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Hyperbilirubinemia clinical trials

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NCT ID: NCT02774434 Completed - Neonatal Jaundice Clinical Trials

Efficacy Study of the Draeger Jaundice Meter (JM-105) in Neonates of ≥ 24 Weeks of Gestational Age

Start date: November 2016
Phase: N/A
Study type: Interventional

The Canadian Pediatric Society recently published guidelines to monitor bilirubin levels and as part of standard of care all hospitalized newborns are routinely monitored for the development of high bilirubin or jaundice every 8-12 hours. One device approved and used in both Canada and the United States is the Draeger Jaundice Meter JM-103, a non-invasive medical device. It has been proven to be effective in patients >35 weeks gestational age. Recently the JM-103 has been upgraded to include a bigger touch screen, greater storage and functionality. The rest of the features of the JM-103 and JM-105 are identical. In order to test the accuracy of the JM-105 neonates from ≥ 24 weeks gestational age who have or have not undergone phototherapy will be prospectively monitored for transcutaneous bilirubin (TcB) using the JM-105. The measurements will be compared to a physician-ordered total serum bilirubin (TSB).

NCT ID: NCT02691156 Completed - Infant, Premature Clinical Trials

Bilirubin Binding Capacity to Assess Bilirubin Load in Preterm Infants

Start date: February 1, 2016
Phase:
Study type: Observational

Most preterm newborns are managed by phototherapy to reverse hyperbilirubinemia with the intent to prevent bilirubin neurotoxicity. A threshold-based relationship between a specific total bilirubin level and need for intervention has been elusive. This is most likely due to other biomarkers such as hemolysis, developmental maturation, concurrent illnesses, or even interventions, may impede bilirubin/albumin binding. The over-prescription of phototherapy has impacted clinical and family-centered care, and in the extreme preterm infants, it may have augmented their risk of mortality. Thus, the opportunity to individualize phototherapy in in order to reduce its use is unique. The investigators have assembled a transdisciplinary team to examine critical unanswered questions including the role of bilirubin binding capacity (BBC) of an individual during the first week of life in the context of clinical modifiers and antecedents for a domain of bilirubin-induced neurologic disorders, that includes neuro-anatomical, hearing, visual and developmental processing impairments. In this study, the investigator will evaluate two new innovative nanotechniques to quantify bilirubin load for the first time in the context of a clinical decision algorithm to identify those most at risk for any bilirubin-related neurotoxicity. The investigators anticipate that knowledge gained from this study will lead to ethically testable hypotheses to individualize the prescription of phototherapy.

NCT ID: NCT02625688 Completed - Jaundice Neonatal Clinical Trials

The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion

Start date: August 2013
Phase: N/A
Study type: Interventional

Delayed cord clamping (DCC) has been a subject of extensive research for the last couple of years. Based on published data, numerous neonatal benefits have been suggested such as increased hemoglobin and ferritin levels both at birth and longer term. Available systematic reviews of DCC versus early cord clamping (ECC) reveal that it may also contribute to other neonatal outcomes including polycythemia and hyperbilirubinemia. A review published nearly 10 years ago regarding late umbilical cord clamping revealed only 4 studies which as a second objective assessed whether the time of cord clamping was associated with an increased risk of polycythemia and hyperbilirubinemia during the first week of life. Two studies reported that neonates with DCC had bilirubin levels >15 mg/dl. No information is provided on what hour of life the bilirubin levels were measured exactly. In this randomized control study the investigators would like to determine if delayed cord clamping or cord milking during labor increases the risk of hyperbilirubinaemia (requiring phototherapy) in term infants.

NCT ID: NCT02613676 Completed - Neonatal Jaundice Clinical Trials

Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns

Start date: August 2015
Phase: N/A
Study type: Interventional

In South Africa, healthy term newborns are usually discharged early (<72 hours after delivery). Many studies have shown that hospital readmission rates have increased with this practice, and jaundice or hyperbilirubinemia is the most common cause of readmission of newborns. Peak serum bilirubin levels usually occur on postnatal days 3-5, by when many have already been discharged putting the infant at increased risk of severe hyperbilirubinemia. Severe neonatal jaundice still constitutes an important cause of neonatal mortality and morbidity in Africa. Screening all newborns for the risk of severe hyperbilirubinemia before hospital could help in early identification of hyperbilirubinemia and early intervention and potentially prevent unwanted consequences like bilirubin induced neurological dysfunction. However, there are conflicting recommendations on the use of universal transcutaneous bilirubin screening for jaundice in all newborns before hospital discharge.

NCT ID: NCT02612207 Completed - Jaundice, Neonatal Clinical Trials

Point-of-Care System for Determination of Bilirubin Capacity in Neonates

Start date: August 1, 2015
Phase:
Study type: Observational

The aims of this observational bench project are to validate the performance of the miniaturized and modernized hematofluorometer that measures bilirubin capacity into a product and is suitable for operation in various point of care environments w in the management of preterm neonates.

