Breast Feeding, Exclusive Clinical Trial
— CONCEPTIONOfficial title:
Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach.
Verified date | August 2023 |
Source | University Hospital, Toulouse |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Based on plasma and milk concentrations, a PopPK model will be performed (i) to document the average and individual exposure to amoxicillin in milk, (ii) to identify the factors explaining the inter-individual pharmacokinetic variability and (iii) to determine the daily dose ingested by the infant and its variability for different dosage regimens applied to the mother. The secondary objectives are to monitor (i) predefined adverse reactions in infants and (ii) the impact on milk production.
Status | Completed |
Enrollment | 25 |
Est. completion date | July 12, 2023 |
Est. primary completion date | July 12, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Mothers over 18 years, treated by amoxicillin for at least 2 days who breastfeed their child, - Participation requires that breastfeeding is already well established (i.e., at least 2 weeks after giving birth in order to sample mature milk) and that the infant is over 4 weeks old, - Affiliation to the social security scheme or equivalent, - Ability to understand and willingness to sign a written Informed Consent document. Exclusion Criteria: - Mothers under 18 years old, - Infants born prematurely (i.e., gestational age under 34 weeks) or requiring appropriate medical supervision or support from a team of social workers, - Mothers who gave birth to twins, - Inability to communicate due to language problems for the mother, - Patient subject to a legal protection order (curatorship or tutorship). |
Country | Name | City | State |
---|---|---|---|
France | APHP Hôpital Necker, Lactarium Régional d'Ile de France | Paris | |
France | CHU Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration-time profile of amoxicillin in milk | At the time of samplings (day 0) | ||
Primary | Concentration-time profile of amoxicillin in plasma | At the time of samplings (day 0) | ||
Secondary | Occurrence of predefined side effects in infants during the breastfeeding period. | Occurrence of diarrhoea, nausea, vomiting, feeding difficulties, skin rashes, urticaria and candidiasis will be monitored using a form on the infant's health status and breastmilk production will be completed by the mother/parent at the time of samplings and a week later. | At the time of samplings (day 0) and a week later (day 7) | |
Secondary | Impact of mother's drug consumption on breast milk production. | A form on breastmilk production will be completed by the mother/parent at the time of samplings and a week later | At the time of samplings (day 0) and a week later (day 7) |
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