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Caffeine trial aims to keep preterm babies breathing safely at home

NCT ID NCT06518603

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving caffeine citrate to moderately preterm infants for 28 days after hospital discharge can prevent apnea (breathing pauses) that lead to sick visits. About 340 babies in Zambia will receive either caffeine or a placebo daily. Researchers will also check if caffeine improves the babies' development at 12 months of age.

What this could mean

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

Active substance
caffeine citrate
What this could lead to
If it works, this could reduce dangerous breathing pauses and emergency visits in preterm babies after they go home, and possibly improve their development at one year.
What could go wrong
This is a Phase 4 trial, but it's still early to know if caffeine helps after discharge. The study is in one country (Zambia), so results may not apply everywhere. Caffeine can cause side effects like jitteriness or fast 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.

Phase

Phase 4

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

Participants

About 340 people

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

Started

Jun 2026

Expected to finish

Jun 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.

Ages

0 days to 12 months

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: Newborns: 1. 29 0/7 to 33 6/7 weeks GA (or with a birth weight 1.0 to 2.0 kg if pregnancy dating is unreliable) admitted to the UTH NICU, 2. On methylxanthines with plans to discontinue on methylxanthine, 3. Off oxygen therapy for \>48 hours at the time of evaluation for eligibility, 4. Receiving full daily feeds, 5. Deemed stable and ready to go off caffeine as recommended by the Neonatologist 6. 18+ years of age (parent) Exclusion Criteria: 1. Newborns with neuromuscular conditions affecting respiration, 2. Major congenital malformations and genetic disorders, 3. Unable to obtain parental or guardian consent

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Conditions

The condition(s) this trial relates to.

Apnea apnea of prematurity respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Apnea of prematurity Development, infant Premature infant disease

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • University Teaching Hospital

    RECRUITING

    Lusaka, Lusaka Province, 10100, Zambia

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