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 Womens Hospital
Crown Street
Liverpool
L8 7SS
United Kingdom

Study information

Study design	Randomised double-blinded placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronym	TIPIT (Thyroxine In Preterm Infants Trial)
Study objectives	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
Ethics approval(s)	Approved by the North West Multicentre Research Ethics Committee (ref: 07/MRE08/37)
Health condition(s) or problem(s) studied	Premature infants
Intervention	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/
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Thyroxine
Primary outcome measure	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 measures	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
Overall study start date	01/06/2007
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	150
Key inclusion criteria	All infants with gestational age under 28 weeks at birth
Key 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
Date of first enrolment	01/06/2007
Date of final enrolment	01/12/2009

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	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