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

• Conditions: Prematurity; Subcutaneous Adipose Tissue
• Interventions: Other: adipose tissue; Other: blood; Diagnostic Test: PEAPOD

• Registration Number: NCT03785990
• Lead Sponsor: University Hospital Tuebingen

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.

Study Timeline

• Study Start: 2017-04-03
• Status Verified: 2018-05
• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-12-21
• Last Update Submitted: 2018-12-21
• Study First Posted: 2018-12-24
• Last Update Posted: 2018-12-24
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• meeting criteria of the 3 cohorts

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
preterms with enterostomy	adipose tissue	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)
preterms without enterostomy	adipose tissue	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)
term infants	PEAPOD	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)
preterms with enterostomy	PEAPOD	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)
preterms without enterostomy	PEAPOD	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)
preterms with enterostomy	blood	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)
preterms without enterostomy	blood	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)
term infants	adipose tissue	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)
term infants	blood	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)

Primary Outcome Measures

Name	Time	Method
Fatty acid composition of the subcutaneous adipose tissue and plasma	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).

Secondary Outcome Measures

Name	Time	Method
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems	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
Fatty acid composition of the subcutaneous adipose tissue and plasma of preterms with abdominal problems and preterms without abdominal problems at term	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.

Trial Locations

Locations (1)

University Hospital of Tuebingen; 🇩🇪 Tuebingen, Germany