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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01126372
• Other study ID #: 40795
• Status: Completed
• Phase: N/A
• First received: May 17, 2010
• Last updated: August 9, 2013
• Start date: May 2010
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Heart Disease
• Enterocolitis
• Enterocolitis, Necrotizing
• Heart Defects, Congenital
• Heart Diseases
• Necrotizing Enterocolitis
• Premature Birth
• Prematurity

Locations

Country	Name	City	State
United States	Primary Children's Medical Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate intestinal oxygen saturations using NIRS to predict the development of NEC.	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.	2 months	No