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Transfer of prednisolone into human breast milk and plasma of breastfeeding children - A low intervention cohort study with biobanking of breast milk and plasma

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508913-18-00
Enrollment
30
Registered
2024-03-05
Start date
2024-03-05
Completion date
2025-12-31
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatory bowel disease, myositis, psoriatric arthritis, Reumatoid Arthritis, SLE

Brief summary

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.

Detailed description

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., Concentration of cortisol in the infant blood at same timepoint blood is drawn for PK measurement.

Interventions

DRUGPREDNISOLONE

Sponsors

Uppsala Universitet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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., Concentration of cortisol in the infant blood at same timepoint blood is drawn for PK measurement.

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026