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CompletedNCT02027584NEO-CHOLINUpdated Jan 6, 2014

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

An observational study in Prematurity, sponsored by University Hospital Tuebingen. Completed at 1 site in Germany. Open to participants aged Up to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-06.

Sponsored by University Hospital Tuebingen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
414
Ages
Up to 6 Months
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Prematurity

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Keywords

  • infant, premature
  • infant, newborn
  • choline
03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 414 is above the median of 112 across 777 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University Hospital Tuebingen is the lead sponsor of 476 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 6 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

term and preterm neonates, parturients, non-pregnant females

Inclusion criteria

  • meeting criteria of the 4 cohorts

Exclusion criteria

Exclusion Criteria:

  • none pre-defined
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
414 participants (actual)
Patient registry
No

Groups and cohorts

  • parturient

    mother who had given birth within 48 hours of clinically indicated blood sampling

    Other: collection of remnant of clinically indicated blood sample

  • healthy, non-pregnant, female volunteers

    healthy, non-pregnant, female volunteers

    Other: 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

  • term infant

    gestational age at birth \>36 weeks

    Other: collection of remnant of clinically indicated blood sample

Interventions

  • Othercollection of remnant of clinically indicated blood sample

    collection of remnant of clinically indicated blood sample

06

What researchers measure

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

07

Study locations

1 site
  • University Hospital Tuebingen
    Tuebingen, 72076, Germany
08

References and documents

Publications

  • Bernhard W, Full A, Arand J, Maas C, Poets CF, Franz AR. Choline supply of preterm infants: assessment of dietary intake and pathophysiological considerations. Eur J Nutr. 2013 Apr;52(3):1269-78. doi: 10.1007/s00394-012-0438-x. Epub 2012 Sep 9. PubMed 22961562 ↗
  • Bernhard W, Raith M, Kunze R, Koch V, Heni M, Maas C, Abele H, Poets CF, Franz AR. Choline concentrations are lower in postnatal plasma of preterm infants than in cord plasma. Eur J Nutr. 2015 Aug;54(5):733-41. doi: 10.1007/s00394-014-0751-7. Epub 2014 Aug 23. PubMed 25148882 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02027584
Lead sponsor
University Hospital Tuebingen
Collaborators
Universität Tübingen
Responsible party
Sponsor
First posted
Jan 6, 2014
Start date
Nov 2008
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jan 6, 2014

Study contacts

Wolfgang Bernhard, MD, PhD
principal investigator · University Hospital Tuebingen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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