PrematurityNCT03785990
Fatty Acid Composition of Subcutaneous Adipose Tissue in Infants: A Prospective and Observational Study
An observational study of Prematurity and Subcutaneous Adipose Tissue, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The fatty acid composition in blood and subcutaneous adipose tissue of infants that have an clinical indicated operation is studied. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Prematurity, Subcutaneous Adipose Tissue
- What is being tested?
- adipose tissue, blood and PEAPOD
- Type of treatment
- Injection or infusion
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 3 Apr 2017to 31 Oct 2019
- 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
- No healthy volunteers
- Child
Study population: term and preterm neonates
Who may be able to join
- meeting criteria of the 3 cohorts
Who cannot join
- metabolic diseases of the infant
- genetic diseases
- missing agreement for the study
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Tuebingen
Tübingen, 72076
Axel R Franz, MD, +49707129-0 ext. 82211, axel.franz@med.uni-tuebingen.de
Axel R Franz, MD
About this study
Official title: Untersuchung Intraoperativ Entnommener Subkutaner Fettgewebeproben Früh- Und Reifgeborener Auf Die Fettsäure-Zusammensetzung Der Triglyceride Und Der Phospholipide Mit Speziellem Fokus Auf Die Mehrfach ungesättigten Fettsäuren Docosahexaensäure Und Arachidonsäure Wissenschaftliche Untersuchung Bei Minderjährigen
The fatty acid composition in blood and subcutaneous adipose tissue of infants that have an clinical indicated operation is studied.
Read the detailed description
Collection of:
- subcutaneous adipose tissue of term infants and preterms after birth and at term during a clinically indicated operation.
- blood before the operation.
Measurement of the fatty acid composition (especially arachidonic acid and docosahexaenoic acid) in subcutaneous adipose tissue and blood.
Aim is to compare the composition of the fatty acids in blood and adipose tissue of preterms at term and term infants. To calculate the fatty acid value in each infant the proportion of adipose tissue is determined with PEAPOD before discharge from hospital.
- Conditions
- Prematurity, Subcutaneous Adipose Tissue
- Being tested
- adipose tissue, blood, PEAPOD
- Keywords
- preterm, fatty acid, docosahexaenoic acid, arachidonic acid, infant, adipose tissue, subcutaneous adipose tissue
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adipose tissueOther
taking a sample of the adipose tissue during operation
bloodOther
taking a blood sample when a peripheral venous catheter is inserted before operation
PEAPODDiagnostic test
Measurement of the total adipose tissue of the infant with PEAPOD (Air Displacement-Plethysmography, Infant Body Composition System, Cosmed, Rome, Italy)
| Study group | Role | What they receive |
|---|---|---|
| preterms with enterostomy | GA 23±0/7 - 31±6/7 with clinically indicated operations because of NEC (necrotising enterocolitis) or FIP (focal intestinal perforation). Operation after birth (within 14 days) and at term (enterostomy closure) Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD) Receives: Other: adipose tissue; Other: blood; Diagnostic Test: PEAPOD | |
| preterms without enterostomy | GA 23±0/7 bis 31±6/7 with a clinically indicated operation (e.g. herniotomy) at term, without any abdominal problems.
Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD) Receives: Other: adipose tissue; Other: blood; Diagnostic Test: PEAPOD | |
| term infants | GA ≥34±0/7 with a clinically indicated operation directly after birth (within 14 days) (e.g. gastroschisis).
Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD) Receives: Other: adipose tissue; Other: blood; Diagnostic Test: PEAPOD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty acid composition of the subcutaneous adipose tissue and plasma
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms at term compared to the composition of infants after birth (within 14 days).
Measured: at the time of the operation
Secondary outcomes (2)
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems
Change of fatty acid composition of the subcutaneous tissue and plasma from first to second operation in preterms with abdominal operations, enterostomy
Measured: time of the first operation until discharge home (at a postnatal age of up to 4-5 months at the most in very preterm infants)
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems and preterms without abdominal problems at term
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms at term compared to the composition of preterms at term with enterostomy.
Measured: time of the first operation until discharge home (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 posted24 Dec 2018
- Study start3 Apr 2017
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- 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
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Axel Franz, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785990
- Sponsor's protocol ID
- NEO-Adipose tissue
- Status last verified
- May 2018
- First submitted
- 9 May 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bockmann KA, von Stumpff A, Bernhard W, Shunova A, Minarski M, Frische B, Warmann S, Schleicher E, Poets CF, Franz AR. Fatty acid composition of adipose tissue at term indicates deficiency of arachidonic and docosahexaenoic acid and excessive linoleic acid supply in preterm infants. Eur J Nutr. 2021 Mar;60(2):861-872. doi: 10.1007/s00394-020-02293-2. Epub 2020 May 31.
