RECRUITING

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.

Official Title

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Quick Facts

Study Start:2018-10-04
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03511118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * 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.
  1. * 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.
  2. * Known pregnancy during PK sampling.

Contacts and Locations

Study Contact

Emily Forgey
CONTACT
919-660-8720
emily.forgey@duke.edu
Cheryl Alderman
CONTACT
919-966-8349
cheryl.alderman@duke.edu

Principal Investigator

Kanecia Zimmerman, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

University of California-San Diego Medical Center
La Jolla, California, 92093
United States
Loma Linda University Health
Loma Linda, California, 92354
United States
Northwestern University
Chicago, Illinois, 60611
United States
Ann and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60614
United States
Indiana University Health
Indianapolis, Indiana, 46202
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Children's Hospital and Clinics - Minneapolis
Minneapolis, Minnesota, 55404
United States
University of New Mexico, Health Sciences Center
Albuquerque, New Mexico, 87131
United States
University of North Carolina Hospital
Chapel Hill, North Carolina, 27599
United States
Duke University Maternal and Fetal Medicine
Durham, North Carolina, 27705
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213
United States
Texas Tech University Health Sciences Center School of Medicine.
Amarillo, Texas, 79106
United States
University of Texas Medical Branch - Galveston
Galveston, Texas, 77555
United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
The Women's Hospital of Texas
Houston, Texas, 77054
United States
University of Texas Health Science Center
San Antonio, Texas, 78229
United States
University of Utah
Salt Lake City, Utah, 84132
United States
University of Washington
Seattle, Washington, 98195-7630
United States

Collaborators and Investigators

Sponsor: Duke University

  • Kanecia Zimmerman, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-04
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2018-10-04
Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Lactating Women on Select DOI
  • Breastfed Infants of Mothers on Select DOI