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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126372
First Posted: May 19, 2010
Last Update Posted: August 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Utah
May 17, 2010
May 19, 2010
August 13, 2013
May 2010
June 2013   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01126372 on ClinicalTrials.gov Archive Site
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Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease
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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Infants admitted into the NICU at PCMC (Salt Lake City, UT) with a prostaglandin-dependent congenital heart defect (CHD).
  • Congenital Heart Disease
  • Prematurity
  • Necrotizing Enterocolitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 1 Month   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01126372
40795
No
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Christian Con Yost, University of Utah
University of Utah
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Principal Investigator: Christian C Yost, MD University of Utah
University of Utah
August 2013