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

The Microcirculatory Profile in Necrotizing Enterocolitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23436

Enrollment

180

Registered

2009-08-11

Start date

2009-09-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrotizing enterocolitis (NEC). In Dutch: necrotiserende enterocolitis.

Interventions

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

2. Near infrared spectroscopy (NIRS): non-invasive measurement of tissue oxygenation

3. Doppler: flow velocity of superior mesenteric artery.

Eligibility

Inclusion criteria

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

Exclusion criteria: Severe cardiac and respiratory anomalies.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactA.E.C.J.M. Struijs

Dr. Molewaterplein 60, Sk-1324

a.e.c.j.m.struijs@erasmusmc.nl+31 (0)10-7036889

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)