{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T10:55:01Z","timestamp":1792061701257,"version":"4.4.0"},"reference-count":21,"publisher":"American Academy of Pediatrics (AAP)","issue":"3","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[1997,3,1]]},"abstract":"<jats:p>Objective.\u2003The Australian Collaborative Trial of Antenatal Thyrotropin-Releasing Hormone (ACTOBAT) assessed the efficacy of 200 \u03bcg of thyrotropin-releasing hormone (TRH) in combination with glucocorticoids in the prevention of neonatal lung disease.1 This paper reports the 12-month follow-up of the infants from the trial completed in 1994.<\/jats:p>\n               <jats:p>Design.\u2003This was a double-blinded randomized controlled trial.<\/jats:p>\n               <jats:p>Setting.\u2003Women were recruited from level 3 perinatal centers throughout Australia.<\/jats:p>\n               <jats:p>Participants.\u2003Mothers who had not withdrawn from treatment and whose infants were discharged alive (1262 infants). Extensive efforts were made to trace this entire cohort.<\/jats:p>\n               <jats:p>Outcome Measures.\u2003A questionnaire was mailed to parents for self-completion immediately before their baby's\/babies' first birthday. The questionnaire included a checklist to assess sensory, motor, language, and social development, and use of health services.<\/jats:p>\n               <jats:p>Results.\u2003 Milestone scores were developed from items on the follow-up form. Treatment with TRH was associated with an increased risk of motor delay, social delay, fine motor delay, sensory impairment, and early language impairment. No differences were seen between treatment and placebo groups for motor impairment.<\/jats:p>\n               <jats:p>Multivariate analyses were performed, adjusting for chronological age, duration of gestation at randomization, time from randomization to delivery, parity, history of perinatal death, history of preterm rupture of the membranes, infant sex, singleton or twin status, maternal age, and maternal blood pressure (systolic and diastolic) at randomization. For the total cohort (N = 1022), treatment with TRH was associated with motor delay (odds ratio [OR], 1.51; 95% confidence interval [CI] 1.11 to 2.05); social delay (OR 1.40; 95% CI 1.01 to 1.95); sensory impairment (OR, 2.00; 95% CI 1.06 to 3.74); severe impairment (OR, 1.75; 95% CI 1.07 to 2.87); and a trend toward motor impairment (OR, 1.50; 95% CI .97 to 2.33), early language impairment (OR, 1.27, 95% CI .90 to 1.79), and fine motor delay (OR, 1.15; 95% CI .83 to 1.60).<\/jats:p>\n               <jats:p>There were no differences between the treatment groups in hospital admissions (OR, 1.08; 95% CI .83 to 1.42), doctors' visits (general practitioner OR adj, 1.09; 95% CI .79 to 1.50 or specialist OR adj 1.15; 95% CI .87 to 1.49), respiratory symptoms (OR adj, 1.16; 95% CI .88 to 1.53), or behavioral disturbances (OR adj, .93; 95% CI .71 to 1.21).<\/jats:p>\n               <jats:p>Conclusions.\u2003Because antenatal administration of TRH is associated with small, consistent deficits in major milestone achievements at 12 months of age, it is essential that additional planned trials make provision for long-term follow-up. Antenatal TRH should only be used in the context of a clinical trial.<\/jats:p>","DOI":"10.1542\/peds.99.3.311","type":"journal-article","created":{"date-parts":[[2004,8,13]],"date-time":"2004-08-13T23:40:17Z","timestamp":1092440417000},"page":"311-317","source":"Crossref","is-referenced-by-count":70,"title":["Australian Collaborative Trial of Antenatal Thyrotropin-Releasing Hormone: Adverse Effects at 12-Month Follow-up"],"prefix":"10.1542","volume":"99","author":[{"given":"Caroline Anne","family":"Crowther","sequence":"first","affiliation":[{"name":"From the Department of Obstetrics and Gynaecology, University of Adelaide, South Australia 5005, Australia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet Esther","family":"Hiller","sequence":"additional","affiliation":[{"name":"Department of Community Medicine, University of Adelaide, Adelaide, South Australia, 5005, Australia; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ross Roger","family":"Haslam","sequence":"additional","affiliation":[{"name":"Department of Perinatal Medicine, Women's and Children's Hospital, North Adelaide, South Australia, 5006, Australia."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey Samuel","family":"Robinson","sequence":"additional","affiliation":[{"name":"From the Department of Obstetrics and Gynaecology, University of Adelaide, South Australia 5005, Australia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the ACTOBAT Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"417","published-online":{"date-parts":[[1997,3,1]]},"reference":[{"key":"2021120819205629500_B1"},{"key":"2021120819205629500_B2"},{"key":"2021120819205629500_B3","first-page":"322","article-title":"Corticosteroids prior to preterm delivery. 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Neonatal hypothyroxinaemia and risk of cerebral palsy in term infants in a population based study.","volume":"10","author":"Kuroda","year":"1996","journal-title":"Paediatr Perinat Epidemiol."},{"key":"2021120819205629500_B21"}],"container-title":["Pediatrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/99\/3\/311\/998185\/pe039700311o.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/publications.aap.org\/pediatrics\/article-pdf\/99\/3\/311\/998185\/pe039700311o.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,12,8]],"date-time":"2021-12-08T20:14:55Z","timestamp":1638994495000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.aap.org\/pediatrics\/article\/99\/3\/311\/67421\/Australian-Collaborative-Trial-of-Antenatal"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[1997,3,1]]},"references-count":21,"journal-issue":{"issue":"3","published-online":{"date-parts":[[1997,3,1]]},"published-print":{"date-parts":[[1997,3,1]]}},"URL":"https:\/\/doi.org\/10.1542\/peds.99.3.311","relation":{},"ISSN":["1098-4275","0031-4005"],"issn-type":[{"value":"1098-4275","type":"electronic"},{"value":"0031-4005","type":"print"}],"subject":[],"published":{"date-parts":[[1997,3,1]]}}}