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Basal and Cosyntropin-Stimulated Plasma Cortisol Concentrations, as Measured by High-Performance Liquid Chromatography, in Children Aged 5 Months to Younger than 6 Years

First Department of Pediatrics (G.P.C.), Athens University Medical School, 115 27 Athens, Greece; and AstraZeneca LP (L.O., T.U., B.S., F.C., M.G.), Wilmington, Delaware 19850

Address all correspondence and requests for reprints to: George P. Chrousos, M.D., F.A.A.P., M.A.C.P., M.A.C.E., Professor and Chairman, First Department of Pediatrics, Athens University Medical School, Aghia Sophia Children’s Hospital, 115 27 Athens, Greece. E-mail: chrousge{at}med.uoa.gr.

Context: Topical corticosteroids are the recommended first-line treatment for all severities of persistent asthma and moderate to severe allergic rhinitis. Potential adrenal suppression resulting from corticosteroid administration necessitates monitoring of children participating in clinical studies. Measurement of pretreatment cortisol concentrations is necessary to assess effects on adrenal function.

Objective: Plasma cortisol concentrations are assay dependent; normal reference range values must be obtained for each assay. Our objective is to provide these values for children as determined by HPLC.

Design and Patients: Two multicenter, randomized, double-blind, placebo-controlled studies evaluating basal and cosyntropin-stimulated morning plasma cortisol concentrations for patients aged 5 to younger than 12 months with asthma and patients aged 2 to younger than 6 yr with allergic rhinitis using HPLC were conducted.

Main Outcome Measures: Main planned outcomes of these studies are reported elsewhere. This manuscript reports plasma cortisol concentration reference range values.

Results: In general, mean basal plasma cortisol concentrations (n = 177) (mean ± SD, nmol/liter) were similar among the 5 to younger than 9 months, 9 to younger than 12 months, 2 to younger than 3 yr, 3 to younger than 4 yr, 4 to younger than 5 yr, and 5 to younger than 6 yr age groups (218 ± 149, 281 ± 144, 257 ± 105, 231 ± 83, 298 ± 118, and 237 ± 65, respectively) and increased to comparable levels 60 min after cosyntropin stimulation (n = 178; 622 ± 176, 638 ± 176, 697 ± 99, 655 ± 103, 662 ± 113, and 610 ± 68, respectively). However, patients younger than 12 months had wider ranges of basal and stimulated values.

Conclusions: Basal and cosyntropin-stimulated morning plasma cortisol concentrations of children aged 5 to younger than 12 months and 2 to younger than 6 yr were consistently measurable, with the large majority similar among the age groups examined, and comparable with those reported elsewhere for adults.