Condition category
Neonatal Diseases
Date applied
20/03/2007
Date assigned
10/03/2008
Last edited
15/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Alan Michael Weindling

ORCID ID

Contact details

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

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

http://www.lwh.me.uk/

Funders

Funder type

Government

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes