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Идёт набор NCT07346716

Medicines in Breast Milk and Estimated Infant Exposure

— Наблюдательное Breastfeeding Medication Safety Lactation Drug Exposure Via Breast Milk

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Prescription Drugs.
Кому может быть актуально
Состояния в реестре: Breastfeeding, Medication Safety, Lactation, Drug Exposure Via Breast Milk. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Дания
Следующий шаг
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Официальное название

Medication Concentrations in Human Milk (MedMilk) and Potential Adverse Effects in Breastfed Infants: an Exploratory Clinical Study

Обзор

The MedMilk (Medication concentrations in human Milk) study investigates how selected medicines taken by breastfeeding women are transferred into human milk and whether this may affect the breastfed child. The study includes breastfeeding women who are already using prescription or over-the-counter medicines as part of their usual care. Participants provide samples of breast milk and urine and complete a questionnaire about maternal and infant health. The collected data will be used to quantify medicine concentrations in milk and estimate the relative infant dose. The study aims to contribute new data to support safer prescribing and more informed counselling during breastfeeding

Подробное описание

The MedMilk (Medication concentrations in human Milk) study is a prospective, exploratory clinical study coordinated by the Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, Denmark. The study is observational in nature and involves no experimental drug administration. Participants are breastfeeding women using medicines as part of their routine treatment.

Each participant will provide four small breast milk samples (1-20 mL each) collected at different time points in relation to maternal drug intake, one urine sample, and questionnaire data on maternal and infant health, breastfeeding patterns, and any infant symptoms potentially related to drug exposure. Samples are stored at -80 °C in a dedicated research biobank until analysis.

Drug concentrations in milk and urine will primarily be quantified using solid Phase Extraction coupled with UPLC-MS/MS. Data will be analyzed descriptively, and relative infant doses (RID) will be calculated. For drugs with sufficient sampling density.

Results will add to the limited body of systematic data on drug transfer into human milk and help inform clinical decision-making regarding medication use during breastfeeding.

Вмешательства

  • Препарат Prescription Drugs
    Exposure to prescription medicines taken by breastfeeding women during routine treatment. The study does not assign medications but observes drug transfer into human milk from exposures occurring as part of usual care.

Первичные конечные точки

  • Drug concentrations in human milk [Срок оценки: Within one dosing interval]
Вторичные конечные точки (2)
  • Relative Infant Dose (RID) [Срок оценки: Within one dosing interval]
  • Maternal-reported infant adverse effects [Срок оценки: At the time of inclusion. Montly follow-up for three months.]

Критерии участия

Критерии включения

  • Lactating women aged ≥18 years
  • Current use of one or more prescription or over-the-counter (classified within the ATC system) drugs
  • Able and willing to provide written informed consent

Критерии исключения

  • Current pregnancy during sample collection
  • Known and clinically significant pharmacokinetic drug-drug interactions at the time of sampling

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Дания · 3 центра
  • Department of Clinical Pharmacology — Copenhagen
  • Mental health services, Capital Region of Denmark — Copenhagen
  • Department of Obstetrics and Gynecology, Herlev Hospital — Herlev

Публикации

  • Resendal Gotfredsen D, Heerfordt IM, Kahler Byskov P, Horwitz H, Gade C, Loekkegaard E, Friis-Hansen L, Bach Nielsen Fruekilde P, Cvetanovska E, Joergensen NR, Pedersen LH, Andersen JT. Medication concentrations in human milk and potential adverse effects in breastfed infants (MedMilk): a protocol for an observational clinical study. BMJ Open. 2026 May 29;16(5):e119958. doi: 10.1136/bmjopen-2026-1 PMID 42215272

Идентификаторы

NCT: NCT07346716 · H-23062687

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