Perdomo‐Ramírez 2016.
Methods | Study type: prospective single‐centre study Setting: Hospital La Misericordia, Bogota, Colombia Information was based on additional information provided by trial authors. |
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Participants | 40 children with newly diagnosed ALL (mean age at diagnosis 8.5 years (range 2 to 17 years); 21 boys and 19 girls) | |
Interventions | According to the Berlin‐Frankfurt‐Münster (BFM) protocol: prednisone, vincristine, daunorubicin, L‐asparaginase Type of glucocorticoid therapy: induction phase: prednisone 60 mg/m2 for 28 consecutive days with 9 days of tapering Cumulative prednisone dose: 1837.5 mg/m2 Duration of glucocorticoid therapy: 28 days Method of cessation of glucocorticoid therapy: Dose was tapered by 50% every 3 days, until complete withdrawal over 9 days. No control intervention |
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Outcomes | Specific HPA axis function test: basal cortisol and ACTH levels at baseline; low‐dose ACTH test (1 µg Synacthen) between 7 and 8 a.m. at time points after cessation of glucocorticoid therapy (see below). This information was based on additional information provided by trial authors. Moment of testing: Baseline adrenal function was assessed by basal cortisol and ACTH levels before induction therapy. The first low‐dose ACTH stimulation test was performed 3 days after cessation of prednisone. Children with adrenal insufficiency underwent repeated low‐dose ACTH testing 7, 14, and 30 days after cessation of glucocorticoid therapy until normalisation of adrenal function. Tests were performed during treatment for ALL. Cutoff limits defined by original studies: basal cortisol: 6 to 30 µg/dL, baseline ACTH: 4.4 to 22 pmol/L. Low‐dose ACTH test: normal response ≥ 18 µg/dL (≥ 500 nmol/L) |
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Notes | One child died during follow‐up. Length of follow‐up after glucocorticoid therapy: up to 30 days. Funding source: Premio de Investigación (Research award), Josefa Cualla de Barberi Declaration of interest among primary researchers: Researchers declared that they had no conflicts of interest. |