NCT02700828

Hydrocortisone Treatment In Systemic Low Blood Pressure During Hypothermia in Asphyxiated Newborns

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Semmelweis University · Academic / Other
• Sex: All
• Age: 72 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

Hypothesis: The researchers hypothesized that asphyxiated neonates undergoing therapeutic hypothermia develop relative adrenal insufficiency that contributes to "late onset" (\>24 hours after birth) hypotension resistant to optimized pharmacological support. Thus, the investigators are planning to measure initial serum cortisol levels and investigate the cardiovascular effects of low dose hydrocortisone supplementation. Specific aims: 1. To study initial serum cortisol levels in asphyxiated newborns undergoing therapeutic hypothermia with late onset hypotension. 2. To demonstrate that in asphyxiated newborns undergoing therapeutic hypothermia and presenting with systemic hypotension resistant to optimized pharmacological support, low dose hydrocortisone supplementation restores normal blood pressure when compared to placebo. Methodology: * Prospective, randomized, double-blind, single center, cohort study * 1st Department of Paediatrics, NICU, Semmelweis University, Hungary * Starting date: 02/14/2016 * Patient number: 16 vs 16 (hydrocortisone vs placebo - based on previous observational study results) * Intervention (hydrocortisone vs placebo) applied only during therapeutic hypothermia (max. 72 hours) * Neurodevelopmental follow-up visit: Bayley II/III scale to evaluate the effect of hydrocortisone treatment on the neurological development at the age between 18 and 22 months. Drugs for hypotension, the hydrocortisone protocol: 1. Fluid replacement (volume bolus: 10-20 ml/kg isotonic saline, over 15 minutes, according to the clinician's decision) 2. In case of persisting hypotension: serum sample is collected for cortisol measurement. 3. Randomization, irrespective of actual cortisol level. As the study is blinded, enrollment in the clinical trial will/shall not influence the clinical decision making about further interventions. A dedicated study assistant will be available to prepare the drug / placebo for the newborns. * Inotropic therapy (dopamine, following the standard titration protocol) * AND (at start of dopamine) hydrocortisone: 4 \* 0,5 mg/kg /24 hours (in every 6 hours) or placebo administration (the corresponding amount of isotonic saline) 4. After randomization, intervention is continued until the end of hypothermia treatment (max. 72 hours), with the same dose. Inotropic therapy will be titrated as needed.

Conditions

• Hypoxic-Ischemic Encephalopathy
• Asphyxia

Interventions

Type	Name	Description
DRUG	Hydrocortisone	4 \* 0,5 mg/kg /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)
DRUG	Placebo	4 \* 2 ml isotonic sodium chloride solution /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-11-01
• Completion: 2022-12-15
• First posted: 2016-03-07
• Last updated: 2023-04-21

Locations

1 site across 1 country: Hungary