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

ISRCTN ISRCTN89493983
DOI https://doi.org/10.1186/ISRCTN89493983
EudraCT/CTIS number 2005-003099-39
Secondary identifying numbers MRC ref: G0501788; LWH0604
Submission date
20/03/2007
Registration date
10/03/2008
Last edited
15/07/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Alan Michael Weindling
Scientific

School of Reproductive and Developmental Medicine
University of Liverpool
First Floor
Liverpool Women’s Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Study information

Study designRandomised double-blinded placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymTIPIT (Thyroxine In Preterm Infants Trial)
Study objectivesThyroxine 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
Ethics approval(s)Approved by the North West Multicentre Research Ethics Committee (ref: 07/MRE08/37)
Health condition(s) or problem(s) studiedPremature infants
InterventionIn 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/
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Thyroxine
Primary outcome measureThe 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 measures1. Width of the sub-arachnoid space measured using cranial ultrasound at 36 weeks Corrected Gestational Age (CGA)
2. Head circumference at 36 weeks CGA
Overall study start date01/06/2007
Completion date01/12/2009

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants150
Key inclusion criteriaAll infants with gestational age under 28 weeks at birth
Key exclusion criteria1. 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
Date of first enrolment01/06/2007
Date of final enrolment01/12/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

School of Reproductive and Developmental Medicine
Liverpool
L8 7SS
United Kingdom

Sponsor information

Liverpool Women's NHS Foundation Trust (UK)
Hospital/treatment centre

Dr Gill Vernon
R&D Department Manager
Liverpool Women's Hospital
Crown Street
Liverpool
L87SS
England
United Kingdom

Website http://www.lwh.me.uk/
ROR logo "ROR" https://ror.org/04q5r0746

Funders

Funder type

Government

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom
The Newborn Appeal (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 26/03/2008 Yes No
Protocol article MRI protocol 30/06/2008 Yes No
Results article results 11/07/2013 Yes No