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TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation

Ng, Sze M.; Turner, Mark A.; Gamble, Carrol; Didi, Mohammed; Victor, Suresh and Weindling, Alan M. (2008) TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation. Trials, 9 . Article Number: 17. ISSN 1745-6215

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Abstract

Background Infants born at extreme prematurity (below 28 weeks' gestation) are at high risk of developmental disability. A major risk factor for disability is having a low level of thyroid hormone which is recognised to be a frequent phenomenon in these infants. At present it is unclear whether low levels of thyroid hormone are a cause of disability, or a consequence of concurrent adversity. Methods We propose an explanatory multi-centre double blind randomised controlled trial of thyroid hormone supplementation in babies born below 28 weeks' gestation. All infants will receive either levothyroxine or placebo until 32 weeks corrected gestational age. The primary outcome will be brain growth. This will be assessed by the width of the sub-arachnoid space measured using cranial ultrasound and head circumference at 36 weeks corrected gestational age. The secondary outcomes will be (a) thyroid hormone concentrations measured at increasing postnatal age, (b) status of the hypothalamic pituitary axis, (c) auxological data between birth and 36 weeks corrected gestational age, (d) thyroid gland volume, (e) volumes of brain structures (measured by magnetic resonance imaging), (f) determination of the extent of myelination and white matter integrity (measured by diffusion weighted MRI) and brain vessel morphology (measured by magnetic resonance angiography) at expected date of delivery and (g) markers of morbidity including duration of mechanical ventilation and chronic lung disease. We will also examine how activity of the hypothalamic-pituitary-adrenal axis modulates the effects of thyroid supplementation. This will contribute to decisions about which confounding variables to assess in large-scale studies.

Item Type:Article
Additional Information:Published: 26 March 2008. 13 pages (page numbers not for citation purposes).
Uncontrolled Keywords:PLASMA TRIIODOTHYRONINE CONCENTRATIONS; MAGNETIC-RESONANCE SPECTROSCOPY; CHILDREN BORN PRETERM; BIRTH-WEIGHT INFANTS; CONGENITAL HYPOTHYROIDISM; TRANSIENT HYPOTHYROXINEMIA; THYROID-FUNCTION; DEVELOPMENTAL-DISABILITY; NEUROLOGIC DEVELOPMENT; PREMATURE-INFANTS
Subjects:R Medicine > R Medicine (General)
R Medicine > RJ Pediatrics > RJ101 Child Health. Child health services
Departments, Research Centres and Related Units:Academic Faculties, Institutes and Research Centres > Faculty of Medicine > School of Reproductive & Developmental Medicine
Academic Faculties, Institutes and Research Centres > Research Centres > Medical Statistics and Health Evaluation, Centre for
DOI:10.1186/1745-6215-9-17
Publisher's Statement:© 2008 Ng et al., licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Related URLs:
Refereed:Yes
Status:Published
ID Code:652
Deposited On:25 Jun 2008 13:26
Last Modified:05 Mar 2012 15:40

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