|- candidate number||25246|
|- NTR Number||NTR6080|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-sep-2016|
|- Secondary IDs||MEC-2015-002 |
|- Public Title||Long-term monitoring of children with intestinal failure|
|- Scientific Title||Long-term monitoring of children with intestinal failure|
|- ACRONYM||Trompet study|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Intestinal damage, Growth, Monitoring, Body composition|
|- 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||1-mrt-2015|
|- planned closingdate||1-mrt-2020|
|- Target number of participants||62|
|- 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.
|- Timepoints||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. |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD JM Hulst|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD JM Hulst|
|- Sponsor/Initiator ||Erasmus Medical Center, Sophia Children's Hospital|
(Source(s) of Monetary or Material Support)
|Erasmus Medical Center, Sophia Children's Hospital|
|- Brief summary|
|- Main changes (audit trail)||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.|
|- RECORD||1-sep-2016 - 25-nov-2016|