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Neonatal Jaundice clinical trials

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NCT ID: NCT06399146 Recruiting - Neonatal Jaundice Clinical Trials

Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana

BILIAPPBOT
Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This project aims to test a novel smartphone application, Picterus, which provides a cheaper, patient-friendly, and more readily means of neonatal jaundice detection. For this purpose, the study aims to collect data from newborns with a broad range of bilirubin levels and high melanin content in a population in Botswana.

NCT ID: NCT06341582 Recruiting - Neonatal Jaundice Clinical Trials

Prediction and Evaluation by ETCOc of Neonatal Hyperbilirubinemia Cohort

PREVENT
Start date: December 11, 2023
Phase:
Study type: Observational [Patient Registry]

The hemolytic disease of newborns (HDN) is one of the most significant risk factors for hyperbilirubinemia. Studies have shown that end-tidal carbon monoxide-corrected (ETCOc) correlated with the rate of bilirubin production in the body and thus can be a good surrogate to quantify hemolysis and identifying the high-risk infants. However, there is insufficient clinical evidence regarding the early prediction of hemolytic hyperbilirubinemia using ETCOc. This study hypothesizes that early postnatal ETCOc levels are significantly associated with the risk of hemolytic hyperbilirubinemia requiring treatments within 14 days after birth, and early postnatal ETCOc can be a good indicator for early prediction of hemolysis. In addition, the investigators aim to investigate the relationship between the characteristics of treatments for hyperbilirubinemia and ETCOc.

NCT ID: NCT06329843 Recruiting - Neonatal Jaundice Clinical Trials

Intermountain Inpatient Bilirubin Decision Accuracy Study Using Smartphone-based Measurements by Picterus Jaundice Pro

Start date: February 12, 2024
Phase:
Study type: Observational

The goal of this project is to evaluate the performance of Picterus Jaundice Pro in an American population, including preterm and term newborns and pre- and post- phototherapy.

NCT ID: NCT06087874 Recruiting - Pregnancy Related Clinical Trials

Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice

Start date: March 23, 2024
Phase: Phase 2
Study type: Interventional

This is a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group) to investigate the effect of maternal perinatal probiotic supplementation on neonatal jaundice, breast milk microbiome, maternal stool, and infant fecal microbiome. Vivomixx®-probiotic product will be used as treatment and placebo as a control.

NCT ID: NCT06075290 Recruiting - Neonatal Jaundice Clinical Trials

the Difference of Follow-up Methods of Neonatal Jaundice

NJFU
Start date: October 10, 2023
Phase:
Study type: Observational

The goal of this observational study is to compare the effectiveness and efficiency for precaution of severe hyperbilirubinemia in neonate by different follow-up methods of neonatal jaundice. There are two kinds of follow-up methods in the investigators clinical practice. The one is internet plus follow-up model, the other is conventional clinic follow-up method. Parents of the participant neonates can choose one by themselves. After parents of the participant signed informed consent, the investigators recorded several information including severe hyperbilirubinemia, length of phototherapy, follow-up times, et al. Then the investigators analysed these data in order to know what kind of follow-up method is better to prevent severe hyperbilirubinemia and more easy to be accepted.

NCT ID: NCT06073444 Recruiting - Neonatal Jaundice Clinical Trials

mHealth to Screen for Neonatal Jaundice in Low-resource Mexican Settings: a Feasibility Study

JAUND-EASE
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Neonatal jaundice (NNJ) is a common condition in newborns during the first week of life due to increased levels of bilirubin. Usually, it resolves without consequences after 7 to 10 days. However, around 10% of the newborns develop a severe form, which if is not detected on time, can lead to irreversible consequences including brain damage, disabilities and even death. The goal of this study is to determine the feasibility of implementing a smartphone app (Picterus JP) to screen for NNJ in low resource health facilities in Mexico and to evaluate its potential effectiveness to detect severe cases of the condition compared to the current used method that consists in visual assessment (VA). Research questions are: 1. Is it feasible to implement the smartphone app Picterus JP to screen for NNJ in low resource health facilities in Mexico? 2. Will Picterus JP increase the detection of severe NNJ compared to VA? Participants will include: 1. Newborns who attend the health facilities for neonatal check up 2. Health care workers (HCWs) using the app 3. Parents of newborns screened with Picterus JP Methodology: Mothers will be asked to consent their newborn's participation. The newborns will be then randomly assigned to either: 1. control group in which jaundice will be screened by healthcare workers using VA or 2. intervention group in which jaundice will be screened using Picterus JP in addition to VA If the bilirubin measurement with Picterus is >15 mg/dl or there is suspicion of severe NNJ by VA, newborns will be referred to emergency room for further evaluation by a doctor and/or measure the level of bilirubin in blood. Researchers will compare the number of bilirubin blood levels >15 mg/dl between the two groups. HCWs and newborns' parents will be interviewed to identify their perceptions and experiences towards the use of the app.

NCT ID: NCT05955144 Recruiting - Neonatal Jaundice Clinical Trials

Clinical Validation of the Screening Tool Picterus JP Using Different Smartphones

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

The overall aim of this study is to verify the quality of our internal developed camera validation systems and allow the use of Picterus JP on all smartphones.

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: 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: 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.