Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease
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|ClinicalTrials.gov Identifier: NCT01126372|
Recruitment Status : Completed
First Posted : May 19, 2010
Last Update Posted : August 13, 2013
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.
|Condition or disease|
|Congenital Heart Disease Prematurity Necrotizing Enterocolitis|
|Study Type :||Observational|
|Actual Enrollment :||6 participants|
|Official Title:||Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
- Evaluate intestinal oxygen saturations using NIRS to predict the development of NEC. [ Time Frame: 2 months ]Using NIRS to test whether or not decreasing intestinal oxygen saturations can predict the development of NEC in this at risk population before the symptoms become severe.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01126372
|United States, Utah|
|Primary Children's Medical Center|
|Salt Lake City, Utah, United States, 84112|
|Principal Investigator:||Christian C Yost, MD||University of Utah|