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Caffeine study aims to help preterm babies breathe easier

NCT ID NCT07570121

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how a pregnant woman's body handles caffeine and how much of it reaches her unborn baby. Researchers will give a small dose of caffeine to 30 women at risk of preterm delivery before a planned C-section. Blood samples from the mother, placenta, and newborn will help create a computer model of caffeine metabolism during pregnancy. The goal is to learn how to use caffeine safely to treat breathing problems in premature 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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 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

18 years and older

Sex

Female participants only

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: 1. Pregnant women with risk of preterm delivery at 23 - 31+6 weeks with singleton gestation who are inpatient without a plan for discharge before delivery. 2. Informed consent provided for participation. 3. Cesarean delivery. Exclusion Criteria: 1. Known major fetal congenital anomalies or genetic disorders. 2. Plan in place for limited neonatal resuscitation or comfort care only. 3. Preterm, premature rupture of membranes prior to 22 weeks gestation with concern for pulmonary hypoplasia. 4. Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorder. 5. Fetal arrhythmia. 6. Seizure disorder. 7. Oligohydramnios due to renal anomalies or renal impairment. 8. Current or anticipated use of products that include sodium benzoate. 9. Maternal age \<18 years. 10. Maternal medical conditions in which caffeine or other stimulants would be contraindicated. 11. High likelihood of receiving terbutaline. 12. Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide. 13. Significant acute or chronic medical, neurologic, or illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.

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Conditions

The condition(s) this trial relates to.

adult acute respiratory distress syndrome Apnea apnea of prematurity bronchopulmonary dysplasia Obstetric Labor, Premature Premature Birth 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 Bronchopulmonary dysplasia Premature birth Preterm labor with preterm delivery Respiratory distress syndrome

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

  • Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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