Transfer of prednisolone into human breast milk and plasma of breastfeeding childre
Phase 1
Recruiting
- Conditions
- Reumatoid Arthritis, SLE, myositis, psoriatric arthritis, inflammatory bowel diseaseTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- CTIS2023-508913-18-00
- Lead Sponsor
- ppsala Universitet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Breastfeeding women treated with prednisolone with doses up to 50mg/day for any condition and her child., Only women of 18 years of age and older will be asked for participation., Signed Informed consent form from the woman that participates in the study and the father of the child.
Exclusion Criteria
Woman not able to read and communicate in Swedish or English., Women with infant born prior to 37 weeks gestation (premature)., Women with multiple births.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to determine the concentration of prednisolone in the plasma of breast-fed infants of lactating women treated with prednisolone to reduce inflammation in a variety of conditions.;Secondary Objective: To determine concentration of prednisolone/prednisone in the breast milk and maternal plasma and the milk-to-plasma ratio in the mothers and to calculate the average daily infant dose (ADID) and relative infant dose (RID). to evaluate the cortisol levels in the infants., To evaluate the cortisol levels in the infants.;Primary end point(s): The primary endpoint is the concentration of prednisolone in the breastfeeding child’s plasma 2 hr after feeding an infant breast milk, with the feeding taking place at 1 hr following maternal dose intake.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Concentration of prednisolone and prednisone in breast milk at 1h after maternal dose intake and the maternal plasma concentration of prednisolone and prednisone at 1h after prednisolone intake.;Secondary end point(s):Concentration of cortisol in the infant blood at same timepoint blood is drawn for PK measurement.