Observational Study of Choline, Its Metabolites, and Phospholipids in Preterm Infants (NEO-CHOLIN)

January 2, 2014 updated by: University Hospital Tuebingen

Supply of Term and Preterm Neonates With Choline, Lipids and Vitamines

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

414

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tuebingen, Germany, 72076
        • University Hospital Tuebingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

term and preterm neonates, parturients, non-pregnant females

Description

Inclusion Criteria:

  • meeting criteria of the 4 cohorts

Exclusion Criteria:

  • none pre-defined

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concentration of choline in plasma
Time Frame: 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)
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

Outcome Measure
Time Frame
concentrations of choline metabolites
Time Frame: 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)
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 molecular species of phosphatidylcholine and phosphatidylethanolamine
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Universität Tübingen

Investigators

  • Principal Investigator: Wolfgang Bernhard, MD, PhD, University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 20, 2013

First Submitted That Met QC Criteria

January 2, 2014

First Posted (Estimate)

January 6, 2014

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEO-CHOLIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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