Congenital Heart Disease Clinical Trial
Official title:
Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease
Prematurely born infants with ductal-dependent congenital heart disease (CHD) are at
increased risk to develop necrotizing enterocolitis (NEC). Abnormal left to right blood flow
through a patent ductus arteriosus can cause intestinal ischemia and compromise the
gastrointestinal tract as a barrier to infection. In some infants, bacterial translocation
leads to NEC which may result in death, intestinal perforation, cholestasis and, at the very
least, feeding problems. Predicting which infants with CHD will develop NEC will potentially
decrease the severity of disease if interventions were started earlier.
Near-infrared spectroscopy (NIRS) allows determination of regional oxygen saturation levels
in tissues such as brain, kidney, and as recently reported, intestine. This study will test
whether or not decreasing intestinal oxygen saturations can predict the development of NEC
in this at risk population before the symptoms become severe. NIRS probes will be placed on
the forehead, flank and abdomen of eligible infants and regional oxygen saturations will be
recorded prospectively and continuously with the clinical care team blinded to the data. The
development of NEC and significant feeding problems will then be correlated with the
regional oxygen saturations to determine whether decreased intestinal oxygen saturations
predicted early signs and symptoms of NEC.
We anticipate generating pilot data in 30 infants who meet inclusion criteria. Support of
this research will be provided partially by Somanetics, the manufacturer of the INVOS
regional oxygen saturation monitors. They will, however, have no control over the data
generated by this study.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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