Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease



Status:Completed
Conditions:Colitis, Peripheral Vascular Disease, Cardiology, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Gastroenterology
Healthy:No
Age Range:Any
Updated:5/27/2013
Start Date:May 2010
End Date:June 2013
Contact:Christian C Yost, MD
Email:christian.yost@hsc.utah.edu
Phone:801-581-7052

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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.


Inclusion Criteria:

- >/+ 30 and 0/7 weeks gestation age at birth

- Anticipated time to surgical repair is > 7 days

- Meets criteria for management via the PCMC CHD feeding protocol

Exclusion Criteria:

- Any extracardiac major congenital anomalies
We found this trial at
1
site
100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
(801) 662-1000
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from
Salt Lake City, UT
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