Pharmacokinetics and Placental Transfer of Caffeine

NCT07570121 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 27709176798
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of caffeine in pregnancy

  Caffeine and primary metabolite concentrations will be determined in maternal plasma samples. Caffeine, paraxanthine, theophylline, and theobromine will be analyzed by HPLC-MS/MS (Sciex 6500) by the Indiana University Simon Comprehensive Cancer Center (IUSCCC)Clinical Pharmacology Analytical Core Laboratory. Pharmacokinetic modeling will be supported by the Indiana Clinical and Translational Sciences Institute Pharmacometric Modeling and Simulation Program. This model will be utilized to predict the maternal dose of caffeine required to achieve therapeutic concentrations in the neonate at the time of delivery.

  3 hours

Secondary Outcomes (1)

• Placental transfer of caffeine

  1 hour

Study Arms (1)

Antenatal Caffeine

OTHER

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.

Drug: Caffeine citrate

Interventions

Caffeine citrate DRUG

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

Antenatal Caffeine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Informed consent provided for participation.
• Cesarean delivery.

You may not qualify if:

• Known major fetal congenital anomalies or genetic disorders.
• Plan in place for limited neonatal resuscitation or comfort care only.
• Preterm, premature rupture of membranes prior to 22 weeks gestation with concern for pulmonary hypoplasia.
• Pre-eclampsia, gestational hypertension, or other gestational hypertensive disorder.
• Fetal arrhythmia.
• Seizure disorder.
• Oligohydramnios due to renal anomalies or renal impairment.
• Current or anticipated use of products that include sodium benzoate.
• Maternal age \<18 years.
• Maternal medical conditions in which caffeine or other stimulants would be contraindicated.
• High likelihood of receiving terbutaline.
• Use of the following medications, which may affect caffeine metabolism: fluvoxamine, ciprofloxacin, methoxsalen, mexiletine, vemurafenib, phenytoin, rifampin, and teriflunomide.
• 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.

Sponsors & Collaborators

• Indiana University: lead
• Indiana Clinical and Translational Sciences Institute: collaborator

MeSH Terms

Conditions

Premature Birth; Apnea; Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Obstetric Labor, Premature

Interventions

caffeine citrate

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anna Thomas, MD

  Indiana University, Riley Hospital for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna E Thomas, MD

CONTACT

800-248-1199; aeschwar@iu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics

Model Details: This study will include a single intervention group, divided into 3 cohorts across the range of gestational ages of interest.

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 6, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04