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Could a steroid shot help tiny preemies survive shock?

NCT ID NCT07248761

Disease control Sponsor: Coordinación de Investigación en Salud, Mexico Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving the steroid hydrocortisone early, right when shock is diagnosed, helps very small preterm babies (under 1500 grams) recover faster. Researchers will compare babies who get standard shock treatment plus hydrocortisone to those who get standard treatment alone. The goal is to see if early hydrocortisone resolves shock within 72 hours and reduces death in the first week.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydrocortisone (a steroid hormone) given intravenously
What this could lead to
If it works, this could lead to a standard early treatment for shock in very small preterm babies, potentially saving lives in the first week.
What could go wrong
This is a small, single-country Phase 4 trial (76 babies). The benefit may be modest, and steroids carry risks like infection or high blood sugar in fragile newborns.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 76 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 14 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Preterm babies of 1,500 g or less * Diagnosis of shock by attending physician during their first 14 days of life Exclusion Criteria: * Major physical malformations that compromise life itself. * Preterm newborns with probable Congenital Adrenal Hyperplasia

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Conditions

The condition(s) this trial relates to.

acute respiratory distress syndrome hyperglycemia intestinal perforation necrotizing enterocolitis neonatal sepsis patent ductus arteriosus perinatal asphyxia Pulmonary Atelectasis Shock

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asphyxia perinatal Distress respiratory syndrome Hyperglycaemia (non diabetic) Intestinal perforation Nec - necrotizing enterocolitis Neonatal sepsis, early-onset Neonatal sepsis, late-onset Patent ductus arteriosus in preterm infants Preterm birth complication Preterm intraventricular hemorrhage Shock

Contacts and locations

Locations

  • UMAE Hospital de Gineco Obstetricia No. 4 "Luis Castelazo Ayala", IMSS

    Mexico City, ALVARO OBREGON, 01090, Mexico

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