Intestinal failure / Chronic Intestinal Failure
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Children, newly diagnosed with intestinal failure in the Erasmus MC-Sophia Children*s Hospital. Three groups of children will be included: 1. Children with congenital gastro-intestinal anomalies with involvement of the small intestine, independent of expected use of parenteral nutrition. 2. Neonates with an expected use of parenteral nutrition >= 1 week after a gastrointestinal intervention (laparotomy). 3. Children with a (suspected) motility disorder or intrinsic disorder of the intestinal mucosa (enteropathy) with an expected use of parenteral nutrition > 2 weeks and children with an expected use of parenteral nutrition >= 1 week after a gastrointestinal intervention (laparotomy) after the neonatal period. In addition, all children already known with intestinal failure and dependent on home parenteral nutrition are eligible for this study (attending the intestinal failure team at the Sophia Children's Hospital and Emma Children's Hospital). Next to this, healthy children will be asked for the collection of stool samples (children of colleagues). Furthermore, children known with intestinal failure, but not dependent on home parenteral nutrition anymore (attending the intestinal failure team at the Sophia Children's Hospital) will be asked for the collection of stool samples. Also, parents of healthy infants will be asked for the collection of stool samples as comparison for the newly diagnosed infants with potential intestinal failure. In addition to this, infants undergoing inguinal hernia repair (who are often born preterm) will be asked for collection of stool samples, also as comparison.
Exclusion criteria
Exclusion criteria: A (potential) subject who meets any of the following criteria will be excluded from participation in this study: - Participating in an intervention study, interfering with primary outcome of this study - Absence of written informed consent - Insufficient knowledge of the Dutch language of the parents/caregivers and participants (if older than 12 years)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess if body composition (defined by %BF) at 6 months corrected age is associated with amount of PN provided (time-weighted area under the curve for % of total kilocalories provided by PN and duration of PN) until 6 months corrected age. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters: growth (weight, length/height, head circumference and calculated SD scores), bone health (bone mineral density, bone mineral content, and bone mineral apparent density, bone age and bone health index), other complications of parenteral nutrition (line sepsis, liver disease). Insufficient gut mass (citrulline), epithelial damage (urinary I-FABP), appetite regulation (ghrelin), intestinal homeostasis (16s ribosomal RNA, CD4/CD8 T-cells, B-cells, NK-cells and neutrophil granulocytes (blood) and levels of calprotectin, presence of neutrophil granulocytes, secretory IgA and description of the microbiome (stool)). | — |
Countries
Netherlands
Outcome results
None listed