Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGValganciclovir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGVenlafaxine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGDoxycycline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGLevofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGMethylphenidate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGSumatriptan
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGCitalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGCyclobenzaprine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGFurosemide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGGabapentin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGHydrochlorothiazide
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGHydroxyurea
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGRosuvastatin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGTopiramate
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGTrazodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGVerapamil
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGRemdesivir
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGAnakinra
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGTocilizumab
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGFluvoxamine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGAmoxicillin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGBupropion
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGDuloxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGHydrocodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGLevetiracetam
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGParoxetine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGBuprenorphine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGTranexamic acid (TXA)
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGlabetalol
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGmetformin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGnifedipine
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGclindamycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGoxycodone
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGazithromycin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGescitalopram
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGsertraline
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGondansetron
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
DRUGCiprofloxacin
Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
Sponsors
Duke University
The Emmes Company, LLC
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| M/P ratio | Until the infant becomes 180 days of age | 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. |
| DID | Until the infant becomes 180 days of age | 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. |
| RID | Until the infant becomes 180 days of age | 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. |
| I/M ratio | Until the infant becomes 180 days of age | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile of commonly used drugs in infants exposed to drugs in breastmilk | Until the infant becomes 180 days of age | see Cohort 1-31 for listing of drugs |
| AE | Up until 180 days of age | 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. |
| SAE | Up until 180 days of age | 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. |
| ESI | Until the infant becomes 180 days of age | 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 |
Countries
Canada, United States
Contacts
CONTACTEmily Forgey
CONTACTCheryl Alderman
PRINCIPAL_INVESTIGATORSamia Aleem, MD
Duke University
Outcome results
None listed