Medication concentrations in human milk and potential adverse effects in breastfed infants (MedMilk): a protocol for an observational clinical study
Abstract
Introduction: Data on medication concentrations in human milk and their potential effects on the breastfed infant remain limited, leaving clinicians with insufficient evidence to guide women who require medication while breastfeeding. The MedMilk study aims to systematically measure medication concentrations in human milk, calculate the relative infant dose (RID) and evaluate infant outcomes.
Methods and analysis: This observational clinical study will recruit breastfeeding women using prescription and over-the-counter medications. Women will provide milk and urine samples along with self-reported maternal and infant health data. The primary outcome is quantification of medication concentrations in human milk. Secondary outcomes include estimation of the RID based on measured milk concentrations, maternally reported infant symptoms and adverse events potentially related to medication exposure, and pharmacokinetically simulated infant plasma exposure. Analytical methods include solid-phase extraction liquid chromatography-tandem mass spectrometry for quantification combined with descriptive statistics and pharmacokinetic modelling. The study aims to recruit approximately 250 women across medication groups. For the most frequently used medications, we aim to include 20 participants per medication, with each participant contributing four milk samples and a urine sample. Biological samples will be stored in a biobank, and data in a secure database.
Ethics and dissemination: The…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 250 participants or records.
Read the paper
Related studies
- Effect of dexamethasone as an analgesic adjuvant to multimodal pain treatment after total knee arthroplasty: randomised clinical trial
- Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial
- Comparison of the Post-Caesarean Analgesic Effect of Adding Dexmedetomidine to Paracetamol and Ketorolac: A Randomized Clinical Trial
- A triple-blind randomized clinical trial of different associations between dexamethasone and non-steroids anti-inflammatories for preemptive action in third molar extractions
- An open label randomized clinical trial of Indomethacin for mild and moderate hospitalised Covid-19 patients
- Oral paracetamol and/or ibuprofen for treating pain after soft tissue injuries: Single centre double-blind, randomised controlled clinical trial
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.