A randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation
ISRCTN | ISRCTN89493983 |
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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
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 |
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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 |
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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
L8 7SS
United Kingdom
Sponsor information
Liverpool Women's NHS Foundation Trust (UK)
Hospital/treatment centre
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/ |
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https://ror.org/04q5r0746 |
Funders
Funder type
Government
Medical Research Council (UK)
Government organisation / National government
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 | |
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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 | 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 |