830151,"version":"4.4.0"},"reference-count":26,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2017,9,7]],"date-time":"2017-09-07T00:00:00Z","timestamp":1504742400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Endocrinology"],"published-print":{"date-parts":[[2018,1]]},"abstract":"Summary<\/jats:title>\n \n Objectives<\/jats:title>\n \n There is no licensed, dose\u2010appropriate formulation of hydrocortisone for children with adrenal insufficiency (\n AI<\/jats:styled-content>\n ) and patients rely on compounded adult medication. The aim of this study was to evaluate the absorption, palatability and safety of Infacort\n \u00ae<\/jats:sup>\n , an immediate\u2010release, granule formulation of hydrocortisone with taste masking.\n <\/jats:p>\n <\/jats:sec>\n \n Study design<\/jats:title>\n Single site with satellites attended by a \u201cflying\u201d doctor from investigator site.<\/jats:p>\n \n Open\u2010label, single\u2010dose study in three consecutive child cohorts (n\u00a0=\u00a024) with\n AI<\/jats:styled-content>\n ; Cohort 1, children aged 2 to <6\u00a0years (n\u00a0=\u00a012); Cohort 2, infants aged 28\u00a0days to <2\u00a0years (n\u00a0=\u00a06); Cohort 3, neonates aged 1 to <28\u00a0days (n\u00a0=\u00a06).\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Fasted children were given a single dose of Infacort\n \u00ae<\/jats:sup>\n as dry granules administered directly from a capsule or spoon followed by a drink. The primary end\u2010point was the maximum serum cortisol concentration up to 240\u00a0minutes after Infacort\n \u00ae<\/jats:sup>\n administration. Secondary end\u2010points were palatability and adverse events (\n AE<\/jats:styled-content>\n s).\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n All children showed an increase in cortisol above baseline after Infacort\n \u00ae<\/jats:sup>\n (\n P\u00a0<\/jats:italic>\n <\u00a0.0001), with geometric mean\u00a0\u00b1\u00a0\n SD<\/jats:styled-content>\n cortisol concentration at 60\u00a0minutes of 575.8\u00a0\u00b1\u00a0299.5\u00a0nmol\u00a0L\n \u22121<\/jats:sup>\n . There was no failure in administration of Infacort\n \u00ae<\/jats:sup>\n , and 95.5% of parents\/carers preferred Infacort\n \u00ae<\/jats:sup>\n to their child's current medication. In 7 children who completed the palatability questionnaire, 80% of responses were very good or neutral, and 20% were adverse. No serious or severe treatment\u2010emergent\n AE<\/jats:styled-content>\n s were reported.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n Infacort\n \u00ae<\/jats:sup>\n is well tolerated, easy to administer to neonates, infants and children and shows good absorption, with cortisol levels at 60\u00a0minutes after administration similar to physiological cortisol levels in healthy children.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/cen.13447","type":"journal-article","created":{"date-parts":[[2017,8,17]],"date-time":"2017-08-17T04:12:47Z","timestamp":1502943167000},"page":"21-29","source":"Crossref","is-referenced-by-count":60,"title":["Absorption and tolerability of taste\u2010masked hydrocortisone granules in neonates, infants and children under 6 years of age with adrenal insufficiency"],"prefix":"10.1111","volume":"88","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3892-0577","authenticated-orcid":false,"given":"Uta","family":"Neumann","sequence":"first","affiliation":[{"name":"Charit\u00e9 Universit\u00e4tsmedizin Berlin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin J.","family":"Whitaker","sequence":"additional","affiliation":[{"name":"Diurnal Limited Cardiff UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susanna","family":"Wiegand","sequence":"additional","affiliation":[{"name":"Charit\u00e9 Universit\u00e4tsmedizin Berlin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heiko","family":"Krude","sequence":"additional","affiliation":[{"name":"Charit\u00e9 Universit\u00e4tsmedizin Berlin Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Porter","sequence":"additional","affiliation":[{"name":"Diurnal Limited Cardiff UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madhu","family":"Davies","sequence":"additional","affiliation":[{"name":"Diurnal Limited Cardiff UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dena","family":"Digweed","sequence":"additional","affiliation":[{"name":"Diurnal Limited Cardiff UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernard","family":"Voet","sequence":"additional","affiliation":[{"name":"Diurnal Limited Cardiff UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard J.","family":"Ross","sequence":"additional","affiliation":[{"name":"The University of Sheffield Sheffield UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Blankenstein","sequence":"additional","affiliation":[{"name":"Charit\u00e9 Universit\u00e4tsmedizin Berlin Berlin 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