PrematurityNEO-CHOLINNCT02027584
Observational Study of Choline, Its Metabolites, and Phospholipids in Preterm Infants
An observational study of Prematurity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
To study concentrations of choline, its metabolites, and phospholipids in cord blood and remnants of clinically indicated blood samples Read more about this study
- Who is it for?
- Ages Up to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- collection of remnant of clinically indicated blood sample
- How many people
- 414 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2008to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: term and preterm neonates, parturients, non-pregnant females
Who may be able to join
- meeting criteria of the 4 cohorts
Who cannot join
- none pre-defined
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supply of Term and Preterm Neonates With Choline, Lipids and Vitamines
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.
- Conditions
- Prematurity
- Being tested
- collection of remnant of clinically indicated blood sample
- Keywords
- infant, premature, infant, newborn, choline
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of remnant of clinically indicated blood sampleOther
collection of remnant of clinically indicated blood sample
| Study group | Role | What they receive |
|---|---|---|
| parturient | mother who had given birth within 48 hours of clinically indicated blood sampling Receives: Other: collection of remnant of clinically indicated blood sample | |
| healthy, non-pregnant, female volunteers | healthy, non-pregnant, female volunteers Receives: Other: collection of remnant of clinically indicated blood sample | |
| preterm infant | gestational age at birth < 37 weeks Receives: Other: collection of remnant of clinically indicated blood sample | |
| term infant | gestational age at birth >36 weeks Receives: Other: collection of remnant of clinically indicated blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of choline in plasma
Measured: 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
Measured: 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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startNov 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Tübingen
- Responsible party
- Sponsor
- Investigators
- Wolfgang Bernhard, MD, PhD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027584
- Sponsor's protocol ID
- NEO-CHOLIN
- Acronym
- NEO-CHOLIN
- Status last verified
- Dec 2013
- First submitted
- 20 Dec 2013
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
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 22961562Bernhard 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supply of Term and Preterm Neonates With Choline, Lipids and Vitamines
- ClinicalTrials.gov ID
- NCT02027584
- Acronym / sponsor ID
- NEO-CHOLIN / NEO-CHOLIN
- Conditions
- Prematurity
- Keywords
- infant, premature, infant, newborn, choline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Universität Tübingen
- Study start
- Nov 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study concentrations of choline, its metabolites, and phospholipids in cord blood and remnants of clinically indicated blood samples
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| parturient | – | Other: collection of remnant of clinically indicated blood samplemother who had given birth within 48 hours of clinically indicated blood sampling |
| healthy, non-pregnant, female volunteers | – | Other: collection of remnant of clinically indicated blood samplehealthy, non-pregnant, female volunteers |
| preterm infant | – | Other: collection of remnant of clinically indicated blood samplegestational age at birth < 37 weeks |
| term infant | – | Other: collection of remnant of clinically indicated blood samplegestational age at birth >36 weeks |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- term and preterm neonates, parturients, non-pregnant females
Key inclusion criteria (1 listed)
- meeting criteria of the 4 cohorts
Key exclusion criteria (1 listed)
- none pre-defined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of remnant of clinically indicated blood samplecollection of remnant of clinically indicated blood sample | Other | healthy, non-pregnant, female volunteers, parturient, preterm infant, term infant |
Primary outcome
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)
2 secondary outcomes
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2014.
- Background: PubMed 22961562Bernhard 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.
- Derived from this study: PubMed 25148882Bernhard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Bernhard, MD, PhD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02027584, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2014.