Additional identifiers
EudraCT number
2005-003099-39
ClinicalTrials.gov number
Protocol/serial number
MRC ref: G0501788; LWH0604
Study information
Scientific title
Acronym
TIPIT (Thyroxine In Preterm Infants Trial)
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
Ethics approval
Approved by the North West Multicentre Research Ethics Committee (ref: 07/MRE08/37)
Study design
Randomised double-blinded placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Thyroxine
Primary outcome measures
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 trial start date
01/06/2007
Overall trial end date
01/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All infants with gestational age under 28 weeks at birth
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
150
Participant 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
Recruitment start date
01/06/2007
Recruitment end date
01/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Reproductive and Developmental Medicine
Liverpool
L8 7SS
United Kingdom
Sponsor information
Organisation
Liverpool Women's NHS Foundation Trust (UK)
Sponsor details
Dr Gill Vernon
R&D Department Manager
Liverpool Women's Hospital
Crown Street
Liverpool
L87SS
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Funder name
The Newborn Appeal (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
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
Publication citations
-
Protocol
Ng SM, Turner MA, Gamble C, Didi M, Victor S, Weindling AM, TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation., Trials, 2008, 9, 17, doi: 10.1186/1745-6215-9-17.
-
MRI protocol
Ng SM, Turner MA, Gamble C, Didi M, Victor S, Malamateniou C, Parkes LM, Tietze A, Gregory L, Sluming V, Abernethy L, Weindling AM, TIPIT: a randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation: magnetic resonance imaging and magnetic resonance angiography protocol., BMC Pediatr, 2008, 8, 26, doi: 10.1186/1471-2431-8-26.
-
Results
Ng SM, Turner MA, Gamble C, Didi M, Victor S, Manning D, Settle P, Gupta R, Newland P, Weindling AM, An explanatory randomised placebo controlled trial of levothyroxine supplementation for babies born <28 weeks' gestation: results of the TIPIT trial., Trials, 2013, 14, 211, doi: 10.1186/1745-6215-14-211.