After NEC
- Conditions
- necrotizing enterocolitis
- Registration Number
- NL-OMON22150
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria: Infants with a gestational age <37 weeks with confirmed pneumatosis intestinalis on x-ray, or suspected NEC > Bells stage 1, admitted on the NICU in Groningen.
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Large chromosomal abnormalities
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Our main study parameters are based on the following questions:<br /><br>- Intestinal oxygen saturation (and extraction) measured with NIRS and the time it takes to reach full enteral feeding after developing NEC<br /><br>- The measurement of urinary I-FABPs and the time it takes to reach full enteral feeding after developing NEC <br /><br>- The measurement of plasma citrulline and the time it takes to reach full enteral feeding after developing NEC<br><br /><br /><br>Our main study parameters consist of:<br /><br>-Intestinal oxygen saturation (rintSO2) <br /><br>-Intestinal FTOE<br /><br>-Concentration of urinary I-FABP<br /><br>-Plasma Citrulline levels
- Secondary Outcome Measures
Name Time Method Our second objective is to assess the relation between the time it takes to reach full enteral feeding (more or less than 10 days) after developing NEC and neurodevelopmental outcome measured with the assessment of the quality of GMs (and the calculation of the motor-optimality score) at the term and three months post term age. <br><br /><br /><br>The study parameter to answer our second objective is:<br /><br>-Quality of general movements (motor-optimality score)