| Methods |
Randomised controlled trial |
| Participants |
47 babies with congenital hypothyroidism detected by newborn screening |
| Interventions |
Participants were randomly assigned to 3 dosage arms of 37.5 mcg/day (group 1), 62.5 mcg/day for 3 days followed by 37.5 mcg/day (group 2) and 50 mcg/day (group 3) |
| Outcomes |
1) Time to normalisation of TSH during the first 12 weeks of CHT treatment |
| Study details |
Initial dose of 50mcg/day (12‐17mcg/kg/day) (group 3) normalised TSH by 2 weeks of treatment. Initial dose of 37.5mcg/day (9‐3‐12 mcg/kg/day) (group 1) normalised TSH by 12 weeks of treatment. Initial dose of 62.5mcg/day for 3 days followed by 37.5 mcg/day never achieved normal TSH concentrations |
| Publication details |
J Pediatr 2002; 141:786‐92 |
| Stated aim of study |
Quote "The first objective of our study was to determine the ideal replacement dose of L‐thyroxine in infants with CH as judged by the time course of rise in T4 and free T4 and fall in TSH, by using 3 treatment arms. A second objective was to compare the rise in T4 and free T4 and fall in TSH between mild and severe cases of CH within each treatment group. A third objective was to reexamine the “target” T4 and free T4 range in the first 2 weeks of therapy, with the use of the above regimens, as judged by the corresponding TSH concentrations". |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Described as randomised, but no details of method given |
| Allocation concealment? |
Unclear risk |
Not described |
| Blinding?
All outcomes |
Unclear risk |
Did not report blinding of investigators |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Described as no losses to follow‐up |
| Free of selective reporting? |
Unclear risk |
Unable to identify any selective reporting in the included trial as did not have any access to the original trial protocols |
| Free of other bias? |
Unclear risk |
Participants were selected from a restricted geographical area in proximity to the hospital on the basis of the screening program for identifying congenital hypothyroidism babies. This may present a potential risk of bias due to pre‐selection of participants. |
