| Source of record | UK Trials |
| ISRCTN | ISRCTN89493983 |
| Date ISRCTN assigned | 10/03/2008 |
| Local reference number(s) | MRC ref: G0501788; LWH0604 |
| Public title | A randomised controlled trial of thyroxine in preterm infants under 28 weeks gestation |
| Scientific title |
|
| Acronym | TIPIT (Thyroxine In Preterm Infants Trial) |
| Disease/condition/study domain | Premature infants |
| 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. |
| Design/methodology | Randomised double-blinded placebo controlled trial |
| Research ethics review | Approved by the North West Multicentre Research Ethics Committee (ref: 07/MRE08/37) |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | All infants with gestational age under 28 weeks at birth |
| Participants - 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 |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/06/2007 |
| Anticipated end date | 01/12/2009 |
| Status of trial | Ongoing |
| Target number of participants | 150 |
| Interventions | 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. |
| 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).
|
| 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 |
| Sources of funding | 1. Medical Research Council (UK)
2. The Newborn Appeal (UK) |
| Sponsor name | Liverpool Women's NHS Foundation Trust and University of Liverpool (UK) |
| Sponsor details | Dr Gill Vernon
R&D Department Manager
Liverpool Women's Hospital
Crown Street
Liverpool
United Kingdom
L87SS |
| Contact name | Prof Alan Michael Weindling |
| Contact details | School of Reproductive and Developmental Medicine
University of Liverpool
First Floor
Liverpool Women¿s Hospital
Crown Street
Liverpool
United Kingdom
L8 7SS |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN89493983 |
| Date last extracted from ISRCTN register | 17/04/2008 |
