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ISRCTN
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ISRCTN89493983
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ClinicalTrials.gov identifier
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Public title
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A randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation
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Scientific title
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Acronym
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TIPIT (Thyroxine In Preterm Infants Trial)
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Serial number at source
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MRC ref: G0501788; LWH0604
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Study hypothesis
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Thyroxine supplementation given to extreme preterm infants postnatally until 32 weeks postmenstrual age modulates brain development and size, the Hypothalamic-Pituitary-Adrenal axis (HPT) and somatic growth.
More details can be found at: http://www.mrc.ac.uk/ResearchPortfolio/Grant/Record.htm?GrantRef=G0501788&CaseId=6765
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Ethics approval
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Approved by the North West Multicentre Research Ethics Committee (ref: 07/MRE08/37)
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Study design
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Randomised double-blinded placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Premature infants
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Participants - inclusion criteria
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All infants with gestational age under 28 weeks at birth
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Participants - exclusion criteria
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1. Infants born to mother with known thyroid disease or on antithyroid medications during pregnancy
2. Infants born to mother who are on amiodarone during pregnancy
3. Infants diagnosed with major congenital or chromosomal abnormalities known to affect thyroid function or brain development
4. Maternal death during or within 5 days after childbirth
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Anticipated start date
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01/06/2007
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Anticipated end date
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01/12/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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150
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Interventions
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In the initial phase, infants will receive either intravenous thyroxine or placebo at 8 mcg/kg birth weight/day single daily dose. In the next phase, once enteral feeds are fully established, oral thyroxine or placebo will be given at 8 mcg/kg birth weight/day single daily dose until the baby reaches 32 weeks CGA.
Details of Joint Sponsor:
University of Liverpool
Liverpool
L69 3BX
United Kingdom
Tel: +44 (0)151 794 2000
http://www.liv.ac.uk/
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Primary outcome measure(s)
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The primary outcome will be the width of the sub-arachnoid space measured using cranial ultrasound and head circumference at 36 weeks Corrected Gestational Age (CGA).
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Secondary outcome measure(s)
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1. Width of the sub-arachnoid space measured using cranial ultrasound at 36 weeks Corrected Gestational Age (CGA)
2. Head circumference at 36 weeks CGA
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Sources of funding
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1. Medical Research Council (UK)
2. The Newborn Appeal (UK)
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Trial website
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Publications
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Contact name
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Prof
Alan Michael
Weindling
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Address
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School of Reproductive and Developmental Medicine
University of Liverpool
First Floor
Liverpool Women’s Hospital
Crown Street
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City/town
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Liverpool
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Zip/Postcode
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L8 7SS
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Country
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United Kingdom
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Sponsor
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Liverpool Women's NHS Foundation Trust (UK)
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Address
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Dr Gill Vernon
R&D Department Manager
Liverpool Women's Hospital
Crown Street
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City/town
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Liverpool
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Zip/Postcode
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L87SS
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Country
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United Kingdom
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Sponsor website:
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http://www.lwh.me.uk/
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Date applied
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20/03/2007
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Last edited
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04/11/2009
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Date ISRCTN assigned
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10/03/2008
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