Breast FeedingNCT05543122
Drug Concentrations in Breast Milk and Prediction of Blood Levels of the Breastfed Infants
An observational study of Breast Feeding, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
There is a significant lack of information on drug secretion into milk and infant exposure. As a first step to address this issue, the investigators examine milk concentrations of selected drugs prescribed to breastfeeding women, which lack milk excretion data. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Feeding
- What is being tested?
- either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe
- How many people
- 39 participants
- Where
- 1 siteCanada
- Study dates
- 9 Mar 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Lactating women over the age of 18 who are taking one of the study medications at steady state. Potential participants (breastfeeding women) will be identified by the clinics of collaborators and if interested in participation their verbal consent will be obtained to share their contact information with the study team. Participation of breastfed infants of the mother is optional.
Who may be able to join
- Age of 18 years or older
- Lactating women taking at least one of the study target drugs per Standard of Care
- Obtained informed consent
- Ability to communicate in English
- Older than 1 week
- Healthy
Who cannot join
- Any concomitant medication
- Known pregnancy during PK sampling
- Concomitant medical treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Drugs in Breast Milk
There is a significant lack of information on drug secretion into milk and infant exposure. As a first step to address this issue, the investigators examine milk concentrations of selected drugs prescribed to breastfeeding women, which lack milk excretion data. Milk data will be analyzed using population pharmacokinetic approaches, when possible, and acquired data of drug concentration profiles in milk will be combined with infant physiologically-based pharmacokinetic (PBPK) models to predict infant exposure levels.
Read the detailed description
In this study the investigators measure drug concentrations in breast milk (and optional blood) samples collected through sparse and flexible sampling strategy mitigating intense approaches of conventional PK study. Whenever possible, population PK method is used to characterize milk concentration profiles of the selected drugs. The obtained data is further processed through a PBPK model of infant to predict infant drug exposure levels.
The study also includes an optional pharmacogenetic part. This will allow the investigators to understand how variations in genetic composition plays role in breaking down drugs and how it affects the drug transfer into breast milk.
This study is conducted at three sites: Hospital for Sick Children (leading site), CHU Sainte Justine Hospital, Montreal (Study Lab: for drug measurement), and University of Waterloo (Modelling Core: to create computer model).
- Conditions
- Breast Feeding
- Being tested
- either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or EzetimibeDrug
Also called Typical brand names include, but not limited to: Tenoretic, Wellbutrin, Zyban, Briviact, Cipralex, Lexapro, Diflucan, Vimpat, Lamictal, Keppra, Trexall, Xatmep, Ezetrol, Nexlizet
This is a cohort study of pharmacokinetics of drugs in milk. Participants in the group are those breastfeeding women on the listed drugs at steady state, who are prescribed these drugs for clinical reasons outside this study framework.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding women | Either of the following drugs at steady state (Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe). Receives: Drug: either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentrations of target drugs in breast milk
using assays of drug concentrations validated in human milk as a matrix
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start9 Mar 2022
- Primary completion23 Dec 2023
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- St. Justine's Hospital, University of Waterloo
- Responsible party
- Principal investigator, Shinya Ito, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543122
- Sponsor's protocol ID
- 1000062184
- Status last verified
- Apr 2024
- First submitted
- 13 Sep 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drugs in Breast Milk
- ClinicalTrials.gov ID
- NCT05543122
- Acronym / sponsor ID
- 1000062184
- Conditions
- Breast Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- St. Justine's Hospital, University of Waterloo
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 16 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a significant lack of information on drug secretion into milk and infant exposure. As a first step to address this issue, the investigators examine milk concentrations of selected drugs prescribed to breastfeeding women, which lack milk excretion data. Milk data will be analyzed using population pharmacokinetic approaches, when possible, and acquired data of drug concentration profiles in milk will be combined with infant physiologically-based pharmacokinetic (PBPK) models to predict infant exposure levels.
Detailed description
In this study the investigators measure drug concentrations in breast milk (and optional blood) samples collected through sparse and flexible sampling strategy mitigating intense approaches of conventional PK study. Whenever possible, population PK method is used to characterize milk concentration profiles of the selected drugs. The obtained data is further processed through a PBPK model of infant to predict infant drug exposure levels.
The study also includes an optional pharmacogenetic part. This will allow the investigators to understand how variations in genetic composition plays role in breaking down drugs and how it affects the drug transfer into breast milk.
This study is conducted at three sites: Hospital for Sick Children (leading site), CHU Sainte Justine Hospital, Montreal (Study Lab: for drug measurement), and University of Waterloo (Modelling Core: to create computer model).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding women | – | Drug: either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or EzetimibeEither of the following drugs at steady state (Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or Ezetimibe). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lactating women over the age of 18 who are taking one of the study medications at steady state. Potential participants (breastfeeding women) will be identified by the clinics of collaborators and if interested in participation their verbal consent will be obtained to share their contact information with the study team. Participation of breastfed infants of the mother is optional.
Key inclusion criteria (6 listed)
- Age of 18 years or older
- Lactating women taking at least one of the study target drugs per Standard of Care
- Obtained informed consent
- Ability to communicate in English
- Older than 1 week
Key exclusion criteria (3 listed)
- Any concomitant medication
- Known pregnancy during PK sampling
- Concomitant medical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| either of Atenolol, Bupropion, Brivaracetam, Escitalopram, Fluconazole, Lacosamide, Lamotrigine, Levetiracetam, Methotrexate or EzetimibeAlso: Typical brand names include, but not limited to: Tenoretic, Wellbutrin, Zyban, Briviact, Cipralex, Lexapro, Diflucan, Vimpat, Lamictal, Keppra, Trexall, Xatmep, Ezetrol, NexlizetThis is a cohort study of pharmacokinetics of drugs in milk. Participants in the group are those breastfeeding women on the listed drugs at steady state, who are prescribed these drugs for clinical reasons outside this study framework. | Drug | Breastfeeding women |
Primary outcome
concentrations of target drugs in breast milk
Time frame: an average of 1 year
using assays of drug concentrations validated in human milk as a matrix
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
Related trials for Breast Feeding
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
Recruiting
Effects of a Mindful Self-Compassion Intervention on Psychological Adjustment in Breast Cancer Survivors
Breast Cancer
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Feeding, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentrations of target drugs in breast milk (time frame: an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.