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ACTIVE NOT RECRUITING
NCT07248761
PHASE4

Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial

Sponsor: Coordinación de Investigación en Salud, Mexico

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

OTHER

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