Pharmacokinetics and Placental Transfer of Caffeine

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07570121
Phase
PHASE1
Status
Recruiting
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Conditions

  • Apnea of Prematurity
  • Bronchopulmonary Dysplasia
  • Premature Birth
  • Preterm Labor With Preterm Delivery
  • Respiratory Distress Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIP
Riley Hospital for ChildrenIndianapolisIndiana46202

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By research site
Riley Hospital for Children· Indianapolis, IN

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