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Hyperbilirubinemia clinical trials

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NCT ID: NCT01109277 Completed - Clinical trials for Hyperbilirubinemia, Neonatal

Prediction of Neonatal Hyperbilirubinemia

2010ICTPAGR
Start date: April 2010
Phase: N/A
Study type: Observational

Objective: To develop an evidence-based strategy for assessing the risk of significant hyperbilirubinemia in healthy term and near-term (late-preterm) neonates. Hypothesis: A stepwise strategy which combines clinical parameters and serial non-invasive transcutaneous bilirubin (TcB) values could reliably predict significant neonatal hyperbilirubinemia. Methods: Data from neonates >34 weeks' gestation included in the registry for neonatal hyperbilirubinemia of the well-baby nursery of the University Hospital of Patras, from January 2008 to December 2010 will be reviewed. The registry includes prospectively collected data such as sex, gestational age, gestation and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding (daily), extension of jaundice, TcB measurements at intervals of 12+/-4 hours until discharge, total serum bilirubin values (if obtained), TcB or TSB measurements at follow-up, weight at discharge, need of phototherapy (inpatient or after discharge). TcB and TSB values are plotted on a hour-specific chart. A novel predictive nomogram based on TcB measurements (Varvarigou et al. Pediatrics 2009;124:1052-9) will be used to classify TcB values as high, intermediate, and low risk. Significant hyperbilirubinemia will be defined as a TSB value above the phototherapy threshold level according to the AAP 2004 guidelines Statistics: Independent and joint effects of various clinical factors on the development of significant hyperbilirubinemia will be evaluated by logistic regression analysis Cluster analysis and Chi-squared Automatic Interaction Detection (CHAID) tree method will be used to develop the strategy. At each step, CHAID chooses the independent (predictor) variable that has the strongest interaction with the dependent variable. Categories of each predictor are merged if they are not significantly different with respect to the dependent variable.

NCT ID: NCT00917007 Withdrawn - Neonatal Jaundice Clinical Trials

Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis

Start date: June 2009
Phase:
Study type: Observational

The purpose of this research study is to more accurately measure the amount of true red blood cell breakdown (hemolysis) in newborn babies with potentially problematic blood type mismatch with their mothers (ABO incompatibility), and to examine how the true level of red blood cell destruction relates to other laboratory tests obtained in newborns with jaundice. A better understanding of the true amount of red blood cell destruction that is caused by blood type mismatch, as well as how it relates with other laboratory tests ordered for ABO incompatibility and red blood cell destruction, would help avoid unnecessary testing, treatment and prolonged hospital stays in such babies.

NCT ID: NCT00916448 Completed - Sepsis Clinical Trials

The Effects of Atazanavir-induced Hyperbilirubinemia During Human Endotoxemia

Start date: May 2009
Phase: N/A
Study type: Interventional

Excessive inflammation, production of free radicals and vascular injury are considered the main contributors to the development of organ dysfunction in patients with severe infections and sepsis. The endogenously produced unconjugated bilirubin is one of the most powerful anti-oxidants of the human body and the administration of bilirubin in animal experiments has been shown to protect from inflammation-induced death. However, bilirubin for human administration is not yet available. Therefore, we wish to exploit one of the side effects of atazanavir, a registered drug currently used as a protease inhibitor in HIV infected patients. Atazanavir inhibits the enzyme UPD glucuronosyl transferase enzyme (UGT1A1) and therefore increases endogenously produced bilirubin levels moderately. To study the effect of hyperbilirubinemia during inflammation we will apply the human endotoxemia model. The human endotoxemia model permits elucidation of key players in the immune response to a gram negative stimulus in vivo, therefore serving as a useful tool to investigate potential novel therapeutic strategies in a standardized setting. We hypothesize that atazanavir-induced hyperbilirubinemia has beneficial anti-inflammatory and vascular effects during human endotoxemia.

NCT ID: NCT00850993 Terminated - Clinical trials for Hyperbilirubinemia, Neonatal

A Safety and Efficacy Trial of Stannsoporfin in Neonates With Hyperbilirubinemia

Start date: August 2008
Phase: Phase 2
Study type: Interventional

It is a normal process in the human body for red blood cells to die, which makes bilirubin. Bilirubin is cleared away through the liver. Some babies are born with livers that don't work well enough yet, or their red blood cells are dying too fast, so the baby looks yellow (jaundice). This means there is too much bilirubin in the body. It can be dangerous if a baby's bilirubin gets too high. Phototherapy is what they call the lights they shine on newborn babies to help the liver get rid of bilirubin. This study tests an experimental drug to see if it can reduce how much bilirubin is being made in the first place.

NCT ID: NCT00801619 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Bilicurves: Using Information Technology to Improve the Management of Neonatal Hyperbilirubinemia

Start date: November 2008
Phase: N/A
Study type: Observational

We will use information technology to integrate the 2004 American Academy of Pediatrics guidelines for management of neonatal hyperbilirubinemia with laboratory reporting of newborn bilirubin test results to improve physician adherence to the guidelines and quality of care.

