No registrations found.
ID
Source
Brief title
Health condition
Necrotizing enterocolitis (NEC). In Dutch: necrotiserende enterocolitis.
Sponsors and support
Intervention
Outcome measures
Primary outcome
To determine the microcirculatory profile in infants with persistent feeding intolerance or suspected NEC. We would like to determine whether NEC is associated with a regional decreased microcirculation.
Secondary outcome
1. To determine whether microcirculatory measurements can be used to predict which infants will need surgical intervention for NEC;
2. To quantify the mesenteric arterial circulation during laparotomy using SDF and to correlate these values with the ones obtained prior to surgery;
3. To determine the correlation between microcirculatory and macrocirculatory measurements (RR);
4. To evaluate mesenterial vascular responses by in vitro pharmacology and especially focus on the role of NO and his products;
5. To evaluate whether surgical intervention improves microcirculation.
Background summary
The microcirculation might play an important role in the pathogenesis of necrotizing enterocolitis. We would like to determine the microcirculatory profile using different techniques (SDF, NIRS and Doppler) and perform basic scientific research to evaluate the mesenteric vascular response.
Study objective
The microcirculatory profile is altered in infants with NEC.
Study design
Neonates from group 1 and 2 will be followed for 7 consecutive days.
In case of an operative procedure for neonates in group 1, intra-operative measurements will be performed and for 3 days following surgery. Infants from group 3 will be used as control patients for the intra-operative measurements.
Intervention
This is an observational study. The following techniques will be used to monitor the microcirculatory profile in the groups described in inclusion criteria:
1. Sidestream darkfield imaging (SDF): non-invasive assessment microcirculation;
2. Near infrared spectroscopy (NIRS): non-invasive measurement of tissue oxygenation;
3. Doppler: flow velocity of superior mesenteric artery.
A.E.C.J.M. Struijs
Dr. Molewaterplein 60, Sk-1324
Rotterdam 3015 GJ
The Netherlands
+31 (0)10-7036889
a.e.c.j.m.struijs@erasmusmc.nl
A.E.C.J.M. Struijs
Dr. Molewaterplein 60, Sk-1324
Rotterdam 3015 GJ
The Netherlands
+31 (0)10-7036889
a.e.c.j.m.struijs@erasmusmc.nl
Inclusion criteria
1. Group 1: All neonates suspected of NEC or severe feeding intolerance;
2. Group 2: Control patients for group 1, matched for gender and age;
3. Group 3: neonates with congenital gastrointestinal pathology, ie atresia, gastroschisis, omphalocele.
Exclusion criteria
Severe cardiac and respiratory anomalies.
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 |
|---|---|
| NTR-new | NL1840 |
| NTR-old | NTR1951 |
| Other | METC Erasmus Medical Center : MEC-2009-198 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |