A Randomised Controlled Trial of Thyroxine in Preterm Infants Under 28 weeks' Gestation. - TIPIT_Thyroxine In Preterm Infants Trial
Phase 1
- Conditions
- Hypothyroidism is a condition where there is a lack of thyroid hormone in the body. Thyroid hormones are important for normal brain development and growth. Children who are born with low thyroid hormones have severe learning difficulties if they are not treated early. The study protocol is based on recent evidence that very preterm babies are lacking in sufficient thyroid hormones and may benefit from thyroid hormone treatment at an early stage
- Registration Number
- EUCTR2005-003099-39-GB
- Lead Sponsor
- iverpool Women's NHS Foundation Trust Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
Inclusion Criteria
All infants with gestational age under 28 weeks at birth will be eligible for the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
oInfants born to mother with known thyroid disease or on antithyroid medications during pregnancy will be excluded.
oInfants born to mother who are on amiodarone during pregnancy will be excluded.
oInfants diagnosed with major congenital, intracranial or chromosomal abnormalities known to affect thyroid function or brain development will be excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method