PubMed 32476053
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Untersuchung Intraoperativ Entnommener Subkutaner Fettgewebeproben Früh- Und Reifgeborener Auf Die Fettsäure-Zusammensetzung Der Triglyceride Und Der Phospholipide Mit Speziellem Fokus Auf Die Mehrfach ungesättigten Fettsäuren Docosahexaensäure Und Arachidonsäure Wissenschaftliche Untersuchung Bei Minderjährigen
- ClinicalTrials.gov ID
- NCT03785990
- Acronym / sponsor ID
- NEO-Adipose tissue
- Conditions
- Prematurity, Subcutaneous Adipose Tissue
- Keywords
- preterm, fatty acid, docosahexaenoic acid, arachidonic acid, infant, adipose tissue, subcutaneous adipose tissue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 24 Dec 2018 (actual)
- 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.
The fatty acid composition in blood and subcutaneous adipose tissue of infants that have an clinical indicated operation is studied.
Detailed description
Collection of:
- subcutaneous adipose tissue of term infants and preterms after birth and at term during a clinically indicated operation.
- blood before the operation.
Measurement of the fatty acid composition (especially arachidonic acid and docosahexaenoic acid) in subcutaneous adipose tissue and blood.
Aim is to compare the composition of the fatty acids in blood and adipose tissue of preterms at term and term infants. To calculate the fatty acid value in each infant the proportion of adipose tissue is determined with PEAPOD before discharge from hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| preterms with enterostomy | – | Other: adipose tissue, Other: blood, Diagnostic Test: PEAPODGA 23±0/7 - 31±6/7 with clinically indicated operations because of NEC (necrotising enterocolitis) or FIP (focal intestinal perforation). Operation after birth (within 14 days) and at term (enterostomy closure) Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD) |
| preterms without enterostomy | – | Other: adipose tissue, Other: blood, Diagnostic Test: PEAPODGA 23±0/7 bis 31±6/7 with a clinically indicated operation (e.g. herniotomy) at term, without any abdominal problems. Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD) |
| term infants | – | Other: adipose tissue, Other: blood, Diagnostic Test: PEAPODGA ≥34±0/7 with a clinically indicated operation directly after birth (within 14 days) (e.g. gastroschisis). Analysis of the blood, subcutaneous adipose tissue und total adipose tissue (PEAPOD) |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- term and preterm neonates
Key inclusion criteria (1 listed)
- meeting criteria of the 3 cohorts
Key exclusion criteria (3 listed)
- metabolic diseases of the infant
- genetic diseases
- missing agreement for the study
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 |
|---|---|---|
| adipose tissuetaking a sample of the adipose tissue during operation | Other | preterms with enterostomy, preterms without enterostomy, term infants |
| bloodtaking a blood sample when a peripheral venous catheter is inserted before operation | Other | preterms with enterostomy, preterms without enterostomy, term infants |
| PEAPODMeasurement of the total adipose tissue of the infant with PEAPOD (Air Displacement-Plethysmography, Infant Body Composition System, Cosmed, Rome, Italy) | Diagnostic test | preterms with enterostomy, preterms without enterostomy, term infants |
Primary outcome
Fatty acid composition of the subcutaneous adipose tissue and plasma
Time frame: at the time of the operation
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms at term compared to the composition of infants after birth (within 14 days).
2 secondary outcomes
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems
Time frame: time of the first operation until discharge home (at a postnatal age of up to 4-5 months at the most in very preterm infants)
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems and preterms without abdominal problems at term
Time frame: time of the first operation until discharge home (at a postnatal age of up to 4-5 months at the most in very preterm infants)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Derived from this study: PubMed 32476053Bockmann KA, von Stumpff A, Bernhard W, Shunova A, Minarski M, Frische B, Warmann S, Schleicher E, Poets CF, Franz AR. Fatty acid composition of adipose tissue at term indicates deficiency of arachidonic and docosahexaenoic acid and excessive linoleic acid supply in preterm infants. Eur J Nutr. 2021 Mar;60(2):861-872. doi: 10.1007/s00394-020-02293-2. Epub 2020 May 31.
- Individual participant dataSharing planned: No
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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.
Axel Franz 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 and Subcutaneous Adipose Tissue, 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 3 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: status not confirmed, as of the sponsor's last update on 24 Dec 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrin Böckmann (+49707129 ext. 82621, katrin.boeckmann@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatty acid composition of the subcutaneous adipose tissue and plasma (time frame: at the time of the operation). 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 NCT03785990, which also lists 1 linked publication.
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 24 Dec 2018.