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Caffeine could steady preemie hearts, tiny study hopes

NCT ID NCT07274969

Symptom relief Sponsor: Assiut University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 will check if caffeine, already used to treat breathing pauses in premature babies, also helps keep their heart rate and blood pressure steady. Researchers will monitor 40 preterm infants in the NICU before and after caffeine treatment. The goal is to see if caffeine improves cardiovascular stability in these fragile newborns.

What this could mean

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

Active substance
caffeine
What this could lead to
If it works, this could show that caffeine helps keep preterm babies' hearts and blood pressure stable while treating their breathing pauses.
What could go wrong
This is a small, early study with only 40 babies, so results may not apply to all preterm infants. Caffeine can cause side effects like rapid heart rate.

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.

Participants

About 40 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Preterm neonates receiving standard caffeine citrate therapy for apnea of prematurity, including a loading dose of 20-25 mg/kg followed by maintenance dosing (5-10 mg/kg daily). Cardiovascular parameters and side effects are monitored longitudinally.

Ages

Up to 37 weeks

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 neonates with gestational age \<37 weeks * Receiving caffeine therapy for apnea of prematurity * Hemodynamically stable before caffeine initiation Exclusion Criteria: * Presence of major congenital anomalies * Use of vasopressors at baseline * Severe intraventricular hemorrhage (Grade III-IV)

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Conditions

The condition(s) this trial relates to.

Apnea apnea of prematurity

As listed by the trial registrant

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

Apnea of prematurity Preterm neonates

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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