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Hyperbilirubinemia 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: 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: 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: NCT04868019 Not yet recruiting - Clinical trials for Hyperbilirubinemia, Neonatal

Role of Fenofibrate in Indirect Neonatal Hyperbilirubinemia: a Randomized Control Trial

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

Fenofibrate accelerates bilirubin conjugation and excretion, decreasing the side effects of prolonged unconjugated hyperbilirubinemia in neonates. It also reduces the duration of phototherapy and thus the duration of stay in the hospital. This research is carried out to improve standard protocol for the management of neonatal hyperbilirubinemia in the local settings.

NCT ID: NCT04585828 Not yet recruiting - Clinical trials for Neonatal Hyperbilirubinemia

Comparison of Double Pad Fiber Optic Device Versus Conventional Phototherapy

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

A randomized study of phototherapy for neonatal hyperbilirubinemia. The intervention group is treated with a double pad fiber optic device and the control group with conventional blue ligt phototherapy from above. Both treatments are well known and used. The primary outcome is to explore the parents experience with the two different treatment modalities by questionnaires.

NCT ID: NCT04445675 Not yet recruiting - Jaundice, Neonatal Clinical Trials

The Effect of Breastfeeding Support on Hospitalization Due to Jaundice

Breastfeeding
Start date: August 1, 2020
Phase: N/A
Study type: Interventional

Neonatal jaundice is the most common reason for rehospitalization after postnatal discharge. Jaundice due to breastfeeding failure is an important subtype of pathological neonatal jaundice. Typically, it occurs with lactation failure, which results in dehydration (reducing urine output), significant weight loss (>10% of birth weight) and sometimes hypernatremia, during the first postnatal week. Jaundice caused by breastfeeding failure is observed in one third (31.8%) of total cases of pathological neonatal jaundice requiring rehospitalization. Jaundice lasts for an average of 6.8 days and the length of hospital stay takes up to 3 days. Jaundice due to breastfeeding failure requires focused efforts for a program structured with breastfeeding education and special breastfeeding support. This support causes the role of nurses to become even more important. The aim of this study is to investigate the effect of support provided for breastfeeding and the feeding of infants' with breast milk on hospitalization due to jaundice. Research Hypotheses: H0: The support provided for breastfeeding and the feeding of infants' with breast milk has no effect on hospitalization due to jaundice. H1: The support provided for breastfeeding and the feeding of infants' with breast milk affects the consequences of hospitalization due to jaundice.

NCT ID: NCT04246229 Not yet recruiting - Clinical trials for Neonatal Hyperbilirubinemia

Transcutaneous Bilirubinometry and Phototherapy

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

A randomized Controlled trial comparing the use of transcutaneous bilirubinometry to serum bilirubin measurements (via blooddraws = standard care) in neonates born after a gestational age > 32 weeks and < 15 days of age treated with Phototherapy for neonatal hyperbilrubinemia. Main outcome measurement is the number of blooddraws for measurement of bilirubin. Secondary outcome measurements are duration of phototherapy and hospitalisation.

NCT ID: NCT03684499 Not yet recruiting - Bilirubinemia Clinical Trials

Fluid in Neonatal Hyperbilirubinemia

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

Hyperbilirubinemia is a common neonatal problem. bilirubin is potentially toxic to central nervous system and can cause serious permanent complication called kernicterus, in which brain stem nuclei and basal ganglia are damaged,resulting in cerebral palsy.In Hyperbiliubinemia,rapid reduction of serum bilirubin level is of utmost importance. Two commonly used mode of therapy are phototherapy and exchange transfusion. Phototherapy has some side effects such as diarrhea, skin rash, dehydration, overheating, mother-baby bonding disruption.On the other hand, complication of exchange transfusion include infections, emboli,anemia,apnea and hypocalcemia. while IV fluid supplementationis postulated to decrease bilirubin concentration directly through a reduction of haemoconcentration, increasing enteral feed volume is proposed to decrease bilirubin concentration through reduced enterohepatic circulation via an increased gut peristalsis.