Observational Study of Choline, Its Metabolites, and Phospholipids in Preterm Infants

Completed

• Conditions: Prematurity
• Interventions: Other: collection of remnant of clinically indicated blood sample

• Registration Number: NCT02027584
• Lead Sponsor: University Hospital Tuebingen

Brief Summary

To study concentrations of choline, its metabolites, and phospholipids in cord blood and remnants of clinically indicated blood samples

Detailed Description

To collect cord plasma in preterm and term infants. To collect remnants of clinically indicated blood samples in parturients and hospitalized preterm infants during neonatal intensive care.

To determine concentrations of choline, its metabolites, and phospholipids by mass spectrometry.

To compare cord plasma concentrations with postnatal plasma concentrations.

Study Timeline

• Study Start: 2008-11
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-12
• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2014-01-02
• Last Update Submitted: 2014-01-02
• Study First Posted: 2014-01-06
• Last Update Posted: 2014-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 414

Inclusion Criteria

• meeting criteria of the 4 cohorts

Exclusion Criteria

• none pre-defined

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
parturient	collection of remnant of clinically indicated blood sample	mother who had given birth within 48 hours of clinically indicated blood sampling
preterm infant	collection of remnant of clinically indicated blood sample	gestational age at birth \< 37 weeks
term infant	collection of remnant of clinically indicated blood sample	gestational age at birth \>36 weeks
healthy, non-pregnant, female volunteers	collection of remnant of clinically indicated blood sample	healthy, non-pregnant, female volunteers

Primary Outcome Measures

Name	Time	Method
Concentration of choline in plasma	at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants)

Secondary Outcome Measures

Name	Time	Method
Concentrations of molecular species of phosphatidylcholine and phosphatidylethanolamine	at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants)
concentrations of choline metabolites	at times when a clinically indicated blood sample is taken before discharge home from the initial neonatal hospitalization (at a postnatal age of up to 4-5 months at the most in very preterm infants)

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany