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

ISRCTN	ISRCTN89493983
DOI	https://doi.org/10.1186/ISRCTN89493983
Clinical Trials Information System (CTIS)	2005-003099-39
Protocol serial number	MRC ref: G0501788; LWH0604
Sponsor	Liverpool Women's NHS Foundation Trust (UK)
Funders	Medical Research Council (UK), The Newborn Appeal (UK)

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

Primary study design	Interventional
Study design	Randomised double-blinded placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Thyroxine
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).
Key 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
Completion date	01/12/2009

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

School of Reproductive and Developmental Medicine

Liverpool
L8 7SS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/07/2013		Yes	No
Protocol article	protocol	26/03/2008		Yes	No
Protocol article	MRI protocol	30/06/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes