The clinical value of measuring gastric emptying in children with a severe generalized cerebral palsy

Children with severe motor and intellectual disabilities (SMID) suffer from
much co-morbidity among which digestive problems such as gastro-oesophageal
reflux disease (GORD) and constipation. Impaired motility is often the basis of
these disorders and this is also true for delayed gastric emptying (DGE). The
latter causes any number of symptoms such as feeling bloated, early satiety,
nausea and can even worsen existing GOR. Because of these complaints the eating
experience is very unpleasant and this negatively impacts nutritional state.

Gastric emptying (GE) hasn*t been studied much in SMID children and existing
methods of measuring GE like scintigraphy aren*t suitable for children because
of the long time spent before a gamma camera and the burden of radiation. The
last couple of years the 13C breath test is being used more and more in
research. It is a very suitable test for these children because of its
simplicity, lack of radiation exposure and because children do not have to
actively cooperate.

The objective of the study is to determine what the clinical value is of
measuring GE of liquids in 50 SMID children. The primary study parameter is how
often DGE of liquids occurs in this study group. Secondary study parameters
include reproducibility of the measurement, but also the influence of GORD and
a gastrostomy on GE will be studied.

It is a non-therapeutic intervention study in which in 50 children GE of
liquids will be measured using the 13C breath test. In 40 children GE will be
measured once, in the remaining 10 children the test will be performed twice
with an interval of one week. During the measurement a testmeal will be given
after fasting for 3 hours and subsequently breath samples will be collected
during the next 4 hours on regular intervals.

If participating children take medication that effects gastric emptying
(Domperidon and Prepulsid), we ask the parents to temporarily withhold these
for three days prior to the measurement.

The burden of this study is being kept to a minimum by keeping the time that
children can*t eat or drink as short as possible. If there are any clues of
active resistance the measurement will be stopped immediately. Participants in
this study are not at risk of any health hazards since the substrate 13C is
completely safe.