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

Prematurity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03785990
• Other study ID #: NEO-Adipose tissue
• Status: Recruiting
• Start date: April 3, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: May 2018
• Source: University Hospital Tuebingen
• Contact: Katrin Böckmann
• Phone: +49707129
• Email: katrin.boeckmann[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The fatty acid composition in blood and subcutaneous adipose tissue of infants that have an clinical indicated operation is studied.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• meeting criteria of the 3 cohorts

Exclusion Criteria:

• metabolic diseases of the infant

• genetic diseases

• missing agreement for the study

Related Conditions & MeSH terms

• Prematurity
• Subcutaneous Adipose Tissue

Intervention

Other:
• adipose tissue
taking a sample of the adipose tissue during operation
• 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)

Locations

Country	Name	City	State
Germany	University Hospital of Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	at the time of the operation
Secondary	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	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)
Secondary	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.	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)