ong-term monitoring of children with intestinal failure

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 245

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

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)

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess if body composition (defined by %BF) at 6 months corrected age is<br /><br>associated with amount of PN provided (time-weighted area under the curve for %<br /><br>of total kilocalories provided by PN and duration of PN) until 6 months<br /><br>corrected age.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters: growth (weight, length/height, head circumference<br /><br>and calculated SD scores), bone health (bone mineral density, bone mineral<br /><br>content, and bone mineral apparent density, bone age and bone health index),<br /><br>other complications of parenteral nutrition (line sepsis, liver disease).<br /><br>Insufficient gut mass (citrulline), epithelial damage (urinary I-FABP),<br /><br>appetite regulation (ghrelin), intestinal homeostasis (16s ribosomal RNA,<br /><br>CD4/CD8 T-cells, B-cells, NK-cells and neutrophil granulocytes (blood) and<br /><br>levels of calprotectin, presence of neutrophil granulocytes, secretory IgA and<br /><br>description of the microbiome (stool)).</p><br>