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

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.

Conditions

• Shock
• Preterm Birth Complication
• Preterm Intraventricular Hemorrhage
• Asphyxia Perinatal
• Distress Respiratory Syndrome
• Hyperglycaemia (Non Diabetic)
• Neonatal Sepsis, Early-Onset
• Neonatal Sepsis, Late-Onset
• NEC - Necrotizing Enterocolitis
• Patent Ductus Arteriosus in Preterm Infants
• Intestinal Perforation

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".

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social

  collaborator OTHER_GOV

• Coordinación de Investigación en Salud, Mexico

  lead OTHER_GOV

Principal Investigators

• ELISA DORANTES ACOSTA, PH D HEALTH SCIENCES · Hospital Infantil de Mexico Federico Gomez

• EDITH VALDEZ MARTINEZ, PH D MEDICAL ETHICS · Unidad de Investigación Médica en Epidemiología Clínica, UMAE Hospital de Pediatría, CMN SXXI, IMSS

• HORACIO MARQUEZ GONZALEZ, PH D HEALTH SCIENCES · Unidad de investigación, Hospital Infantil de México Federico Gómez / Cardiopatías Congénitas, UMAE Hospital de Cardiología, CMN SXXI, IMSS.

• ADRIANA APOLONIO, MARTINEZ · Servicio de Cardiología Pediátrica y Perinatal de la UMAE HGO4, IMSS

• MARIA DEL CARMEN JIMENEZ MARTINEZ, PH D IMMUNOLOGY · POSGRADO EN CIENCIAS MÉDICAS DE LA FACULTAD DE MEDICINA DE LA UNAM

• FLOR DE MARIA GRANADOS CANSECO, MASTER´S D HEALTH SCIENCES · UMAE, HOSPITAL DE GINECO-OBSTETRICIA NO. 4 "LUIS CASTELAZO AYALA", IMSS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

0 Days

Max Age

14 Days

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2026-06-30

Completion

2026-07-30

Countries

• Mexico

Study Locations