At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy of Early Administration of Hydrocortisone in Shock in Preterm Neonates of Less Than 1,500 g
In Brief
A Phase 4 clinical trial evaluating Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days and Vasoactive drug therapies for Shock and 10 related conditions. Active but no longer recruiting, targeting 76 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to determine the effectiveness of early use of hydrocortisone (since the diagnosis of shock) for its resolution within the first 72 hours in premature infants under 1,500 g. The main questions it aims to answer are: * Does the early use of hydrocortisone help solve shock in preterm infants under 1500 g faster than the standard treatment? * Does the early use of hydrocortisone help prevent death within the first seven days of presentation of shock in comparison to premature infants who receive regular treatment? Researchers will compare the early use of hydrocortisone plus the standard treatment to solve shock against just standard treatment. Participants will: * Be randomized to receive standard treatment for shock according to their neonatologist or this standard treatment plus hydrocortisone as soon as the diagnosis is done and treatment is started. * Be followed either until shock is solved or if they present death due to this event of shock.
Study Details
Timeline
Interventions
The "Early Hydrocortisone Group" will be receiving Hydrocortisone since the diagnosis of shock and the vasoactive drugs are initiated.
This group will receive the treatment that the attending physician will decide. It may include any kind of vasoactive drug and, at some point, Hydrocortisone if the attending considers the patient is going through a "Vasoactive resistant shock".