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Hyperbilirubinemia clinical trials

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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.

NCT ID: NCT00528138 Completed - Clinical trials for Perforated Appendicitis

Hyperbilirubinemia in Acute Appendicitis as a Predictor of Perforation

Start date: October 2007
Phase: N/A
Study type: Observational

It has recently been published that hyperbilirubinemia is a reliable marker for the preoperative diagnosis of perforated acute appendicitis. The investigators believe, based on their own previous publications, that C-reactive protein (CRP) with or without a white blood cell count and some other clinical parameters, are more specific markers for the preoperative diagnosis of perforated acute appendicitis. The purpose of this study is to prospectively compare the specificity and sensitivity of hyperbilirubinemia CRP, white blood cell count and other clinical parameters for the preoperative diagnosis of acute appendicitis.

NCT ID: NCT00461799 Completed - Clinical trials for Crigler-Najjar Syndrome

Orlistat Treatment of Crigler-Najjar Disease

Start date: September 2003
Phase: N/A
Study type: Interventional

The purpose of this study was to determine whether orlistat is effective in decreasing plasma unconjugated bilirubin levels in patients with Crigler-Najjar disease.

NCT ID: NCT00383318 Completed - Jaundice Clinical Trials

Demographic, Metabolic, and Genomic Description of Neonates With Severe Hyperbilirubinemia

Start date: September 2006
Phase: N/A
Study type: Observational

The purpose of this study is to compare the demographic, metabolic, and genomic characteristics of patients who develop severe hyperbilirubinemia to patients who never developed a significant bilirubin level.

NCT ID: NCT00360204 Completed - Clinical trials for Postpartum Depression

Improving Health Outcomes for New Mothers and Babies

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

Because adherence to postnatal care guidelines across the United States (U.S.) is poor, newborns and mothers often are placed at undue risk for adverse medical and social outcomes. This study aims to evaluate an alternative model of care and improve healthcare delivery to and reduce health disparities for "well" newborns and mothers after hospital discharge by using single postnatal home nurse visits. The principal investigator has previously shown a reduction in poor outcomes for infants who receive a home visit after discharge when studied retrospectively. The proposed research will build on the previous study and prospectively evaluate the impact of a single home nursing visit on morbidities and health disparities for newborns and mothers in a randomized, controlled trial involving 1154 mother/infant breastfeeding dyads. Home visits should guarantee detailed assessment during an at-risk period of infancy and motherhood, where medical and social problems can be recognized, anticipated, and/or treated, and can bridge the gap between hospital care and primary care. The investigators' program, The Nurses for Infants Through Teaching and Assessment after the NurserY (NITTANY) Initiative, also will consider the cost-effectiveness of home visitation compared with guidelines-adherent outpatient clinic care.

NCT ID: NCT00288600 Completed - Hyperbilirubinemia Clinical Trials

Efficacy of High-dose Intravenous Immunoglobulin Therapy for Hyperbilirubinemia Due Rh Hemolytic Disease

Start date: October 2006
Phase: Phase 4
Study type: Interventional

The use of intravenous immunoglobulin G (IVIG) therapy has been reported in hyperbilirubinemia of Rh hemolytic disease but we don't have enough evidences for it. Human Immunoglobulin is considered an alternative to delay the hemolytic process and consequently reduce the number of exchange transfusions and transfusions of red cells concentrate, thus diminishing the risk of transmitting transfusional therapies-related diseases. OBJECTIVE: To determine the effect of IVIG in decreasing the incidence and severity of neonatal immune hemolytic jaundice due to Rh hemolytic disease reducing the need for exchange transfusion as a primary goal in these babies. METHODS: This will be a randomized, double blind, clinical trial involving all newborns with risk of significant hyperbilirubinemia due to direct Coombs-positive Rh hemolytic disease. The primary goal will be need for exchange transfusion and others are: incidence of late anemia, kernicterus and deafness Babies were randomly assigned into two groups: group 1 (study group) received phototherapy plus IVIG (500 mg/kg); and group 2 (control group) received phototherapy and normal saline solution (10 ml/Kg) in the first 6 hours of life. Exchange transfusion was carried out in any group if at any time the bilirubin level reached 340 micromol/l (20 mg/dl) or more, or rose by 8.5 micromol/l per h (0.5 mg/dl per h). Adverse effects will be related in two groups. Parents informed consent will be asked in pre-natal time.

NCT ID: NCT00154999 Completed - Clinical trials for Hyperbilirubinemia, Neonatal

The Predictors of the Neonatal Hyperbilirubinemia

Start date: April 2005
Phase: N/A
Study type: Observational

The oxygen tension increases more than 3 times from fetus to neonate. The oxidant stress happens. And it will cause the destruction of RBC. So, we propose that the ROS may play an important role of neonatal hyperbilirubinemia. There is strong association between the bilirubin level and ROS levels at 3 days old in our pilot study.

NCT ID: NCT00115544 Completed - Hyperbilirubinemia Clinical Trials

Safety and Pharmacology of Stanate

Start date: September 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effect and safety of Stanate (stannsoporfin) in infants who are at risk for an exchange transfusion and meet the criteria of the protocol.

NCT ID: NCT00114543 Completed - Infant, Premature Clinical Trials

Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight

Phototherapy
Start date: September 2002
Phase: Phase 3
Study type: Interventional

This multi-center, randomized clinical trial compared different bilirubin levels as thresholds for timing of phototherapy in extremely low birth weight infants. The primary hypothesis was that there would be no difference in death or neurodevelopmental impairment at 18-22 months corrected age in infants treated by either aggressive or conservative threshold limits. 1,978 infants were enrolled.

NCT ID: NCT00004382 Completed - Hyperbilirubinemia Clinical Trials

Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns

Start date: December 1999
Phase: Phase 2
Study type: Interventional

OBJECTIVES: I. Compare the effectiveness of a single dose of tin mesoporphyrin and special blue light phototherapy in controlling hyperbilirubinemia in premature newborns in Greece. II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy without adverse effects in these newborns.