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

NCT01126372 | Completed

• 1 other identifier: 40795
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• \>/+ 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

You may not qualify if:

• Any extracardiac major congenital anomalies

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Primary Children's Medical Center

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Premature Birth; Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Christian C Yost, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

US (1)