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Jaundice clinical trials

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NCT ID: NCT03741803 Suspended - Jaundice, Neonatal Clinical Trials

Relationship Between Delayed Cord Clamping at Birth and Neonatal Bilirubin Levels in Parturients With a Prior Child Requiring Therapy for Neonatal Jaundice

Start date: November 9, 2018
Phase: N/A
Study type: Interventional

The purpose of the study is to determine if neonates (who already have an increased risk of hyperbilirubinemia due to mother's history of having previous neonate who received phototherapy for hyperbilirubinemia) have higher bilirubin levels 24 hours after birth with delayed cord clamping.

NCT ID: NCT03599258 Completed - Jaundice, Neonatal Clinical Trials

Comparison of Phototherapy Using Neolight Skylife Versus Standardized Phototherapy for Hyperbilirubinemia in Newborns

Start date: April 15, 2018
Phase: N/A
Study type: Interventional

Phototherapy has served as a primary treatment for hyperbilirubinemia in newborn populations. The light emitted through phototherapy interacts with bilirubin at the skin level to transform it into water-soluble products eliminated in urine and stool. Efficacy of phototherapy relies on the irradiance dispensed at the skin level by the treatment and on the surface area of skin exposed. The purpose of this Investigator-initiated, prospective, two-arm, randomized control investigation is to compare the effect of a novel, newly available, FDA cleared, phototherapy device (Neolight Skylife) with the standard phototherapy treatments used in HonorHealth newborn nurseries (Natus-Neo Blue Blanket and GE Bili Soft Blanket) on healthy, newborns ≥ 35 weeks + 0 days Gestational Age (GA) at the time of birth in the treatment of hyperbilirubinemia. We hypothesize that the unconjugated bilirubin level will be comparably reduced across each treatment arm from baseline to 12 and 24 hour intervals.

NCT ID: NCT03570775 Completed - Jaundice, Neonatal Clinical Trials

Effectiveness, Safety and Perceptions With the Use of One LED Sleeping Bag Device in the Treatment of Neonatal Jaundice

LEDlightT1
Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy to which a LED light mesh has been incorporated(a sleeping bag), comparing it with conventional hospital phototherapy. Methods: randomized controlled clinical trial with newborns more than 2000 g of birth weight hospitalized requiring phototherapy. The study protocol was evaluated and accepted by the San Ignacio Hospital and "Pontificia Universidad Javeriana" research committee. Informed consent was requested from parents and the authors declared no conflict of interest. Sample size and allocation: using the STATA 12 program, a sample size of 58 patients was calculated, 29 for each group, with significance level of 0.05, power of 80% and difference in bilirubin decreasing of at least 0,1 mg/dl/h with standard deviation of 0.14 mg/dl/h. A computer program randomized the allocation to the intervention and the concealment of the assignment was through sealed opaque envelopes. Bilirubin levels were taken at the start of phototherapy. Controls were at the beginning, every 8 hours and every 12 hours at the time of bilirubin stabilization in the case of hemolysis, or every 24 hours depending on risk factors. Axillary temperature was measured at the beginning of phototherapy, at 30 min, 60 min, 120 min and every 24 hours during intervention. Physical examination and daily water balance were performed. Parents and health personnel answered a survey on comfort and perceptions with the use of the devices at the end of phototherapy. Analysis: Comparison of means was made for the decrease of bilirubin levels and body temperatures and chi-square for incidence of side effects and results of the survey.

NCT ID: NCT03569254 Completed - Jaundice, Neonatal Clinical Trials

Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice

LEDlightT2
Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy to which a LED light mesh has been incorporated(a blanket), comparing it with the Ohmeda BiliBlanket Plus®. Methods: randomized controlled clinical trial with preterm or low birth weight infants requiring phototherapy. The study protocol was evaluated and accepted by the San Ignacio Hospital and "Pontificia Universidad Javeriana" research committee. Informed consent was requested from parents and the authors declared no conflict of interest. Sample size and allocation: using the STATA 12 program, a sample size of 64 patients was calculated(5% losses), 32 for each group, with significance level of 0.05, power of 80% and difference in bilirubin decreasing of at least 0,1 mg/dl/h with standard deviation of 0.14 mg/dl/h. A computer program randomized the allocation to the intervention and the concealment of the assignment was through sealed opaque envelopes. Seric bilirubin levels were taken at the start and at the end of phototherapy. Controls were done every 2 hours with the Bilicheck spectrophotometer device. Axillary temperature was measured at the beginning of phototherapy, at 30 min, 60 min, and every 2 hours during intervention. Physical examination and recording of side effects related were performed. Parents and health personnel answered a survey on comfort and perceptions with the use of the devices at the end of phototherapy. Analysis: Comparison of means was made for the decrease of bilirubin levels and body temperatures and chi-square for incidence of side effects and results of the survey.

NCT ID: NCT03527875 Not yet recruiting - Clinical trials for Jaundice, Obstructive

Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice

Start date: August 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).

NCT ID: NCT03510936 Recruiting - Clinical trials for Gastrointestinal Microbiome

Gut Microbiome Associated Study of Shanghai Infants With Jaundice

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.

NCT ID: NCT03510754 Completed - Pancreatic Cancer Clinical Trials

Endoscopic Ultrasound-guided Biliary Drainage for Malignant Biliary Obstruction After Failed ERCP

(EUS-BD)
Start date: January 1, 2011
Phase:
Study type: Observational

In this study the investigators retrospectively report outcomes of direct transluminal EUS-BD in a series of patients with malignant biliary obstruction after failed ERCP as the experience of a single Italian center

NCT ID: NCT03494023 Completed - Pancreatic Cancer Clinical Trials

EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice

ECCO
Start date: March 27, 2018
Phase:
Study type: Observational

The main objective of the study is to evaluate the size of the common bile duct (CBD) in a large cohort of patients with jaundice secondary to pancreatic head or distal bile duct malignancy undergoing diagnostic EUS for tissue acquisition or evaluation of resectability and to establish factors associated with a dilation of the CBD greater than 15mm.

NCT ID: NCT03491254 Not yet recruiting - Clinical trials for Obstructive Jaundice

Investigating the Efficacy and Safety of the Combination Treatment of Huaier Granule and Biliary Drainage for MOJ

Start date: May 30, 2018
Phase:
Study type: Observational

This study is designed to evaluate the efficacy and safety of the combination treatment of Huaier granule and biliary drainage for malignant obstructive jaundice.

NCT ID: NCT03418935 Completed - Clinical trials for Jaundice, Obstructive

Remaxol® in Mechanical Jaundice of Non-malignant Origin

Start date: April 3, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety and efficacy of Remaxol (succinate + methionine + inosine + nicotinamide; POLYSAN Ltd., Russia) infusions at dose 400 and 800 ml to treat mechanical jaundice of non-tumor cause during the first week after surgery.