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Jaundice, Neonatal clinical trials

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NCT ID: NCT03942757 Completed - Preterm Infant Clinical Trials

BiLirubin Decrease Under Phototherapy Exposure in the Preterm Newborn in Incubator

BLUE
Start date: May 2, 2019
Phase:
Study type: Observational [Patient Registry]

Phototherapy is routinely used in neonatal intensive care units for the treatment of jaundice. Guidelines focus mainly on bilirubin serum levels to start the phototherapy. Only few data are available about clinical management of phototherapy devices and subsequently the impact on bilirubin serum decrease. Especially there are no strong recommendations about phototherapy duration, irradiance measurements, incubator temperature and humidity settings. Various factors can influence irradiance and thus the preterm infant bilirubin serum decrease. This study aims at evaluating the impact of an educational program on the use and efficacy of phototherapy in a neonatal intensive care unit.

NCT ID: NCT03933423 Recruiting - Neonatal Jaundice Clinical Trials

Home Based Phototherapy for Neonatal Jaundice

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The main purpose of the study is to deliver community health worker based prevention, early screening and management of neonatal Jaundice using battery powered LED phototherapy device at the household level.

NCT ID: NCT03866213 Recruiting - Jaundice, Neonatal Clinical Trials

Validation of a Jaundice Diagnostic and Monitoring Device for Low-Resource Settings

Start date: August 1, 2019
Phase:
Study type: Observational

A team of researchers at Rice University in partnership with clinicians at Queen Elizabeth Central Hospital created BiliSpec, a low-cost battery-powered reader designed to immediately quantify serum bilirubin levels from a small drop of whole blood applied to a lateral flow strip. The simple and affordable BiliSpec system offers a faster and more cost-effective means to detect neonatal jaundice in under-resourced clinics and determine when phototherapy is needed. The goal of this study is to validate the accuracy of the BiliSpec device in measuring bilirubin levels in neonates relative to the laboratory spectrophotometric bilirubinometer and transcutaneous bilirubinometer measurements.

NCT ID: NCT03805165 Enrolling by invitation - Jaundice, Neonatal Clinical Trials

Hour-specific Transcutaneous Bilirubin in Healthy Term and Near-term Newborns of China

Start date: February 1, 2019
Phase:
Study type: Observational

Make a neonatal jaundiced nomogram on Chinese jaundice data by joinning the major neonate centers all around China.

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: NCT03306004 Completed - Neonatal Jaundice Clinical Trials

Neonatal Jaundice: Knowledge, Attitudes and Practices of Mothers and Medical Trainees and Providers in and Around Ogbomosho

4NNJ
Start date: November 2016
Phase: N/A
Study type: Observational

Determine the knowledge attitude and practices of all levels of health care providers about neonatal jaundice

NCT ID: NCT03246503 Completed - Newborn Jaundice Clinical Trials

BiliCam Clinical Validation Study

Start date: August 21, 2017
Phase:
Study type: Interventional

The goal of this study is to assess the accuracy of BiliCam, a non-invasive technology based on analysis of digital images obtained with an app installed on a commercial smartphone, in estimating total serum bilirubin levels in newborns. BiliCam estimated bilirubin levels will be compared to total serum bilirubin levels in up to 225 newborns.