Prospective, Randomized, Double-blind, Cohort Study of Hydrocortisone vs Placebo in Systemic Low Blood Pressure During Hypothermia Treatment in Asphyxiated Newborns (CORTISoL)

NCT02700828 Phase 2/Phase 3 COMPLETED

This is a prospective, randomized, double-blind, placebo controlled, single center study to compare low dose hydrocortisone vs placebo in systemic low blood pressure during hypothermia treatment in asphyxiated newborns. Patients will be allocated to one of the treatment arms (hydrocortisone or placebo) while receiving conventional inotropic therapy as needed. The hypothesis is that cooled asphyxiated neonates develop relative adrenal insufficiency that may contribute to hypotension and lower efficacy of inotropic therapy in this patient population. Thus, the investigators are planning to measure initial serum cortisol levels and investigate the cardiovascular effects of low dose hydrocortisone supplementation besides conventional inotropic therapy in a placebo-controlled fashion.

Details

Lead sponsor	Semmelweis University
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	32
Start date	2016-02
Completion	2022-12-15

Conditions

• Hypoxic-Ischemic Encephalopathy
• Asphyxia

Interventions

• Hydrocortisone
• Placebo

Primary outcomes

• Compare mean arterial blood pressure (MAP) change in the patients receiving hydrocortisone vs placebo — 2 hours
  Circulatory stability as measured by an increased MAP (5 mmHg) within two hours after drug administration

Countries

Hungary