Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02027584
Recruitment Status : Completed
First Posted : January 6, 2014
Last Update Posted : January 6, 2014
Sponsor:
Collaborator:
Universität Tübingen
Information provided by (Responsible Party):
University Hospital Tuebingen

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

Condition or disease Intervention/treatment
Prematurity Other: collection of remnant of clinically indicated blood sample

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 414 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Supply of Term and Preterm Neonates With Choline, Lipids and Vitamines
Study Start Date : November 2008
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

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
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




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
term and preterm neonates, parturients, non-pregnant females
Criteria

Inclusion Criteria:

  • meeting criteria of the 4 cohorts

Exclusion Criteria:

  • none pre-defined

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027584


Locations
Layout table for location information
Germany
University Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Universität Tübingen
Investigators
Layout table for investigator information
Principal Investigator: Wolfgang Bernhard, MD, PhD University Hospital Tuebingen
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT02027584    
Other Study ID Numbers: NEO-CHOLIN
First Posted: January 6, 2014    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: December 2013
Keywords provided by University Hospital Tuebingen:
infant, premature
infant, newborn
choline
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications