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Cyanotic Heart Disease clinical trials

View clinical trials related to Cyanotic Heart Disease.

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NCT ID: NCT03255564 Completed - Calprotectin Clinical Trials

Monitor Faecal Calprotectin Concentration in Infants With Heart Defects

Start date: May 1, 2018
Phase:
Study type: Observational

Infants born with heart problems are at risk of developing gut disease due to reduced blood flow to the intestines which can result in poor weight gain, surgery and even death. At present, doctors are often unaware of any gut problems until clinical symptoms present (poor feed tolerance, blood stained stools or bloated stomach) which is often too late to prevent gut damage. Earlier diagnosis of gut disease may now be possible; calprotectin is produced when the gut is inflamed and can be found in faeces and blood. Calprotectin levels have been shown to be a reliable marker in diagnosing gut disease in premature infants. To date, calprotectin levels have not been monitored in infants with cardiac defects, who like premature infants are at high risk of gut disease but the cause of gut disease is different to that seen in premature infants and therefore requires specific monitoring. This study will implement a high risk feeding protocol which has been adapted from current feeding practices from the United States; the aim being to promote weight gain without increasing the risk of gut inflammation. Furthermore, the study will validate whether faecal calprotectin is a useful non-invasive marker in identifying gut disease in infants with cardiac defects. Currently, infants are diagnosed with necrotising enterocolitis by an abdominal X-ray (current 'Gold Standard'); infants who have a positive diagnosis will have faecal calprotectin levels cross-checked. From this data, cut-off values will be established which will provide data to diagnose necrotising enterocolitis eliminating the need for X-rays (radiation). Secondly, faecal calprotectin levels will be measured at strategic time points (longitudinal data) linked to increased risk of gut damage (following cardiac surgery and feeding) which will then be cross-checked against infants that developed NEC to identify whether high risk infants had raised calprotectin levels earlier.

NCT ID: NCT02237014 Completed - Clinical trials for Cyanotic Heart Disease

Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease

Start date: November 2012
Phase: N/A
Study type: Observational

Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic interventions (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be delayed and or inadequate. By doing this study the investigators will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.