Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project
Introduction Breastfeeding is beneficial for the health of the mother and child. However, at least 50% of postpartum women need pharmacotherapy, and this number is rising due to the increasing prevalence of chronic diseases and pregnancies at a later age. Making informed decisions on medicine use wh...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-04-01
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| Series: | BMJ Paediatrics Open |
| Online Access: | https://bmjpaedsopen.bmj.com/content/8/1/e002385.full |
| _version_ | 1797215086242168832 |
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| author | Karel Allegaert Anne Smits Kristel Van Calsteren Pieter Annaert An Eerdekens Martje Van Neste Nina Nauwelaerts Michael Ceulemans |
| author_facet | Karel Allegaert Anne Smits Kristel Van Calsteren Pieter Annaert An Eerdekens Martje Van Neste Nina Nauwelaerts Michael Ceulemans |
| author_sort | Karel Allegaert |
| collection | DOAJ |
| description | Introduction Breastfeeding is beneficial for the health of the mother and child. However, at least 50% of postpartum women need pharmacotherapy, and this number is rising due to the increasing prevalence of chronic diseases and pregnancies at a later age. Making informed decisions on medicine use while breastfeeding is often challenging, considering the extensive information gap on medicine exposure and safety during lactation. This can result in the unnecessary cessation of breastfeeding, the avoidance of pharmacotherapy or the off-label use of medicines. The UmbrelLACT study aims to collect data on human milk transfer of maternal medicines, child exposure and general health outcomes. Additionally, the predictive performance of lactation and paediatric physiologically based pharmacokinetic (PBPK) models, a promising tool to predict medicine exposure in special populations, will be evaluated.Methods and analysis Each year, we expect to recruit 5–15 breastfeeding mothers using pharmacotherapy via the University Hospitals Leuven, the BELpREG project (pregnancy registry in Belgium) or external health facilities. Each request and compound will be evaluated on relevance (ie, added value to available scientific evidence) and feasibility (including access to analytical assays). Participants will be requested to complete at least one questionnaire on maternal and child’s general health and collect human milk samples over 24 hours. Optionally, two maternal and one child’s blood samples can be collected. The maternal medicine concentration in human milk will be determined along with the estimation of the medicine intake (eg, daily infant dose and relative infant dose) and systemic exposure of the breastfed child. The predictive performance of PBPK models will be assessed by comparing the observed concentrations in human milk and plasma to the PBPK predictions.Ethics and dissemination This study has been approved by the Ethics Committee Research UZ/KU Leuven (internal study number S67204). Results will be published in peer-reviewed journals and presented at (inter)national scientific meetings.Trial registration number NCT06042803. |
| first_indexed | 2024-04-24T11:24:28Z |
| format | Article |
| id | doaj.art-5487581855704e0c8a5088a69a4388c6 |
| institution | Directory Open Access Journal |
| issn | 2399-9772 |
| language | English |
| last_indexed | 2024-04-24T11:24:28Z |
| publishDate | 2024-04-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Paediatrics Open |
| spelling | doaj.art-5487581855704e0c8a5088a69a4388c62024-04-10T20:45:10ZengBMJ Publishing GroupBMJ Paediatrics Open2399-97722024-04-018110.1136/bmjpo-2023-002385Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION projectKarel Allegaert0Anne Smits1Kristel Van Calsteren2Pieter Annaert3An Eerdekens4Martje Van Neste5Nina Nauwelaerts6Michael Ceulemans74 Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium2 L-C&Y, KU Leuven Child & Youth Institute, Leuven, BelgiumGynaecologic oncology, Leuven Cancer Institute (LKI), UZ Gasthuisberg, Katholieke Universiteit Leuven, Belgium;3Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Belgium7 Neonatal Intensive Care Unit, University Hospitals Leuven, Leuven, Belgium1 Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium3 Drug Delivery and Disposition, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium1 Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, BelgiumIntroduction Breastfeeding is beneficial for the health of the mother and child. However, at least 50% of postpartum women need pharmacotherapy, and this number is rising due to the increasing prevalence of chronic diseases and pregnancies at a later age. Making informed decisions on medicine use while breastfeeding is often challenging, considering the extensive information gap on medicine exposure and safety during lactation. This can result in the unnecessary cessation of breastfeeding, the avoidance of pharmacotherapy or the off-label use of medicines. The UmbrelLACT study aims to collect data on human milk transfer of maternal medicines, child exposure and general health outcomes. Additionally, the predictive performance of lactation and paediatric physiologically based pharmacokinetic (PBPK) models, a promising tool to predict medicine exposure in special populations, will be evaluated.Methods and analysis Each year, we expect to recruit 5–15 breastfeeding mothers using pharmacotherapy via the University Hospitals Leuven, the BELpREG project (pregnancy registry in Belgium) or external health facilities. Each request and compound will be evaluated on relevance (ie, added value to available scientific evidence) and feasibility (including access to analytical assays). Participants will be requested to complete at least one questionnaire on maternal and child’s general health and collect human milk samples over 24 hours. Optionally, two maternal and one child’s blood samples can be collected. The maternal medicine concentration in human milk will be determined along with the estimation of the medicine intake (eg, daily infant dose and relative infant dose) and systemic exposure of the breastfed child. The predictive performance of PBPK models will be assessed by comparing the observed concentrations in human milk and plasma to the PBPK predictions.Ethics and dissemination This study has been approved by the Ethics Committee Research UZ/KU Leuven (internal study number S67204). Results will be published in peer-reviewed journals and presented at (inter)national scientific meetings.Trial registration number NCT06042803.https://bmjpaedsopen.bmj.com/content/8/1/e002385.full |
| spellingShingle | Karel Allegaert Anne Smits Kristel Van Calsteren Pieter Annaert An Eerdekens Martje Van Neste Nina Nauwelaerts Michael Ceulemans Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project BMJ Paediatrics Open |
| title | Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project |
| title_full | Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project |
| title_fullStr | Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project |
| title_full_unstemmed | Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project |
| title_short | Determining the exposure of maternal medicines through breastfeeding: the UmbrelLACT study protocol—a contribution from the ConcePTION project |
| title_sort | determining the exposure of maternal medicines through breastfeeding the umbrellact study protocol a contribution from the conception project |
| url | https://bmjpaedsopen.bmj.com/content/8/1/e002385.full |
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