NCT03785990

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
Last Updated

December 24, 2018

Status Verified

May 1, 2018

Enrollment Period

2.6 years

First QC Date

May 9, 2018

Last Update Submit

December 21, 2018

Conditions

PrematuritySubcutaneous Adipose Tissue

Keywords

pretermfatty aciddocosahexaenoic acidarachidonic acidinfantadipose tissuesubcutaneous adipose tissue

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)

  • 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)

Study Arms (3)

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 tissueOther: bloodDiagnostic 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)

Other: adipose tissueOther: bloodDiagnostic 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)

Other: adipose tissueOther: bloodDiagnostic Test: PEAPOD

Interventions

adipose tissueOTHER

taking a sample of the adipose tissue during operation

preterms with enterostomypreterms without enterostomyterm infants
bloodOTHER

taking a blood sample when a peripheral venous catheter is inserted before operation

preterms with enterostomypreterms without enterostomyterm infants
PEAPODDIAGNOSTIC_TEST

Measurement of the total adipose tissue of the infant with PEAPOD (Air Displacement-Plethysmography, Infant Body Composition System, Cosmed, Rome, Italy)

preterms with enterostomypreterms without enterostomyterm infants

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

term and preterm neonates

You may qualify if:

  • meeting criteria of the 3 cohorts

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Tuebingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32476053DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Axel Franz

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Böckmann

CONTACT

+49707129katrin.boeckmann@med.uni-tuebingen.de

Axel Franz, MD

CONTACT

+49707129axel.franz@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

December 24, 2018

Study Start

April 3, 2017

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

December 24, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)