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Caffeine boost for preterm infants: faster feeding?

NCT ID NCT06327152

Symptom relief Sponsor: University of California, Irvine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving caffeine to preterm infants for a longer period helps them learn to feed by mouth sooner. About 80 babies born at 32 weeks or earlier will be enrolled. Researchers will compare time to full oral feeding and hospital discharge between those who continue caffeine and those who stop.

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 successful, this could show that longer caffeine use helps preterm babies reach full oral feeding sooner, potentially reducing hospital stays.
What could go wrong
This is a small Phase 2 trial, so results may not be conclusive. Caffeine can cause side effects like jitteriness or heart rate changes in infants.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

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

Started

Feb 2024

Expected to finish

Dec 2026

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.

Ages

1 week to 40 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: • Infants born at equal to or less than 32 weeks and 0 days gestational age AND * Equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment. * Off respiratory support for at least 2 days (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (CPAP), mechanical ventilation). * On caffeine and meet criteria to discontinue caffeine. * No significant cardiopulmonary events for at least 5 days (apnea \> 20 seconds, apnea with heart rate (HR) \< 80 beats per minute (bpm), HR \< 80 bpm with desaturation \< 85% or color change). Exclusion Criteria: * Infants with critical congenital heart disease. * Infants with neuromuscular conditions affecting respiration. * Infants with overt brain injury (i.e. severe Grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding. * Infants with major genetic disorders. * Infants with anatomic anomalies that will hinder oral feeding. * Infants who have already progressed to Step 3 (of 5) of our institution's oral feeding protocol (oral feeds 4 times per day). * Infants who develop necrotizing enterocolitis after enrollment. * Failure to obtain consent or declined by parents.

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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

Contacts and locations

Locations

  • UC Irvine Medical Center

    Orange, California, 92868, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.