To establish microcirculatory profiles using non-invasive diagnostic imaging in NEC.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
- Neonatal and perinatal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is to determine the microcirculation and vascular
reactivitiy in NEC.
Secondary outcome
Secondary study parameters are for example whether microcirculatory
measurements can be used to predict which infants will need surgical
intervention for NEC.
Background summary
Necrotizing enterocolitis (NEC) is a devastating gastrointestinal disease
mainly affecting premature neonates with a relatively high mortality and
morbidity. The microcirculation might play an important role in the
pathogenesis. Limited studies have been performed using non-invasive
radiological imaging tachniques to study the microcirculation in NEC.
Study objective
To establish microcirculatory profiles using non-invasive diagnostic imaging in
NEC.
Study design
Single centre, observational, prospective cohort study.
Study burden and risks
Subjects will have no direct benefits of participating in this study. We aim to
establish a microcirculatory profile as a non-invasive biomarker for the
disease progress of NEC.
No adverse events have been reported using the different diagnostic imaging
techniques (Sidestream Dark Field Imaging, Near Infrared Spectroscopy and
Doppler Ultrasound). The expected burden for the participants is very low, all
techniques are non-invasive and no radiation is involved. The only possible
burden could be that the measurements need to be performed daily and that some
minor manipulation may be required to obtain qualitatively good images.
Dr Molewaterplein 60, kamer Sk-1324
3015 GJ Rotterdam
NL
Dr Molewaterplein 60, kamer Sk-1324
3015 GJ Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Group 1:
- All neonates with sustained feeding intolerance and/or suspected NEC.
Group 2:
- Neonates without suspected NEC, matched for gender and gestational age with participants from group 1.
Group 3:
- All neonates with congenital gastrointestinal pathology.
For all groups: informed consent.
Exclusion criteria
- Severe cardiac anomaly
- Severe respiratory anomalies
- Severe anomalies of the central nervous system
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26661.078.09 |