To investigate the relationship between body composition and parenteral nutrition in children with intestinal failure at 6 months corrected age. The ultimate goil of this study is to optimize the treatment of children with intestinal failure by…
ID
Source
Brief title
Condition
- Gastrointestinal tract disorders congenital
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)).
Background summary
Intestinal failure is defined as a critical reduction of the gut mass or its
function below the minimum needed to absorb nutrients and fluids required for
adequate growth and development in children. The aims in the management of
children with intestinal failure are threefold; 1) maintaining growth and
development, 2) promoting intestinal adaptation, 3) preventing complications.
Children with intestinal failure are receiving parenteral nutrition, which is
associated with frequent complications, including impaired growth, decreased
bone mineral density and altered body composition with increased fat mass and
decreased fat free mass. The course of growth and body composition has not been
investigated starting from the diagnosis onwards and the relationship between
parenteral nutrition, growth and body composition is not yet clear. Measurement
of growth, bone health and body composition from diagnosis onwards would
therefore provide important information on nutritional needs of these children
and long-term effects of parenteral nutrition.
The overall goal in the treatment is to decrease and eventually stop the
parenteral nutrition. Current practice during this process is mostly *trial and
error* and there is no convenient marker to predict whether patients will be
able to wean off parenteral nutrition. The most important factor that is
delaying the process of decreasing parenteral nutrition is intolerance to
enteral nutrition. It is thought that insufficient gut mass, epithelial damage,
intestinal inflammation, impaired gastrointestinal motility and appetite may
play a role in intolerance to enteral nutrition. Gaining insight in these
parameters of influence would be very helpful in achieving intestinal autonomy
in these children. We hypothesize that children with intestinal failure who
have more parenteral nutrition have altered body composition, poorer growth and
bone health compared to children with intestinal failure already weaned off
parenteral nutrition or children with less parenteral nutrition. Furthermore,
we want to gain insight in the parameters of influence in weaning of parenteral
nutrition. With this study we want to add knowledge on how to improve the
treatment of children with IF in all three areas (maintaining growth, promoting
intestinal adaptation and preventing complications) in order to facilitate the
best long-term management and prognosis.
Study objective
To investigate the relationship between body composition and parenteral
nutrition in children with intestinal failure at 6 months corrected age. The
ultimate goil of this study is to optimize the treatment of children with
intestinal failure by adjusting the parenteral nutrition individually with
optimal growth and body composition and as little complications as possible.
Study design
Prospective, observational cohort study.
Study burden and risks
The PEA POD® is a registered product that we will use for its original purpose;
measuring body composition in neonates and infants. No adverse events have been
reported regarding the use of PEA POD®. The PEA POD® showed to be accurate and
feasible, with a limited test time and a warmed test chamber. The infant can be
observed through the window by the investigator, and the parents are able to
watch their child through the window as well. Furthermore, the PEA POD® has a
safety system, consisting a Cancel Test button and an Emergency STOP button
that ends the test immediately. The PEA POD® is used in the Sophia Children*s
Hospital for several years. Until now a total of 320 infants have been
investigated without any adverse events (MEC- 2012-444, MEC-2012-164 and
MEC-2014-379). Blood samples will be taken from indwelling lines placed or in
addition to blood drawings for clinical reasons. The risks associated with the
withdrawal of extra blood can be considered negligible and the burden will be
minimal. Assessments during follow-up will be performed at standard-care
outpatient clinic visits as much as possible.
In addition, healthy children (children of colleagues) will be asked for the
collection of the stool, this will be done twice and can be done at home.
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.
This will be done twice and can be brought to the appointment at the outpatient
clinic.
At the time of body composition measurement, a questionnaire on physical
activity will be filled in by the children/their parents.
Parents of healthy infants will be asked to collect one stool sample as a
comparison for infants with intestinal failure.
Wytemaweg 80
Rotterdam 3015CN
NL
Wytemaweg 80
Rotterdam 3015CN
NL
Listed location countries
Age
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)
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 |
|---|---|
| CCMO | NL51311.078.14 |