Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Ra… (NCT07248761) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Early Hydrocortisone Versus Regular Treatment in Shock in Extremely Preterm Neonates - an Open Randomized Controlled Trial
Mexico76 participantsStarted 2025-02-01
Plain-language 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.
Who can participate
Age range
0 Days – 14 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Shock resolution
Timeframe: 72 hours
Trial details
NCT IDNCT07248761
SponsorCoordinación de Investigación en Salud, Mexico