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

NCT02027584 | Completed

• 1 other identifier: NEO-CHOLIN
• Study Type: observational
• Target: 414
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prematurity

Keywords

infant, premature; infant, newborn; choline

Outcome Measures

Primary Outcomes (1)

• Concentration of choline in plasma

  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 (2)

• concentrations of choline metabolites

  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

  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)

Study Arms (4)

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

collection of remnant of clinically indicated blood sample OTHER

collection of remnant of clinically indicated blood sample

healthy, non-pregnant, female volunteers; parturient; preterm infant; term infant

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

term and preterm neonates, parturients, non-pregnant females

You may qualify if:

• meeting criteria of the 4 cohorts

You may not qualify if:

• none pre-defined

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Universität Tübingen: collaborator

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (2)

• 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.

  PMID: 22961562 BACKGROUND

• 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.

  PMID: 25148882 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Wolfgang Bernhard, MD, PhD

  University Hospital Tuebingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: January 6, 2014
• Study Start: November 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 6, 2014

Record last verified: 2013-12

Locations

DE (1)