UmbrelLACT Study: Clinical Lactation Study on the Exposure to Medicines Via Human Milk
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
The goal of this observational study is to determine the concentration of medicines in human milk during maternal medicine intake. The main questions it aims to answer are:
* What is the concentration of maternal medicines in human milk? * What is the (estimated) intake and exposure in the breastfed infant?
Participants will be asked to
* fill out a questionnaire regarding medical data of the mother and child * track medication intake for 3 days * collect milk samples during 24 hours * optionally, donate 2 blood samples of the mother and give consent to one blood sample of the child * fill out a questionnaire regarding the general health of the child.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
For breastfeeding women
Maternal age: ≥ 18 year
Currently exclusively or partially breastfeeding (/expressing milk) at the time of milk sampling
Using medicines for any indication, with at least 5 half-lives of the medicine taken
Disqualifiers
Maternal age <18 years
Mother of twins
Not meeting the inclusion criteria
Trial population
Clinicians from University Hospitals Leuven and other healthcare facilities can give women who are breastfeeding or expressing milk and are actively taking maternal medicines, the contact information of the study team. Furthermore, the study background and contact information of the study team are available through the BELgPREG project (www.belpreg.be), a research initiative on the use of medicines during pregnancy. The study team will not interfere with the decision to prescribe medicines or to breastfeed. If interested, women can contact a study team member who will plan an information moment (by phone or video call) to explain the study and informed consent. Healthy volunteers are healthy breastfeeding women, \>18 years and willing to donate a milk sample and optionally a plasma sample.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Human milk collection
Other interventionEvery time the mother would normally feed the child, we ask to collect the total milk volume for the feed from both breasts by an electric pump. For each collection, the volume and time will be noted, the container will be inverted and 5 to 10ml of that volume will be transferred in a polypropylene test tube or other tube type depending on the type of compounds (=sample to determine drug concentration in milk) for analysis (max 10% of the collected volume of each feed). The participant decides how the remainder of the collected milk is used. The milk samples will immediately be stored in the refrigerator (4°C) after being labeled. The samples will be collected by one of the investigators within 24 hours, will be transported on ice and frozen at -80°C until analysis.
Optionally: maternal blood sample
Other interventionBlood collection to determine the drug concentration in plasma (6 to 10mL EDTA or other tube type, depending on the type of compound) will be performed at least within 1 hour interval with the first feeding (pumping) after medication intake, and 24 hours after medication intake (with preferable milk collection within 1 hour of blood sampling). The sample label, date and time of sampling will be noted.
Optionally: child blood sample
Other interventionBlood collection of the infant to determine systemic exposure of child(1-5% of the total blood volume, according to the FDA guidelines, in an EDTA or other tube type, depending on the type of compound,) will be performed at the same day as the maternal sampling, if parental consent is obtained. The sample label, date and time of sampling will be noted.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
The concentration of maternal medicines in human milk
* Quantification of the concentration of medicines in human milk: concentration, milk-to-plasma (M/P) ratio; * The PK parameters of medicines and relevant metabolites in human milk: area under the milk concentration-time curve (AUC), the average concentration (AUC divided by dosing interval), peak and trough milk concentrations (if available, depending on dosing regimen and lactation regimen), and time to reach peak milk concentration. * The PK parameters of medicines and relevant metabolites in plasma from lactating women compared to available scientific literature results, such as AUC, peak plasma concentration, time to peak plasma concentration, plasma clearance or apparent oral clearance, apparent volume of distribution and terminal half-life.
Time frame
24 hours (sampling day)Secondary outcomes
1
The estimated intake of medicines in the nursing infant via human milk: DID
The daily infant dosage (DID)(mg/d) = ∑(total drug concentration in each milk collection x expressed milk volume in each milk collection)
Time frame
24 hours (sampling day)2
The estimated intake of medicines in the nursing infant via human milk: eDID - maxDID
The estimated Daily infant dosage (eDID)(mg/kg/d) and the infant risk (maxDID) expressed as a daily weight normalized dose (mg/kg/d), with 150mL/kg/d and 200mL/kg/d as maximum estimated milk intake, respectively. The calculation of the M/P ratio is based on the AUC on multiple time points, if possible. = M/P ratio x average plasma concentration x estimated milk intake
Time frame
24 hours (sampling day)3
The estimated intake of medicines in the nursing infant via human milk: RID
The relative infant dose (RID)(%) = \[eDID (mg/kg/d)/Maternal Dosage (mg/kg/d)\] x 100
Time frame
24 hours (sampling day)4
The estimated intake of medicines in the nursing infant via human milk: RIDtherapeutic
The relative infant therapeutic dose (RIDtherapeutic)(%) = \[estimated daily infant dosage (mg/kg/d)/Daily therapeutic infant dosage (mg/kg/d)\] x 100
Time frame
24 hours (sampling day)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Innovative Medicines Initiative
Collaborator
BELpREG
Collaborator
Source ClinicalTrials.gov