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van CCT (UK)


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After NEC


- candidate number19548
- NTR NumberNTR4816
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-sep-2014
- Secondary IDsMETc2014/283 
- Public TitleAfter NEC
- Scientific TitleAfter necrotizing enterocolitis in preterm infants: The time to reach full enteral feeding and its relation to intestinal recovery and neurocognitive development.
- ACRONYMNaNEC
- hypothesisIntestinal tissue oxygen extraction, IFABP levels and plasma citrulline levels relate to time to full enteral feeding after Necrotizing Enterocolitis in preterm infants
- Healt Condition(s) or Problem(s) studiedNecrotizing enterocolitis
- Inclusion criteriaIn 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 criteriaA 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-okt-2014
- planned closingdate31-mei-2017
- Target number of participants32
- Interventionsnone: observational
- Primary outcomeOur main study parameters are based on the following questions:
- Intestinal oxygen saturation (and extraction) measured with NIRS and the time it takes to reach full enteral feeding after developing NEC
- The measurement of urinary I-FABPs and the time it takes to reach full enteral feeding after developing NEC
- The measurement of plasma citrulline and the time it takes to reach full enteral feeding after developing NEC

Our main study parameters consist of:
- Intestinal oxygen saturation (rintSO2)
- Intestinal FTOE
- Concentration of urinary I-FABP
- Plasma Citrulline levels
- Secondary outcomeOur 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.

The study parameter to answer our second objective is:
- Quality of general movements (motor-optimality score)
- TimepointsNA
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES E.M.W. Kooi
- CONTACT for SCIENTIFIC QUERIES E.M.W. Kooi
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University of Groningen
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD25-sep-2014 - 10-jan-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl