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. 2017 Nov 6;2017(11):CD008727. doi: 10.1002/14651858.CD008727.pub4

Kuperman 2012.

Methods Study type: randomised double‐blind comparative study
Setting: Instituto da Criança (Children’s Institute), São Paulo University Medical School Hospital, Brazil. This information was based on additional information provided by trial authors.
Participants 29 children (16 children who received prednisone: mean age at diagnosis 8.0 ± 4.4 years; 3 boys and 13 girls; 13 children who received dexamethasone: mean age at diagnosis 5.3 ± 3.6 years, 9 boys and 4 girls) with ALL. Control group for determining cutoff peak cortisol level: 16 children (mean age at HPA axis function test 8.1 ± 2.7 years; 7 boys and 9 girls) suspected of having any endocrinopathy other than adrenal insufficiency
Interventions Treatment according to the Brazilian Childhood Leukemia Protocol 99. Standard remission induction phase: vincristine, L‐asparaginase, daunorubicin, methotrexate (IT), cytarabine (IT), and dexamethasone (IT). This information was based on additional information provided by trial authors.
Type of glucocorticoid therapy: remission induction phase: Children were randomised to receive prednisone (40 mg/m2/d) or dexamethasone (6 mg/m2/d), both divided into 3 daily doses for 28 days, without tapering.
Cumulative dose of glucocorticoid therapy: prednisone 1120 mg/m2 or dexamethasone 168 mg/m2
Duration of glucocorticoid therapy: 28 days
Methods of cessation of glucocorticoid therapy: abrupt
Outcomes Specific HPA axis function test: low‐dose ACTH test between 8 and 9 a.m. (1.0 µg/m2 of cosyntropin, basal cortisol and after 30 minutes)
Moment of testing: intervention groups: before remission induction and subsequently every week after 28 days of glucocorticoid therapy, over a total period of 8 weeks
Cutoff limits were defined by the control group: basal cortisol: not defined. Low‐dose ACTH test: normal response ≥ 14.2 µg/dL (≥ 392 nmol/L) after 30 minutes (control group’s mean peak cortisol level minus 1.96 standard deviation)
This study addressed type of glucocorticoid and presence of infection/stress (defined as hospitalisation due to fever with or without neutropenia) as risk factors.
Notes 2 children were lost to follow‐up at final measurement. Moreover, not all children underwent the low‐dose ACTH test every week after remission induction. Information on individual testing schedules and on adrenal recovery per child was not provided.
 Length of follow‐up after glucocorticoid therapy: 8 weeks
Funding source: research grant from the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
Declaration of interest among primary researchers: Researchers declared that they had no conflicts of interest.