Fatty Acid Composition of Subcutaneous Adipose Tissue in Infants: A Prospective and Observational Study

December 21, 2018 updated by: University Hospital Tuebingen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

term and preterm neonates

Description

Inclusion Criteria:

  • meeting criteria of the 3 cohorts

Exclusion Criteria:

  • metabolic diseases of the infant
  • genetic diseases
  • missing agreement for the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Other: adipose tissue
taking a sample of the adipose tissue during operation
Other: blood
taking a blood sample when a peripheral venous catheter is inserted before operation
Diagnostic test: PEAPOD
Measurement of the total adipose tissue of the infant with PEAPOD (Air Displacement-Plethysmography, Infant Body Composition System, Cosmed, Rome, Italy)
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)
Other: adipose tissue
taking a sample of the adipose tissue during operation
Other: blood
taking a blood sample when a peripheral venous catheter is inserted before operation
Diagnostic test: PEAPOD
Measurement of the total adipose tissue of the infant with PEAPOD (Air Displacement-Plethysmography, Infant Body Composition System, Cosmed, Rome, Italy)
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)
Other: adipose tissue
taking a sample of the adipose tissue during operation
Other: blood
taking a blood sample when a peripheral venous catheter is inserted before operation
Diagnostic test: PEAPOD
Measurement of the total adipose tissue of the infant with PEAPOD (Air Displacement-Plethysmography, Infant Body Composition System, Cosmed, Rome, Italy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
at the time of the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change of fatty acid composition of the subcutaneous tissue and plasma from first to second operation in preterms with abdominal operations, enterostomy
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)
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms at term compared to the composition of preterms at term with enterostomy.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 3, 2017

Primary Completion (ANTICIPATED)

October 31, 2019

Study Completion (ANTICIPATED)

October 31, 2019

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

December 21, 2018

First Posted (ACTUAL)

December 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 24, 2018

Last Update Submitted That Met QC Criteria

December 21, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEO-Adipose tissue

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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