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

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01126372
First received: May 17, 2010
Last updated: August 9, 2013
Last verified: August 2013
  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

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Evaluate intestinal oxygen saturations using NIRS to predict the development of NEC. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 6
Study Start Date: May 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126372

Locations
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
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: August 9, 2013
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 April 17, 2014