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Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
Sponsor: Coordinación de Investigación en Salud, Mexico
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.
Official title: Efficacy of Early Administration of Hydrocortisone in Shock in Preterm Neonates of Less Than 1,500 g
Key Details
Gender
All
Age Range
0 Days - 14 Days
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2025-02-01
Completion Date
2026-07-30
Last Updated
2025-11-25
Healthy Volunteers
No
Conditions
Interventions
Intravascular Hydrocortisone (stress dosage): 1 mg/k/dose each 8 hours for 5 days
The "Early Hydrocortisone Group" will be receiving Hydrocortisone since the diagnosis of shock and the vasoactive drugs are initiated.
Vasoactive drug therapies
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".
Locations (1)
UMAE Hospital de Gineco Obstetricia No. 4 "Luis Castelazo Ayala", IMSS
Mexico City, ALVARO OBREGON, Mexico