After necrotizing enterocolitis in preterm infants: The time to reach full enteral feeding and its relation to intestinal recovery and neurocognitive development.
Completed
- Conditions
- Intestinal inflammation of the preterm infantNEC1001796910028920
- Registration Number
- NL-OMON40857
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- 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
Intraventricular hemorrhage/Perventricular hemorrhage >grade 2
Use of dexamethason
Congenital heart deformities other than patent ductus arteriosus
Abdominal wall defects/other congenital gastroenteral deformities (ie atresia, microcolon)
Parents/caretakers who are unable to understand Dutch or English
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Our main study parameters are based on the following questions:<br /><br>- Intestinal oxygen saturation (and extraction) measured with NIRS and the time<br /><br>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<br /><br>enteral feeding after developing NEC<br /><br>- The measurement of plasma citrulline and the time it takes to reach full<br /><br>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</p><br>
- Secondary Outcome Measures
Name Time Method <p>Our second objective is to assess the relation between the time it takes to<br /><br>reach full enteral feeding (more or less than 10 days) after developing NEC and<br /><br>neurodevelopmental outcome measured with the assessment of the quality of GMs<br /><br>(and the calculation of the motor-optimality score) at the term and three<br /><br>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)</p><br>