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OpenTrials
Completed

NCT Number: NCT02027584

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

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

Completed

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Key information

Conditions

Prematurity Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Tuebingen

Tübingen, 72076, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • meeting criteria of the 4 cohorts

Exclusion criteria

  • none pre-defined

Treatment and study plan

collection of remnant of clinically indicated blood sample

Other

collection of remnant of clinically indicated blood sample

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)

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Collaborators

  • Universität Tübingen

Registry information

Official study title

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

Acronym: NEO-CHOLIN

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jan 6, 2014
Registry last updated
Jan 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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