No registrations found.
ID
Source
Brief title
Health condition
necrotizing enterocolitis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our 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 outcome
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.
The study parameter to answer our second objective is:
- Quality of general movements (motor-optimality score)
Study objective
Intestinal tissue oxygen extraction, IFABP levels and plasma citrulline levels relate to time to full enteral feeding after Necrotizing Enterocolitis in preterm infants
Study design
NA
Intervention
none: observational
kinderarts-neonatoloog, afdeling neonatologie
Beatrix Kinderziekenhuis, UMC Groningen
Huispostcode: CA 51
Hanzeplein 1
Postbus 30001
Groningen 9700 RB
The Netherlands
050-3614215
e.kooi@umcg.nl
kinderarts-neonatoloog, afdeling neonatologie
Beatrix Kinderziekenhuis, UMC Groningen
Huispostcode: CA 51
Hanzeplein 1
Postbus 30001
Groningen 9700 RB
The Netherlands
050-3614215
e.kooi@umcg.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4664 |
| NTR-old | NTR4816 |
| Other | : METc2014/283 |