NCT ID: NCT02532673 Completed - HIV/AIDS Clinical Trials

Impact of Hyperbilirubinemia Among HIV Patients Treated With Atazanavir

Start date: August 2014
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether HIV patients on Atazanavir who have Hyperbilirubinemia have different outcomes from those without Hyperbilirubinemia.

NCT ID: NCT02446951 Completed - Hyperbilirubinemia Clinical Trials

Implementation of a Clinical Decision Rule for Treatment of Neonatal Jaundice in the Emergency Department

Start date: January 2015
Phase:
Study type: Observational

Jaundice is a condition caused by elevated levels of bilirubin in the body otherwise known as hyperbilirubinemia. It occurs when there is an increase in bilirubin production or normal production with problems eliminating it from the body. Serum levels of bilirubin in excess of 5 mg/dL signifies clinical jaundice, yet more than half of full term infants experience these levels within the first week of life. For those patients who have markedly elevated serum bilirubin levels, which phototherapy cannot sufficiently treat, the use of exchange transfusions is a viable option within the hospital setting. In comparison, bili-blankets have been used as a form of phototherapy for those patients being treated in a home-based setting to reduce the likelihood of hospital readmissions.

NCT ID: NCT02361788 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Study on Newborn Babies With a Yellow Skin Color (Neonatal Jaundice Study)

Start date: January 28, 2015
Phase:
Study type: Observational

Background: Neonatal hyperbilirubinemia is the most common reason for admission in the neonatal period (first month of life) worldwide and at SMRU. The skin of the newborn baby becomes jaundiced, which is caused by a high level of bilirubin in the blood. In some neonates the level of bilirubin increases to a level that can cause braindamage or even death. There are different causes known that can lead to higher levels of bilirubin, for example G6PD deficiency and prematurity. In case of neonatal hyperbilirubinemia the neonate needs to be treated with phototherapy (blue light therapy). If there is prolonged jaundice (≥ 21 days), further investigations needs to be done. Objectives: Primary objective: To determine the etiology of neonatal hyperbilirubinemia in neonates with a gestational age of ≥ 28 weeks from the refugee and migrant population, on the Thai-Myanmar border. Secondary objective: - Establishing the incidence of neonatal hyperbilirubinemia - Determine the risk factors for the development of neonatal hyperbilirubinemia - Determine the incidence of prolonged neonatal jaundice - Determine the neurodevelopmental outcome, at the age of 6 and 12 months - Determine the body composition, using air-displacement plethysmography, at birth, 1, 2 and 3 months of age - Determine the incidence of anaemia and illness episodes during the first year of life - Determine the incidence of helminthic infection at the age of one year - Assess the knowledge level and misbeliefs on neonatal hyperbilirubinemia among the mothers and SMRU health care staff Research design: The study will conduct an exhaustive prospective descriptive study, all eligible newborns will be enrolled after obtaining the informed consent from their mothers. During pregnancy and delivery we will collect clinical data about the mother. At birth we will take umbilical cord blood (9 ml) to test for different causes of neonatal hyperbilirubinemia. In the first week of life we plan 4 moments to measure the bilirubin and hematocrit level (0.05 ml), weight and ask questions about feeding and other practices. Based on the bilirubin results we will determine whether the neonate needs phototherapy. After the first week we weekly follow-up will be conducted and in case of visible jaundice we will measure the bilirubin level. If the neonate is still jaundiced after the age of 21 days we will further investigate the cause. In the infant period, until the age of one year, we plan to have monthly follow-up to assess the health and growth of the child and at the age of 3, 6 and 12 months we will do a neurodevelopmental test. An improved understanding of the pathological processes contributing to the development of neonatal hyperbilirubinemia is needed in order to to identify neonates at risk and develop improved management.

NCT ID: NCT02154165 Completed - Clinical trials for Uncomplicated Neonatal Hyperbilirubinemia

Comparison Between Turquoise and Blue Light in Treatment of Neonatal Jaundice Using Light Emission Diodes

Start date: January 2013
Phase: N/A
Study type: Interventional

The optimal wavelength for phototherapy for neonatal jaundice remains to be clarified by clinical studies. Previous iv vivo studies have shown that turquoise light at wavelength about 490 nm is more efficacious than blue light at wavelength 460 nm, which is the golden standard in phototherapy treatment today. Though, previous studies used light tubes, today we use light emitting diodes (LED'S). The overall aim of this study was therefore to compare the efficacy of turquoise LED's versus blue LED's for decreasing total serum bilirubin in neonates with gestational age > 33 weeks and uncomplicated hyperbilirubinemia.

NCT ID: NCT02033096 Completed - Clinical trials for Neonatal Hyperbilirubinemia

Observational Follow-up of Participants From Clinical Trial 64,185-202 (NCT00850993)

Start date: October 20, 2008
Phase:
Study type: Observational

Observational follow-up of participants from earlier interventional trial 64,185-202 (NCT00850993). No interventions were administered during this follow-up study.