No registrations found.
ID
Source
Brief title
Health condition
Intestinal failure; body composition; growth; bone health.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Body composition measured, defined by %BF
Parenteral nutrition (time-weighted area under the curve for % of total kilocalories provided by parenteral nutrition and duration of PN)
Secondary outcome
Growth, defined by weight, length, head circumference and calculated SD scores. Mid-upper arm circumference scores.
Bone health, defined by bone mineral density (g/cm2), bone mineral content (g) and bone mineral apparent density (g/cm3), bone age and bone health index.
Background summary
In this prospective, observational study we investigate the relationship between body composition, growth and parenteral nutrition in children with intestinal failure. In addition, we investigate the bone health of children with intestinal failure.
Study objective
Children with intestinal failure who receive a profound percentage of total kilocalories by parenteral nutrition for aprolonged period have altered body composition, poorer growth and bone health compared to children with intestinal failure off parenteral nutrition or children with less parenteral nutrition.
Study design
The duration of the study for each subject will last two years. There will be 12 visits during this study, but only when the patient is admitted or visiting the outpatient clinic. For children already known with intestinal failure, there will be 8 visits.
Intervention
N/A
JM Hulst
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
0107036049
j.hulst@erasmusmc.nl
JM Hulst
Wytemaweg 80
Rotterdam 3015 CN
The Netherlands
0107036049
j.hulst@erasmusmc.nl
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 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.
Furthermore, children already known with intestinal failure who receive parenteral nutrition at home and visit the intestinal failure outpatient clinic will be included, both in the Erasmus MC - Sophia Children's Hospital and the AMC - Emma Children's Hospital.
Exclusion criteria
Participating in an intervention study, interfering with primary outcome of this study.
Absence of written informed consent
Insufficient knowledge of the Dutch language
Design
Recruitment
IPD sharing statement
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 | NL5892 |
| NTR-old | NTR6080 |
| Other | MEC : 2015-002 |