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Jaundice, Neonatal clinical trials

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NCT ID: NCT06346743 Not yet recruiting - Clinical trials for Physiological Neonatal Jaundice

Comparison of Effects of Fenofibrate Adjuvant Therapy Versus Conventional Phototherapy in Neonatal Jaundice.

Start date: April 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Neonatal jaundice has significant importance in neonatal morbidity and mortality world-wide. Though phototherapy has a relentless use in neonatal jaundice, its cumbersome side effects and the physical separation of baby from the mother eventually result as increase in days of hospitalization adding to the mental anguish of the parents. This study is conducted to observe the reduction of serum bilirubin level in neonates treated with Fenofibrate as an adjuvant to phototherapy in treatment of exaggerated physiological hyperbilirubinemia. After informed consent, single dose of Fenofibrate will be given to the group A (intervention group) and Group B (non-intervention) will only be given phototherapy. Then every 24-hourly sample for serum bilirubin will be sent for lab analysis, for 3 days. A randomized control trial is conducted and later on, the data will be analyzed in the SPSS 26. Quantitative variables like age will be presented as mean ± SD. Qualitative variables like gender will be presented as percentage and frequency. Comparison of two groups intervention group and non-intervention group, apply independent sample t-test. P value < 0.05 will be taken as significant. Limitation of the proposed study includes limited sample size, study population limited to only one hospital and no follow-up in plan. If the role of Fenofibrate is established in the management of exaggerated physiological hyperbilirubinemia in newborns, it will be beneficial to minimize the risk of the complications, rapid regression of hyperbilirubinemia & shortening the length of hospital stay.

NCT ID: NCT06087874 Not yet recruiting - Pregnancy Related Clinical Trials

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

Start date: January 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: NCT06080971 Not yet recruiting - Neonatal Jaundice Clinical Trials

Persistent Neonatal Jaundice on Neonates and Childern

Start date: October 13, 2023
Phase:
Study type: Observational

Describe demographic and clinical data of neonates & childern with (PNNJ) admitted to neonatology , hepatology & hematology units of Assiut university children hospital(AUCH). Describe the distribution of etiologies of (PNNG) in neonates & children at AUCH. Assess the outcome of (PNNJ) in neonates & childern admitted to AUCH .

NCT ID: NCT05964426 Not yet recruiting - Clinical trials for Unspecified Fetal and Neonatal Jaundice

Health Literacy of Parents Regarding Neonatal Jaundice

Start date: August 1, 2023
Phase:
Study type: Observational

This study will be conducted as a relational descriptive study to determine the health literacy level of parents with infants between 0-28 days of age regarding neonatal jaundice. The secondary aim of the study is to examine whether the health literacy levels of the parents differ with parent and infant descriptive characteristics and their knowledge about neonatal jaundice. In this study, answers to the following questions were sought. 1. What is the level of knowledge about neonatal jaundice among parents with infants between 0-28 days? 2. What is the level of health literacy of parents with infants between 0-28 days of age and is there a relationship between parent, infant identifying characteristics and knowledge about neonatal jaundice?

NCT ID: NCT05806684 Not yet recruiting - Premature Clinical Trials

Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.

biliROP
Start date: May 1, 2023
Phase:
Study type: Observational

The goal of this retrospective observational study is to [learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants. The main question it aims to answer are: • To evaluate the possible effect of neonatal jaundice linked to the presumed protective antioxidant action of bilirubin on the development of ROP, compared to a control group which, although presenting ROP, did not develop jaundice.

NCT ID: NCT05510518 Not yet recruiting - Obesity Clinical Trials

Late Gestational Diabetes Mellitus Diagnosis in Obese Women

Start date: August 2022
Phase:
Study type: Observational

In the current work, we aim to perform a prospective study that will investigate the relationship between maternal obesity (BMI >30 kg/m2) and morbid obesity (BMI >35 kg/m2) with a late GDM diagnosis (>32 weeks), with an emphasis on obstetric and neonatal outcomes.

NCT ID: NCT05475223 Not yet recruiting - Neonatal Jaundice Clinical Trials

End Tidal Carbon Monoxide (ETCO): - A Tool to Aid Identification of Neonatal Hemolysis

Start date: July 29, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate if adding a noninvasive testing of End Tidal Carbon Monoxide with a FDA approved device will help improve management of jaundice in the Neonates by reducing the number of lab draws, Coombs tests and optimizing the number of phototherapy hours in Neonates who need it. Eligible subjects will be Term and healthy late preterm newborns born at Cedars-Sinai Medical Center and admitted to well baby nursery from November 2020 onwards. The primary procedure of measuring an End-Tidal Carbon monoxide in a Newborn is going to be with a soft cannula applied to the Newborn's nose for a few minutes. The whole procedure will take about 15+ 5 minutes. Subject participation will last approximately 6 months and all subjects will be followed up with one phone call at about 2-4 weeks of age. Adding ETCO testing to current standard of care might reduce the number of lab draws in a newborn and potentially reduce costs by optimizing the number of phototherapy hours in a Newborn who needs it. Cedars- Sinai Medical Center will not be billing the patients for the End-Tidal Carbon Monoxide measurement for this study.

NCT ID: NCT05365984 Not yet recruiting - Clinical trials for Hyperbilirubinemia, Neonatal

Intelligent Follow-up of Neonatal Jaundice Based on Early Indicators and Internet Communications

Start date: May 2022
Phase: N/A
Study type: Interventional

In this prospective multi-center randomized clinical trial, a new follow-up strategy for neonatal jaundice after discharge will be evaluated. It is based on current risk factors of neonatal hyperbilirubinemia, added with the rate of bilirubin production (exhaled carbon monoxide measurement) as a new indicator,and incorporated with Internet Plus technology. Traditional methods following the Chinese guideline for neonatal hyperbilirubinemia were applied in the control group. The morbidity of BIND, the number of outpatient follow-up after discharge and the convenience will be compared between the two groups. The accuracy, effectiveness, safety and convenience of the study strategy will be testified.

NCT ID: NCT05178433 Not yet recruiting - Atopic Dermatitis Clinical Trials

Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants

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

Atopic Dermatitis (AD) is a common chronic, recurrent, and inflammatory skin disease in children. The incidence of moderate to severe AD in infants aged 1-12 months in our country is as high as 25.41%, which is related to subsequent allergic diseases and affects Children's emotions and growth. There are limited drugs that can be used for infant AD. The current guidelines recommend early use of functional skin care products to prevent and treat AD by repairing the skin barrier, moisturizing, and anti-inflammatory. Neonatal jaundice is one of the most common neonatal diseases. 20% of children with jaundice need phototherapy. It is a simple and effective method for jaundice. Studies have found that phototherapy can convert Th2 to Th1, leading to an imbalance of pro-inflammatory and anti-inflammatory, which induces allergies. We speculate that it is of great value to take protective measures such as skin moisturizing during phototherapy for jaundice in children at high risk of allergies. This project intends to take the lead in conducting a randomized controlled study on the use of baby moisturizing products during neonatal phototherapy. Through evaluation projects such as skin microecology analysis, serum allergy indicators and AD clinical manifestations, it is verified that the use of functional skin care products in phototherapy of newborns with high allergies can delay and reduce the severity of AD in infants.

NCT ID: NCT04719104 Not yet recruiting - Jaundice, Neonatal Clinical Trials

Transcutaneous Bilirubin Measurements in Neonates Post Phototherapy

Start date: April 2021
Phase: N/A
Study type: Interventional

Can transcutaneous bilirubin (TcB) measurements be utilised to assess rebound hyperbilirubinaemia following phototherapy in neonates?