Welcome
Support Centre
31 August 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation
ISRCTN ISRCTN89493983
DOI 10.1186/ISRCTN89493983
ClinicalTrials.gov identifier
EudraCT number 2005-003099-39
Public title A randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation
Scientific title
Acronym TIPIT (Thyroxine In Preterm Infants Trial)
Serial number at source MRC ref: G0501788; LWH0604
Study hypothesis 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
Lay summary Not provided at time of registration
Ethics approval Approved by the North West Multicentre Research Ethics Committee (ref: 07/MRE08/37)
Study design Randomised double-blinded placebo controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Premature infants
Participants - inclusion criteria All infants with gestational age under 28 weeks at birth
Participants - exclusion criteria 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
Anticipated start date 01/06/2007
Anticipated end date 01/12/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 150
Interventions 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/
Primary outcome measure(s) 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).
Secondary outcome measure(s) 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
Sources of funding 1. Medical Research Council (UK)
2. The Newborn Appeal (UK)
Trial website
Publications 1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18366798
2. 2008 MRI protocol in http://www.ncbi.nlm.nih.gov/pubmed/18590560
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23841945
Contact name Prof  Alan Michael  Weindling
  Address School of Reproductive and Developmental Medicine
University of Liverpool
First Floor
Liverpool Women’s Hospital
Crown Street
  City/town Liverpool
  Zip/Postcode L8 7SS
  Country United Kingdom
Sponsor Liverpool Women's NHS Foundation Trust (UK)
  Address Dr Gill Vernon
R&D Department Manager
Liverpool Women's Hospital
Crown Street
  City/town Liverpool
  Zip/Postcode L87SS
  Country United Kingdom
  Sponsor website: http://www.lwh.me.uk/
Date applied 20/03/2007
Last edited 15/07/2013
Date ISRCTN assigned 10/03/2008
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.