Clinical trial NCT01126372: Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease
Official title: Prediction of Feeding Problems in Prostaglandin-dependent Prematurely Born Infants With Congenital Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Prematurity
Necrotizing Enterocolitis
Keywords: Prostaglandin-dependent Congenital Heart Disease
Prematurity
Feeding intolerances
Necrotizing Enterocolitis
Regional Oxygen Saturation
Near Infrared Spectroscopy
Somanetics INVOS Oxyalert
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 6
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants admitted into the NICU at PCMC (Salt Lake City, UT) with a prostaglandin-dependent congenital heart defect (CHD).

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Evaluate intestinal oxygen saturations using NIRS to predict the development of NEC.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
Study officials:
affiliation: University of Utah
name: Christian C Yost, MD
role: PRINCIPAL_INVESTIGATOR
References: