Recruiting
Phase 1

Caffeine

Sponsor:

Indiana University

Code:

NCT07570121

Conditions

Preterm Labor With Preterm Delivery

Premature Birth

Apnea of Prematurity

Respiratory Distress Syndrome

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Caffeine citrate

Study Details

Brief summary:

The goal of this study is to learn how a pregnant person's body processes caffeine and how much caffeine crosses the placenta to the baby. A small dose of caffeine will be given to each pregnant participant before delivery. Blood will be drawn to measure caffeine levels in the pregnant mother. Blood will also be taken from the placenta and from the newborn to measure caffeine levels. This data will be used to form a computer model of the metabolism of caffeine during pregnancy.

Conditions

Preterm Labor With Preterm Delivery

Premature Birth

Apnea of Prematurity

Respiratory Distress Syndrome

Bronchopulmonary Dysplasia

Study ID

NCT07570121

Start date

Jun 1, 2026

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Antenatal Caffeine

A single dose of caffeine citrate will be given intravenously within approximately 1 hour prior to delivery. Caffeine and metabolite levels will be measured from blood samples drawn pre-dose and post-dose in pregnant participants, from cord blood, and from the neonate.

Interventions

Caffeine citrate

A single dose of 100 mg of caffeine citrate will be given to each pregnant participant.

Primary outcome measure

  • Pharmacokinetics of caffeine in pregnancy [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Locations

Riley Hospital for Children

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Anna Thomas, MD

More Information

Sponsor

Indiana University

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • caffeine
  • preterm labor
  • prematurity
  • pharmacokinetics
  • bronchopulmonary dysplasia
  • apnea of prematurity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-04.