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Jaundice, Neonatal clinical trials

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NCT ID: NCT05521607 Recruiting - Neonatal Jaundice Clinical Trials

Evaluation of a Smartphone-based Screening Tool (Picterus JP) for Neonatal Jaundice (Chicago)

Start date: January 6, 2023
Phase: N/A
Study type: Interventional

A cross-sectional conductive study at the University of Chicago Medicine facilities (hospital and outreach clinics) to enable high qualitative estimation of bilirubin levels in the blood of newborns, independent of skin color, using Picterus JP.

NCT ID: NCT05282394 Recruiting - Newborn Jaundice Clinical Trials

Newborn Abdominal Massage to Prevent Hyperbilirubinemia

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The proposed study will incorporate an intervention previously un-studied in the US healthcare setting for prevention of hyperbilirubinemia

NCT ID: NCT05257369 Recruiting - Clinical trials for Neonatal Hyperbilirubinemia

Broad Band Emission LED Phototherapy Source Versus Narrow Band

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Phototherapy is the most frequently used treatment in neonatology when serum bilirubin levels exceed physiological limits. Light-emitting diodes (LEDs) are become routinely used for phototherapy in neonates with hyperbilirubinemia. Blue LED light with peak emission around 460 nm is regarded as the most suitable light sources for phototherapy and they recommended by most neonatal guidelines. However, the effectiveness of phototherapy with narrow-band LED light sources can be increased by expanding the spectral range of incident radiation within the absorption of bilirubin due to the strongly marked heterogeneity absorption properties of bilirubin in a different microenvironment. Longer wavelength light, such as green light, is expected to penetrate the infant's skin deeper. It is still controversial whether the use of green light has any advantage over blue light. The most effective and safest light source and the optimal method to evaluate phototherapy, however, remain unknown.The aim of this study was to compare, at equal light irradiance, the clinical efficacy of broad spectrum blue- green LED with blue narrow spectral band phototherapy device.

NCT ID: NCT05127070 Recruiting - Prematurity Clinical Trials

Evaluating the NeoTree in Malawi and Zimbabwe

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

Neonatal mortality remains unacceptably high. Globally, the majority of mothers now deliver in health facilities in low resource settings where quality of newborn care is poor. Health systems strengthening through digitial quality improvement systems, such as the Neotree, are a potential solution. The overarching aim of this study is to complete the co-development of NeoTree-gamma with key functionalities configured, operationalised, tested and ready for large scale roll out across low resource settings. Specific study objectives are as follows: 1. To further develop and test the NeoTree at tertiary facilities in Malawi and Zimbabwe 2. To investigate HCPs and parent/carer view of the NeoTree, including how acceptable and usable HCWs find the app, and potential barriers and enablers to implementing/using it in practice. 3. To collect outcome data for newborns from representative sites where NeoTree is not implemented. 4. To test the clinical validity of key NeoTree diagnostic algorithms, e.g. neonatal sepsis and hypoxic ischaemic encephalopathy (HIE) against gold standard or best available standard diagnoses. 5. To add dashboards and data linkage to the functionality of the NeoTree 6. To develop and test proof of concept for communicating daily electronic medical records (EMR) using NeoTree 7. To initiate a multi-country network of newborn health care workers, policy makers and academics. 8. To estimate cost of implementing NeoTree at all sites and potential costs at scale

NCT ID: NCT04369313 Recruiting - Clinical trials for Gestational Diabetes Mellitus

Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers

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

Evidence for benefited newborns following delayed cord clamping (DCC), including increasing hemoglobin and hematocrit levels, improving iron stores, and decreasing need for blood transfusion and incidence of intraventricular hemorrhage, in term or preterm infants led the American College of Obstetricians and Gynecologists (ACOG) to recommend a delayed cord clamping at least 30-60 seconds in vigorous term and preterm infants at birth. Although DCC has been found to be beneficial to infants, the additional blood provided by DCC could increase the incidence of jaundice that requires phototherapy and the hyperbilirubinemia, and the time prolonged by DCC might jeopardize timely resuscitation efforts, if needed. The acid-base status in umbilical cord blood at birth reflects the newborn's aerobic and anaerobic intrauterine metabolisms and is an objective measure of the fetal exposure and response to hypoxia during labour. Gestational diabetes mellitus (GDM) is a condition in which glucose intolerance develops during pregnancy. It has been estimated in 2009 that nearly 7% of pregnancies are complicated by diabetes and approximately 86% of these cases represented women with GDM. The Hyperglycemia and Adverse Pregnancy Outcome study (HAPO) revealed that the infants of diabetic mothers (IDMs) are at increased risk of neonatal hypoglycemia, hyperbilirubinemia, shoulder dystocia, and birth trauma. And newborns to diabetic mothers are at increased risk of neonatal respiratory distress syndrome (RDS) and hypoxia, a major cause of admission in neonatal intensive care units. There is little direct evidence on the implementation of delayed umbilical cord clamping in the risk group of IDMs. Therefore, it no clear that the effectiveness and impairment of DCC in IDMs. Therefore, the investigators conducted a prospective study in performing DCC in the infants of diabetic mothers versus the newborns with early cord clamping (ECC) to assess the effect of DCC on neonatal bilirubin levels, hyperbilirubinemia incidence, acid-base status and hypoxia in IDMs.

NCT ID: NCT04365998 Recruiting - Neonatal Jaundice Clinical Trials

BUBOLight®, a New Phototherapy Device for the Treatment of the Newborn's Jaundice

BUBO
Start date: October 8, 2020
Phase: N/A
Study type: Interventional

About 50% of full-term newborns and 80% of premature infants develop jaundice which is due to hyperbilirubinemia. In the majority of cases, jaundice disappears naturally without treatment within three weeks of birth, but the bilirubin level may remain too high, which can lead to a serious neurological disease: kernicterus. To avoid this, a therapeutic management must be instituted, and in some cases, one or more phototherapy sessions (PT) may be prescribed. The aim of this trial is to evaluate the safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy BUBOLight® included two removable strips of luminous textile incorporating optical fibers. 10 newborns requiring phototherapy, will be illuminated during four hours in one session of PT Bilirubin levels is taken at the start of phototherapy H0 and Controls are made at H+6 hours.

NCT ID: NCT04251286 Recruiting - Clinical trials for Hyperbilirubinemia, Neonatal

Screening and Follow-up Study of Neonatal Jaundice Based on Mobile Network

Start date: May 1, 2020
Phase:
Study type: Observational [Patient Registry]

At least 13 hospitals in China will participate in the study, which aims to clarify the natural history of jaundice in Chinese healthy newborns,and decrease the incidence of severe hyperbilirubinemia and acute bilirubin encephalopathy and even kernicterus. The study is an open project, and the investigators welcome institutions fulfilling the specified requirements to join the study during the recruitment phase.

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: NCT03237715 Recruiting - Neonatal Jaundice Clinical Trials

Unbound Bilirubin Levels in Healthy Term and Late Preterm Infants

Start date: July 1, 2017
Phase: N/A
Study type: Observational

Specific Aim 1: To determine total serum bilirubin (TSB) and unbound bilirubin (Bf) levels in term and late preterm infants during the first week of life. Specific Aim 2: Measure Bf levels in breast fed and formula fed infants and examine their relationship to unbound fatty acid (FFAu) levels. Specific Aim 3: To demonstrate that phototherapy results in different changes in TSB and Bf.