NCT ID: NCT00741117 Terminated - Liver Disease Clinical Trials

Conjugated Hyperbilirubinemia and Pulse Oximetry

Start date: October 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to determine if higher levels of bilirubin in the blood of people with liver disease affects how accurate a pulse oximeter machine is able to measure the concentration of oxygen in the blood. Previous studies have reported conflicting results regarding the affect of high levels of bilirubin in the blood on the accuracy of the pulse oximeter reading. Initial studies showed an underestimation of the oxygen concentration in the presence of elevated bilirubin. Subsequent studies have suggested that high levels of bilirubin in the blood do not influence the accuracy of the pulse oximeter machine. However, recent reports in bone marrow transplant literature and our personal observations in patients with liver disease suggest that high bilirubin levels are associated with an overestimation of the oxygen concentration as measured by the pulse oximeter machine.

NCT ID: NCT00692224 Completed - Neonatal Jaundice Clinical Trials

Efficacy of Zinc in Reducing Hyperbilirubinemia Among High Risk Neonates - A Double Blind Randomized Trial

Start date: October 2005
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of 10 mg of oral zinc given daily between days 2 and 7 of life to term or near term neonates with serum bilirubin levels of more than 6 mg/dL at 24 ± 6 hours of life on hyperbilirubinemia and phototherapy.

NCT ID: NCT00677417 Completed - Clinical trials for Perforated Appendicitis

Diagnostic Value of Hyperbilirubinaemia as a Predictive Factor for Appendiceal Perforation in Acute Appendicitis

Start date: May 2008
Phase: N/A
Study type: Observational

The values of laboratory examinations which are useful for the diagnoses of appendicitis are white blood cell count (WBC), C-reactive protein (CRP) and erythrocyte blood sedimentation rate (ESR). However up to date there is no laboratory marker for the pre-operative diagnosis of appendiceal perforation in acute appendicitis. Recently hyperbilirubinaemia has been associated with appendiceal perforation. Aim of this retrospective study is therefore to investigate if hyperbilirubinaemia has a diagnostic value for the pre-operative diagnosis of appendiceal perforation in patients with appendicitis.

NCT ID: NCT00653874 Completed - Hyperbilirubinemia Clinical Trials

Transcutaneous Bilirubinometry in Healthy Term and Near-Term Neonates

Start date: November 2006
Phase: Phase 3
Study type: Interventional

Objectives: Bilirubin measured by transcutaneous bilirubinometry (TcB) is a reasonably accurate estimate of serum total bilirubin (STB). Observational studies indicate that replacing clinical assessment of bilirubin (CaB) with TcB may result in reduced need for blood sampling for STB estimation. Objective of this study was to determine if routine use of transcutaneous bilirubinometry decrease the need for blood sampling for confirmation of STB in healthy term and near term neonates? Study design: Study was conducted as a randomized controlled trial at a tertiary care neonatal unit. Healthy neonates born at 35 or more completed weeks of gestation were eligible for enrolment if they had clinically evident jaundice during first week of life. In each enrolled neonate, level of jaundice was assessed by two methods - CaB followed by TcB (BiliCheck®, SpectRx Inc, Norcross, GA). By random allocation method, one of these estimates was used for deciding the need for blood sampling to confirm STB. Need for blood sampling was defined to be present if the bilirubin assessed by the allocated method exceeded 80% of age-specific cut-off for phototherapy as per American Academy of Pediatrics 2004 guidelines. Study had ethics clearance and written informed consent was obtained from parents.

NCT ID: NCT00635375 Completed - Hyperbilirubinemia Clinical Trials

Comparative Study of Phototherapy for Hyperbilirubinemia

Start date: March 2008
Phase: N/A
Study type: Interventional

Hyperbilirubinemia is a common problem for term and preterm newborns in intensive care nurseries around the world. It is a condition in which there is too much bilirubin in the blood. Bilirubin is a substance that is naturally released when red blood cells break down. In the early newborn period, multiple factors lead to an abnormally elevated bilirubin level. Large amounts of bilirubin can circulate to tissues in the brain and may cause seizures or brain damage. About 6.1% of term newborns and a higher percentage of preterm newborns develop hyperbilirubinemia that requires treatment. Initiating treatment depends on many factors, including the cause of the hyperbilirubinemia, the level of serum indirect bilirubin, the rate of indirect bilirubin rise, and the age of the patient. The goal of treatment is to keep the level of bilirubin from rising to dangerous levels. The bilirubin molecule absorbs light. Therefore, treatment of hyperbilirubinemia involves exposure of the baby's skin to special blue spectrum light. Phototherapy is globally recognized as the standard of care for treatment of elevated indirect hyperbilirubinemia in the neonatal period. This light exposure converts water-insoluble indirect bilirubin to a more easily excreted soluble molecule. Over the last five years, several devices have been introduced that emit high intensity light in the blue portion of the visible light spectrum. However, despite frequent use of such therapy, the effectiveness of different phototherapy devices has not been adequately compared. The objective of this study is to compare the efficacy of the blue LED fiberoptic phototherapy with the metal halide spot phototherapy versus blue LED bank light phototherapy versus a combination of tandem therapy on lowering to total serum bilirubin.