Hypothyroxinemia
Conditions
Keywords
very low birth weight infant, hypothyroxinemia, outcomes
Brief summary
In order to determine the efficacy and safety of thyroxine replacement, a randomized clinical trial of thyroxine supplementation for VLBW infant with hypothyroxinemia during the first month of age is conducted.
Detailed description
A prospective randomized unmasked controlled trial is conducted. Newborn infants with birth weight less than 1500g are randomized into thyroxine treatment or un-treatment group.
Interventions
DRUGthyroxine
thyroxine at the dose of 5 μg/kg-wt /day
Sponsors
Tokyo Metropolitan Bokuto Hospital
Tokyo Women's Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 4 Weeks
Healthy volunteers
No
Inclusion criteria
* Birth weight: less than 1500g * Gestation: 22 weeks 0 day ≤ * Serum free thyroxine level lower than 0.8 ng/dl * Serum thyrotropin lower than 10 μU/ml * Age of between 2 and 4 weeks after birth * Informed consent
Exclusion criteria
* any known thyroid disease in mother
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psychomotor development at 1.5 years of age | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Psychomotor development at 3 years of age | 6 years |
| Somatic growth at 3 years of age | 6 years |
| Duration of hospital stay | 6 years |
| Frequency of morbidities during the stay in NICu | 6 years |
Countries
Japan
Outcome results
None listed