Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease
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Purpose
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 |
|---|
|
Congenital Heart Disease Prematurity Necrotizing Enterocolitis |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease |
Eligibility| Ages Eligible for Study: | up to 1 Month |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Infants admitted into the NICU at PCMC (Salt Lake City, UT) with a prostaglandin-dependent congenital heart defect (CHD).
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
Contacts and Locations| Contact: Christian C Yost, MD | 801-581-7052 | christian.yost@hsc.utah.edu |
| Contact: Karen Osborne, RN | 801-213-3298 | karen.osborne@hsc.utah.edu |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Christian C Yost, MD 801-581-7052 christian.yost@hsc.utah.edu | |
| Principal Investigator: Christian C Yost, MD | |
| Sub-Investigator: Donald M Null, MD | |
| Sub-Investigator: Deborah U Frank, MD | |
| Sub-Investigator: Robert J DiGeronimo, MD | |
| Sub-Investigator: Vicki Greenland, RN | |
| Sub-Investigator: Kim Friddle, MS, NNP | |
| Principal Investigator: | Christian C Yost, MD | University of Utah |
More Information
No publications provided
| Responsible Party: | Christian Con Yost, University of Utah |
| ClinicalTrials.gov Identifier: | NCT01126372 History of Changes |
| Other Study ID Numbers: | 40795 |
| Study First Received: | May 17, 2010 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Utah:
|
Prostaglandin-dependent Congenital Heart Disease Prematurity Feeding intolerances Necrotizing Enterocolitis |
Regional Oxygen Saturation Near Infrared Spectroscopy Somanetics INVOS Oxyalert |
Additional relevant MeSH terms:
|
Enterocolitis Heart Diseases Heart Defects, Congenital Enterocolitis, Necrotizing Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Intestinal Diseases Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on June 13, 2013