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

NCT ID: NCT02027584

Last Updated: 2014-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

414 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Prematurity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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parturient

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

collection of remnant of clinically indicated blood sample

Intervention Type OTHER

collection of remnant of clinically indicated blood sample

healthy, non-pregnant, female volunteers

healthy, non-pregnant, female volunteers

collection of remnant of clinically indicated blood sample

Intervention Type OTHER

collection of remnant of clinically indicated blood sample

preterm infant

gestational age at birth \< 37 weeks

collection of remnant of clinically indicated blood sample

Intervention Type OTHER

collection of remnant of clinically indicated blood sample

term infant

gestational age at birth \>36 weeks

collection of remnant of clinically indicated blood sample

Intervention Type OTHER

collection of remnant of clinically indicated blood sample

Interventions

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collection of remnant of clinically indicated blood sample

collection of remnant of clinically indicated blood sample

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* meeting criteria of the 4 cohorts

Exclusion Criteria

* none pre-defined
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universität Tübingen

OTHER

Sponsor Role collaborator

University Hospital Tuebingen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfgang Bernhard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tuebingen

Locations

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University Hospital Tuebingen

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type BACKGROUND
PMID: 22961562 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25148882 (View on PubMed)

Other Identifiers

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NEO-CHOLIN

Identifier Type: -

Identifier Source: org_study_id

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