Clinical trial NCT03785990: Fatty Acid Composition of Subcutaneous Adipose Tissue in Infants: A Prospective and Observational 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prematurity
Subcutaneous Adipose Tissue
Keywords: preterm
fatty acid
docosahexaenoic acid
arachidonic acid
infant
adipose tissue
subcutaneous adipose tissue
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 21
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: term and preterm neonates

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* meeting criteria of the 3 cohorts

Exclusion Criteria:

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

Primary outcomes:
measure: Fatty acid composition of the subcutaneous adipose tissue and plasma
timeFrame: at the time of the operation
Secondary outcomes:
measure: Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems
timeFrame: 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)
measure: Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems and preterms without abdominal problems at term
timeFrame: 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)
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital of Tuebingen
Study officials:
affiliation: University Hospital Tuebingen
name: Axel Franz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.