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.
The purpose of this study is to understand if the study drugs of interest are found in breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants and what effect this may have on infants; and to share what we learn with other researchers. The study drugs of interest have Food and Drug Administration (FDA) approval, but there is little or no information about the amount of drug found in the breastmilk of mothers who take them; the amount of drug that may be transferred to their infant's through breastmilk; or the effects this transfer may have on their infants. During this study we will ask to collect breastmilk and blood from mothers, and blood from infants, to measure the amount of study drug of interest in these body fluids. Results from this study will help researchers better understand how much of the study drug of interest is in your blood and breastmilk, and how much of the study drug of interest may be in your infant's blood because of breastfeeding.
Study Type
OBSERVATIONAL
Enrollment
1,600
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
University of California-San Diego Medical Center
La Jolla, California, United States
RECRUITINGLoma Linda University Health
Loma Linda, California, United States
RECRUITINGNorthwestern University
Chicago, Illinois, United States
COMPLETEDAnn and Robert H. Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGIndiana University Health
Indianapolis, Indiana, United States
COMPLETEDUniversity of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
ACTIVE_NOT_RECRUITINGChildren's Hospital and Clinics - Minneapolis
Minneapolis, Minnesota, United States
RECRUITINGUniversity of New Mexico, Health Sciences Center
Albuquerque, New Mexico, United States
COMPLETEDUniversity of North Carolina Hospital
Chapel Hill, North Carolina, United States
COMPLETEDDuke University Maternal and Fetal Medicine
Durham, North Carolina, United States
RECRUITING...and 12 more locations
M/P ratio
Characterize the pharmacokinetics using maternal milk/plasma exposure ratio is calculated by dividing the BMS01 drug of interest breastmilk concentration by the BMS01 drug of interest in maternal plasma concentration.
Time frame: Until the infant becomes 180 days of age
DID
Pharmacokinetics is characterized by estimated daily infant dose-daily infant dose which estimates the quantity of drug delivered to an infant via breastmilk in a given day.
Time frame: Until the infant becomes 180 days of age
RID
Pharmacokinetics is characterized by relative infant dose is a method of relating the potential dose of the drug delivered to the infant to the typical therapeutic dose given to the mother.
Time frame: Until the infant becomes 180 days of age
I/M ratio
Pharmacokinetics is characterized using infant maternal/exposure ratio. IM ratio is calculated using the average infant plasma concentration of the BMS01 drug of interest and historical value of clearance in infants.
Time frame: Until the infant becomes 180 days of age
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk
see Cohort 1-31 for listing of drugs
Time frame: Until the infant becomes 180 days of age
AE
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Adverse Events(AE) which are collected at each time point when the study-specific procedure occurred and up until 1 hour after.
Time frame: Up until 180 days of age
SAE
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Serious Adverse Events which are directly related to study procedures and were recorded from participants (infant or mother) at each time point when the study-specific procedure occurred and up until 1 hour after.
Time frame: Up until 180 days of age
ESI
Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Events of Special Interest(ESI) which include any pre-specified safety event that could be related to BMS01 drug of interest exposure. ESI's are only assessed for infants and only at study visits from the time the BMS01 DOI was initiated in mother and infant began breast milk feeding through the end of the study / infant age ≤ 180 days
Time frame: Until the infant becomes 180 days of age
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