Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000059

EU PAS number

EUPAS1000000059

Study ID

1000000059

Official title and acronym

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

DARWIN EU® study

No

Study countries

Sweden

Study description

The project has a low intervention trials design in the sense that breast milk and blood will be collected merely to study excretion of prednisolon into breastmilk and transferal to her child. Participation in the study will not decide or in any other way interfere with patients' treatment as prescribed by their physician. Only patients that already have been assigned treatment with prednisolon by their physician will be approached and asked for participation.
Samples will be analysed for pharmacokinetic properties using mass spectrometry at the UDOPP Platform (Uppsala Drug Optimization and Pharmaceutical Profiling) at the Department of Pharmacy, Uppsala University.
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 objectives are 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). A tertiary objective is to evaluate the cortisol levels in the infants.
The primary endpoint is the concentration of prednisolone in the breastfeeding child’s plasma 2h after feeding an infant breast milk, with the feeding taking place at 1h following maternal dose intake. The secondary endpoints are the 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. The tertiary endpoint is the concentration of cortisol in the infant blood.
The quantification of prednisolone concentrations in human milk and maternal and infant plasma will be made using LC-MS/MS bioanalytical method in accordance with a standard operating procedure.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Mats Hansson

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EU institutional research programme

More details on funding

ConcePTION IMI-JU 2: 821520
Study protocol
Updated protocol

Clinical trial protocol - Prednisolone redacted (2).PDF

English (172.14 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable