Journal article
A Randomized Controlled Study of Low-Dose Hydrocortisone Versus Placebo in Dopamine-Treated Hypotensive Neonates Undergoing Hypothermia Treatment for Hypoxic−Ischemic Encephalopathy
The Journal of pediatrics, Vol.211, pp.13-19.e3
08/2019
DOI: 10.1016/j.jpeds.2019.04.008
PMID: 31155392
Abstract
To investigate whether hydrocortisone supplementation increases blood pressure and decreases inotrope requirements compared with placebo in cooled, asphyxiated neonates with volume-resistant hypotension.
A double-blind, randomized, placebo-controlled clinical trial was conducted in a Level III neonatal intensive care unit in 2016-2017. Thirty-five asphyxiated neonates with volume-resistant hypotension (defined as a mean arterial pressure [MAP] < gestational age in weeks) were randomly assigned to receive 0.5 mg/kg/6 hours of hydrocortisone or placebo in addition to standard dopamine treatment during hypothermia.
More patients reached the target of at least 5-mm Hg increment of MAP in 2 hours after randomization in the hydrocortisone group, compared with the placebo group (94% vs 58%, P = .02, intention-to-treat analysis). The duration of cardiovascular support (P = .001) as well as cumulative (P < .001) and peak inotrope dosage (P < .001) were lower in the hydrocortisone group. In a per-protocol analysis, regression modeling predicted that a 4-mm Hg increase in MAP in response to hydrocortisone treatment was comparable with the effect of 15 μg/kg/min of dopamine in this patient population. Serum cortisol concentrations were low before randomization in both the hydrocortisone and placebo groups (median 3.5 and 3.3 μg/dL, P = .87; respectively), suggesting inappropriate adrenal function. Short-term clinical outcomes were similar in the 2 groups.
Hydrocortisone administration was effective in raising the blood pressure and decreasing inotrope requirement in asphyxiated neonates with volume-resistant hypotension during hypothermia treatment.
ClinicalTrials.gov: NCT02700828.
Details
- Title: Subtitle
- A Randomized Controlled Study of Low-Dose Hydrocortisone Versus Placebo in Dopamine-Treated Hypotensive Neonates Undergoing Hypothermia Treatment for Hypoxic−Ischemic Encephalopathy
- Creators
- Kata Kovacs - 1st Department of Pediatrics, Semmelweis University, Budapest, HungaryEniko Szakmar - 1st Department of Pediatrics, Semmelweis University, Budapest, HungaryUnoke Meder - 1st Department of Pediatrics, Semmelweis University, Budapest, HungaryLaszlo Szakacs - Planimeter Statistics Ltd, Budapest, HungaryAnna Cseko - 1st Department of Pediatrics, Semmelweis University, Budapest, HungaryBarbara Vatai - 1st Department of Pediatrics, Semmelweis University, Budapest, HungaryAttila J Szabo - 1st Department of Pediatrics, Semmelweis University, Budapest, HungaryPatrick J McNamara - University of Iowa Health Care, Iowa City, IAMiklos Szabo - 1st Department of Pediatrics, Semmelweis University, Budapest, HungaryAgnes Jermendy - 1st Department of Pediatrics, Semmelweis University, Budapest, Hungary
- Resource Type
- Journal article
- Publication Details
- The Journal of pediatrics, Vol.211, pp.13-19.e3
- Publisher
- Elsevier Inc
- DOI
- 10.1016/j.jpeds.2019.04.008
- PMID
- 31155392
- ISSN
- 0022-3476
- eISSN
- 1097-6833
- Language
- English
- Date published
- 08/2019
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology; Internal Medicine
- Record Identifier
- 9984093605902771
Metrics
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