Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns (NCT02700828) | Clinical Trial Compass
CompletedPhase 2/3
Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns
Hungary32 participantsStarted 2016-02
Plain-language summary
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.
Who can participate
Age range72 Hours
SexALL
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Inclusion criteria
✓. The infant will be assessed sequentially by criteria A, B and C, as described by the TOBY trial and listed below, to be eligible for hypothermia treatment.
✓. Invasive arterial blood pressure measurement: umbilical arterial catheter or peripheral arterial catheter to measure invasively the arterial blood pressure.
✓. During hypothermia treatment low blood pressure was detected and treated with the following:
✓. A written informed consent has been obtained from a parent of each infant after explanation of the study.
Exclusion criteria
✕. Signed informed consent is unavailable.
✕. Infants who are expected to be \> 6 hours of age (not suitable for cooling).