A Randomized-Controlled Trial of Prophylactic Hydrocortisone Supplementation for the Prevention of Hypotension in Extremely Low Birth Weight Infants

• Published in: Journal of Perinatology Vol. 25; no. 2; pp. 119 - 124
• Main Authors: Efird, Meica M, Heerens, Ann T, Gordon, Phillip V, Bose, Carl L, Young, David A
• Format: Journal Article
• Language: English
• Published: United States Nature Publishing Group 01.02.2005
• Subjects: Adrenal Insufficiency - complications; Adrenal Insufficiency - drug therapy; Birth weight; Birth weight, Low; Cohort Studies; Complications and side effects; Dosage and administration; Double-Blind Method; Glucocorticoids; Hormone Replacement Therapy; Humans; Hydrocortisone; Hydrocortisone - therapeutic use; Hypotension; Hypotension - etiology; Hypotension - prevention & control; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases - etiology; Infant, Premature, Diseases - prevention & control; Infant, Very Low Birth Weight; Infants; Low birth weight; Neonates; Pathogenesis; Physiological aspects; Pilot Projects; Placebos; Prevention; Prophylaxis; Risk factors; Steroids; Supplements; Vasoconstrictor Agents - administration & dosage; United States
• ISSN: 0743-8346; 1476-5543
• DOI: 10.1038/sj.jp.7211193

Extremely low birth weight (ELBW) infants are at risk for hypotension. Abnormal adrenal function may play a role in the pathogenesis of hypotension, and therefore, the administration of hydrocortisone (HC) may be an effective treatment for hypotension in some infants. However, the efficacy of prophylactic HC to prevent the use of vasopressors for a defined hypotensive state has not been studied. We conducted a randomized-controlled trial to determine the potential role on adrenal insufficiency in early neonatal hypotension and to determine the effectiveness of prophylactic HC in reducing treatment of hypotension in ELBW infants. Infants were assigned to receive either HC or placebo within the first 3 hours of life. Therapy was continued for 5 days. The presence of hypotension was based on an operational definition and treatment with vasopressors (VP) was standardized based on an a priori protocol. A total of 34 patients were enrolled. Baseline characteristics were similar between groups. Of the HC group 25% received VP at 24 hours of age compared to 44% of the placebo group. On day of life 2, only 7% of the HC group received VP compared to 39% of the placebo group (p<0.05). Prophylactic treatment with HC reduces the incidence of hypotension, defined by treatment with VP, among ELBW infants during the first 2 days of life. However, the mounting evidence that prophylactic administration of glucocorticoids in the first days of life is harmful to ELBW infants makes HC prophylaxis unwise until the efficacy of treatment relative to safety can be clearly established.