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Jaundice, Neonatal 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: NCT06276582 Recruiting - Jaundice, Neonatal Clinical Trials

Screening for Neonatal Jaundice With a Mobile Health Device: a Validation Study in Oaxaca, Mexico.

Start date: January 17, 2023
Phase: N/A
Study type: Interventional

The performance and accuracy of the smartphone application (app) Picterus Jaundice Pro (PicterusJP) will be validated by a cross-sectional study conducted in low resource settings in Mexico. Physics-based and machine learning-based models will be used to analyze the images obtained with the app and its performance will be compared.

NCT ID: NCT06209489 Recruiting - Clinical trials for Hyperbilirubinemia, Neonatal

White Cover and Massage Impact on Bilirubin Levels and Phototherapy Duration in Newborns

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

This study aimed to examine the effect of white cover and massage application on newborns' bilirubin level and duration of phototherapy in newborns receiving 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: NCT06058910 Recruiting - Neonatal Screening Clinical Trials

Bilistick Point-of-care System 2.0 Bilirubin Validation

Start date: February 1, 2024
Phase:
Study type: Observational

This is a validation study involving the Bilistick System 2.0 point-of-care bilirubin measuring device. The validation will be conducted by comparing bilirubin measurements utilizing the standard-of-care blood sample collected for both a diagnostic reference device and Bilistick System 2.0 point-of-care device. Whole blood samples collected from male or female newborns (<2-weeks of age) born at a Kettering Health Network facility to obtain a total of 80 valid comparison pairs between the reference device and the Bilistick System 2.0 point-of-care device with current laboratory standards.

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.