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
Conditions
Interventions
Trade Name: Levothyroid
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Levothyroxine sodium
CAS Number: 67809-22-7
Conce
Sponsors
Liverpool Women's NHS Foundation Trust Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: o Infants born to mother with known thyroid disease or on antithyroid medications during pregnancy will be excluded. o Infants born to mother who are on amiodarone during pregnancy will be excluded. o Infants diagnosed with major congenital, intracranial or chromosomal abnormalities known to affect thyroid function or brain development will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine how treatment with levothyroxine (LT-4) postnatally until 32 weeks corrected gestational age (CGA) modulates brain size and development, the hypothalamic-pituitary-adrenal axis (HPA) and somatic growth. It will be an explanatory double blinded randomised controlled trial; Secondary Objective: To conduct an explanatory trial to assess in extreme preterm infants: ? Effect of thyroid replacement therapy on brain size as assessed by the width of the sub-arachnoid space45 measured at 36 weeks CGA using cranial ultrasound and serial head circumference as an index of brain weight. ? Effect of thyroid replacement therapy on thyroid status and the hypothalamic-pituitary-adrenal axis ? Effect of thyroid replacement therapy on somatic growth as assessed by serial auxology (taking account of nutritional intake) ? Relationship of thyroid status and thyroid gland size ? The extent of white matter myelination and the volumes of key brain structures at term equivalent using brain MRI examinations to measure of volumes of the caudate nuclei, hippocampus and temporal lobes ; Primary end point(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 Outcomes a) Serial head circumference as an index of brain weight b) Longitudinal thyroid hormone concentrations between birth and expected date of delivery; c) Cortisol hormone status between birth and expected date of delivery d) Auxological data at day 5 (baseline), day 14, day 28 and at 36 weeks CGA e) Thyroid gland size measured by ultrasound imaging f) Mortality g)The volumes of key brain structures and the exten | — |
Countries
United Kingdom
Outcome results
None listed