OBJECTIVE: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. STUDY DESIGN: 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. RESULTS: 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). CONCLUSION: 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.
RCT Entities:
OBJECTIVE: 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. STUDY DESIGN: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. RESULTS: 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). CONCLUSION: 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.
Authors: Joe Brierley; Joseph A Carcillo; Karen Choong; Tim Cornell; Allan Decaen; Andreas Deymann; Allan Doctor; Alan Davis; John Duff; Marc-Andre Dugas; Alan Duncan; Barry Evans; Jonathan Feldman; Kathryn Felmet; Gene Fisher; Lorry Frankel; Howard Jeffries; Bruce Greenwald; Juan Gutierrez; Mark Hall; Yong Y Han; James Hanson; Jan Hazelzet; Lynn Hernan; Jane Kiff; Niranjan Kissoon; Alexander Kon; Jose Irazuzta; Jose Irazusta; John Lin; Angie Lorts; Michelle Mariscalco; Renuka Mehta; Simon Nadel; Trung Nguyen; Carol Nicholson; Mark Peters; Regina Okhuysen-Cawley; Tom Poulton; Monica Relves; Agustin Rodriguez; Ranna Rozenfeld; Eduardo Schnitzler; Tom Shanley; Saraswati Kache; Sara Skache; Peter Skippen; Adalberto Torres; Bettina von Dessauer; Jacki Weingarten; Timothy Yeh; Arno Zaritsky; Bonnie Stojadinovic; Jerry Zimmerman; Aaron Zuckerberg Journal: Crit Care Med Date: 2009-02 Impact factor: 7.598
Authors: Erika Fernandez; Kristi L Watterberg; Roger G Faix; Bradley A Yoder; Michele C Walsh; Conra Backstrom Lacy; Karen A Osborne; Abhik Das; Douglas E Kendrick; Barbara J Stoll; Brenda B Poindexter; Abbot R Laptook; Kathleen A Kennedy; Kurt Schibler; Edward F Bell; Krisa P Van Meurs; Ivan D Frantz; Ronald N Goldberg; Seetha Shankaran; Waldemar A Carlo; Richard A Ehrenkranz; Pablo J Sanchez; Rosemary D Higgins Journal: Am J Perinatol Date: 2014-02-10 Impact factor: 1.862