Increase and decrease of the concentration of choline derivates in the plasma of preterm infants after the administration of unlabeled choline supplements

Not Applicable

• Conditions: E63.8; Other specified nutritional deficiencies

• Registration Number: DRKS00020505
• Lead Sponsor: niversitätsklinikum Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Gestational age at birth 28-32 weeks
2. full enteral feeding
3. no acute diseases

Exclusion Criteria

1. Growth retardation / birth weight < 3rd percentile
2. genetic diseases
3. Diseases, that change the lipid metabolism, especially the gastro intestinum (i.e. stoma, exocrine pancreas insufficience, cholestase), systemic glucocorticoidtherapy, kidney insufficience (creatinine >1.5mg/dl), ventricular funcitonal limitations that influence the liver function
4. no informed consent of both parents

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC of the choline plasma concentration 0h-54h

Secondary Outcome Measures

Name	Time	Method
1. Change of plasma concentration of cholin between 3 and 54h<br>2. Change of plasma concentrations of metabolites between 3 and 54h