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Circulation in the smallest vessels in neonates suspected of necrotizing enterocolitis.


- candidate number6308
- NTR NumberNTR1951
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-aug-2009
- Secondary IDsMEC-2009-198 METC Erasmus Medical Center
- Public TitleCirculation in the smallest vessels in neonates suspected of necrotizing enterocolitis.
- Scientific TitleThe Microcirculatory Profile in Necrotizing Enterocolitis.
- ACRONYMMicrocirculation & NEC
- hypothesisThe microcirculatory profile is altered in infants with NEC.
- Healt Condition(s) or Problem(s) studiedNecrotizing enterocolitis
- Inclusion criteria1. 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 criteriaSevere cardiac and respiratory anomalies.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-sep-2009
- planned closingdate15-sep-2011
- Target number of participants180
- InterventionsThis 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.
- Primary outcomeTo 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 outcome1. 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.
- TimepointsNeonates 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.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A.E.C.J.M. Struijs
- CONTACT for SCIENTIFIC QUERIESDrs. A.E.C.J.M. Struijs
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD11-aug-2009 - 11-okt-2009


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