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New study reveals how prescription drugs transfer to breastmilk

NCT ID NCT03511118

Knowledge-focused Sponsor: Duke University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times

Summary

This study looks at how common prescription drugs move from a mother's body into her breastmilk and how much reaches her baby. Researchers will measure drug levels in milk and blood samples from 1,600 breastfeeding women and their infants. The goal is to provide better safety information for mothers who need medication while nursing.

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.

Participants

About 1,600 people

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

Started

Oct 2018

Expected to finish

Jul 2028

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.

Who is studied

Lactating women receiving DOIs per SOC, as prescribed by their healthcare providers, and their breastfed infants.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk. * Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines. Exclusion Criteria: * Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study. * Known pregnancy during PK sampling.

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As listed by the trial registrant

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

Breastfed infants of mothers on select doi Lactating women on select doi

How to take part

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

  1. The places running it

    13 sites. 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

  • Ann and Robert H. Lurie Childrens Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60614, United States

  • Centre Hospitalier Universitaire Sainte-Justine

    COMPLETED

    Montreal, Quebec, H3T IC5, Canada

  • Children's Hospital and Clinics - Minneapolis

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • Duke University Maternal and Fetal Medicine

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine

    COMPLETED

    Philadelphia, Pennsylvania, 19104, United States

  • Indiana University Health

    COMPLETED

    Indianapolis, Indiana, 46202, United States

  • Lawson Health Research Institute

    COMPLETED

    London, Ontario, N6A 5W9, Canada

  • Loma Linda University Health

    RECRUITING

    Loma Linda, California, 92354, United States

  • Northwestern University

    COMPLETED

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Texas Tech University Health Sciences Center School of Medicine.

    RECRUITING

    Amarillo, Texas, 79106, United States

  • The Women's Hospital of Texas

    RECRUITING

    Houston, Texas, 77054, United States

  • University of California-San Diego Medical Center

    RECRUITING

    La Jolla, California, 92093, United States

  • University of Iowa Hospitals and Clinics

    ACTIVE_NOT_RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of New Mexico, Health Sciences Center

    COMPLETED

    Albuquerque, New Mexico, 87131, United States

  • University of North Carolina Hospital

    COMPLETED

    Chapel Hill, North Carolina, 27599, United States

  • University of Pittsburgh School of Medicine

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Texas Health Science Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Medical Branch - Galveston

    RECRUITING

    Galveston, Texas, 77555, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • University of Washington

    COMPLETED

    Seattle, Washington, 98195-7630, United States