Breast Feeding Clinical Trial
— UmbrelLACTOfficial title:
Clinical Lactation Study on the Exposure to Medicines Via Human Milk: an Umbrella Study Protocol
NCT number | NCT06042803 |
Other study ID # | S67204 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 1, 2023 |
Est. completion date | May 2025 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 - Willing to express and collect human milk - Signed informed consent to participate and for processing their personal data - For infants - Gestational age at birth: =24 weeks - Parental signed informed consent to participate and for processing their personal data Exclusion Criteria: - Maternal age <18 years - Mother of twins - Not meeting the inclusion criteria |
Country | Name | City | State |
---|---|---|---|
Belgium | Universitaire Ziekenhuizen KU Leuven | Leuven | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen KU Leuven | BELpREG, Innovative Medicines Initiative |
Belgium,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
24 hours (sampling day) | |
Secondary | 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) |
24 hours (sampling day) | |
Secondary | 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 |
24 hours (sampling day) | |
Secondary | 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 |
24 hours (sampling day) | |
Secondary | 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 |
24 hours (sampling day) | |
Secondary | The estimated intake of medicines in the nursing infant via human milk: Css, ave | The average infant medicine concentration at steady state (Css, ave)(ng/mL), if oral bioavailability (F) and drug clearance (CL) are known for the paediatric population
= oral bioavailability (F) x [eDID (mg/kg/d)/Clearance (CL; L/d)]x1000 |
24 hours (sampling day) | |
Secondary | The systemic exposure to medicines in the nursing infant via breastfeeding: infant systemic medicine concentration | The measured infant systemic medicine concentration if the parents give consent for collection of a blood sample from the infant; | 24 hours (sampling day) | |
Secondary | The systemic exposure to medicines in the nursing infant via breastfeeding: infant/maternal plasma ratio | The infant/maternal plasma ratio if a blood sample from the infant is available; | 24 hours (sampling day) | |
Secondary | The systemic exposure to medicines in the nursing infant via breastfeeding | Rate of medicine absorption in infants through human milk (e.g., infant plasma concentration/milk concentration) if a blood sample from the infant is available; | 24 hours (sampling day) | |
Secondary | The general health status (including possible adverse effects) of the nursing infant | The general health status of the infant, reported by maternal questionnaire. | 2 weeks (in case of an acute maternal treatment/condition) or 2 months (in case of an chronic maternal treatment/condition) | |
Secondary | Evaluation of physiologically-based pharmacokinetic (PBPK) models: Concentration-time profile | Evaluation of the predictive performance of PBPK models by assessing whether the observed concentration-time profiles were within the 5th-95th percentile of the population prediction of the PBPK models. | 24 hours | |
Secondary | Evaluation of physiologically-based pharmacokinetic (PBPK) models: M/P ratio | Evaluation of the predictive performance of PBPK models by assessing whether the observed Milk-to-plasma ratio were within the 5th-95th percentile of the population prediction of the PBPK models. | 24 hours | |
Secondary | Evaluation of physiologically-based pharmacokinetic (PBPK) models: Cmax | Evaluation of the predictive performance of PBPK models by assessing whether the observed maximum concentration (Cmax) were within the 5th-95th percentile of the population prediction of the PBPK models. | 24 hours | |
Secondary | Evaluation of physiologically-based pharmacokinetic (PBPK) models: AUC | Evaluation of the predictive performance of PBPK models by assessing whether the observed Area-under-the-curve (AUC) were within the 5th-95th percentile of the population prediction of the PBPK models. | 24 hours | |
Secondary | Evaluation of physiologically-based pharmacokinetic (PBPK) models: DID | Evaluation of the predictive performance of PBPK models by comparing the predicted daily infant dosage (DID) with the calculated DID [The daily infant dosage (DID)(mg/d) = ?(total drug concentration in each milk collection x expressed milk volume in each milk collection), calculated from the concentrations found in the human milk samples]. | 24 hours | |
Secondary | Evaluation of physiologically-based pharmacokinetic (PBPK) models: RID | Evaluation of the predictive performance of PBPK models by comparing the predicted relative infant dose (RID) with the calculated RID [The relative infant dose (RID)(%) = [eDID (mg/kg/d)/Maternal Dosage (mg/kg/d)] x 100]. | 24 hours |
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