Clinical trials: Hyperbilirubinemia, Neonatal
Neonatal Jaundice, Neonatal Hyperbilirubinemia
Evaluation of Bilirubin Estimates in Newborns From Smartphone Digital Images in a Population in Botswana
This project aims to test a novel smartphone application, Picterus, which provides a cheaper, patient-friendly, and more readily means of neonatal jaundice detection.
- Trial name
- BILIAPPBOT (NCT06399146)
- Testing
- Picterus App
- Where
- Botswana
- Volunteers
- 150 people
- Sponsor
- Hillerod Hospital, Denmark
Procedural Pain, Neonatal Hyperbilirubinemia
The Effect of Kangaroo Care on Pain in Infants Receiving Phototherapy
This study aims to evaluate and compare the effects of two different kangaroo care (KC) models on pain management in neonates undergoing phototherapy.
- Trial name
- NCT07761689
- Testing
- Kangaroo Care, Routine Care
- Where
- Turkey (Türkiye)
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Marmara University
Neonatal Hyperbilirubinemia
Neonatal Hyperbilirubinaemia in the Democratic Republic of Congo
Neonatal hyperbilirubinaemia (NH) is common among healthy neonates and normally resolves within a week. Untreated pathological hyperbilirubinaemia, however, can result in long-term neurological sequelae, which compromise…
- Trial name
- NCT03880591
- Where
- Democratic Republic of the Congo
- Volunteers
- 306 people, healthy volunteers welcome
- Sponsor
- University of Oxford
Neonatal Jaundice
Comparison of the Efficacy of Phototherapy Using Blue LED's With Wavelength 478 vs. 459 nm.
Treatment of neonatal jaundice is phototherapy with blue light at wavelength about 460 nm and irradiance > 30 uw/cm2/nm. Though, recent in vitro models have suggested that a wavelength of 478 nm should be optimal in reducing…
- Trial name
- NCT03183986
- Testing
- Phototherapy
- Where
- Denmark
- Volunteers
- 100 people
- Sponsor
- University of Aarhus
Hyperbilirubinemia, Neonatal
Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants
Thirteen hospitals in China will participate in the study, which aims to provide data on transcutaneous bilirubin (TcB) levels for the first 168 hr after birth in term and late-preterm neonates, and develop an hour-specific TcB…
- Trial name
- NCT01763632
- Testing
- Transcutaneous bilirubinometry
- Where
- 16 sites in China
- Volunteers
- 19,601 people, healthy volunteers welcome
- Sponsor
- Nanjing Medical University
Jaundice, Neonatal, Hyperbilirubinemia, Neonatal
Identification of Jaundice in Newborns Using Smartphones
Neonatal jaundice is a common and most often harmless condition. However, when unrecognized it can be fatal or cause serious brain injury. Three quarters of these deaths are estimated to occur in the poorest regions of the world.
- Trial name
- NCT04182555
- Testing
- Bilirubin estimates from Smartphone Application, Bilirubin concentration measured in standard blood samples, Bilirubin estimates from standard transcutaneous device
- Where
- 2 sites in Norway
- Volunteers
- 220 people
- Sponsor
- St. Olavs Hospital
Jaundice, Neonatal
Treatment of Neonatal Jaundice With Filtered Sunlight Phototherapy: Safety and Efficacy in African Neonates
The primary objective of this study is to determine the safety and efficacy of filtered sunlight phototherapy. Sunlight will be filtered by flexible (window-tinting) film.
- Trial name
- NCT01434810
- Testing
- Filtered-sunlight phototherapy, Conventional phototherapy
- Where
- Nigeria
- Volunteers
- 447 people, healthy volunteers welcome
- Sponsor
- University of Minnesota
Genetic/Metabolic Liver Diseases
China Registry for Genetic / Metabolic Liver Diseases
CR-GMLD registry started on June 13, 2015 to collect cases of genetic/metabolic liver diseases from tertiary or secondary hospitals in mainland China.
- Trial name
- NCT03131427
- Testing
- Standard of care
- Where
- 12 sites in China
- Volunteers
- 20,000 people
- Sponsor
- Beijing Friendship Hospital
Jaundice, Neonatal, Phototherapy
Effectiveness, Safety and Perceptions With the Use of One LED Blanket Device in the Ambulatory Treatment of Jaundice
Objective: to evaluate the effectiveness, safety and level of satisfaction of parents and healthcare team with one innovative device for phototherapy to which a LED light mesh has been incorporated(a blanket), comparing it with…
- Trial name
- LEDlightT2 (NCT03569254)
- Testing
- Neomedlight Phototherapy Blanket, Ohmeda-Fiber Optic Phototherapy Blanket
- Where
- Colombia
- Volunteers
- 64 people
- Sponsor
- Nathalie Charpak
Nutritional and Metabolic Diseases
Efficacy and Safety of Stannsoporfin in Neonates
This is a multi-center, randomized, sham injection-controlled (placebo) masked trial of a single intramuscular injection of Stannsoporfin compared to "sham" (placebo) in healthy term and near-term newborns admitted to the…
- Trial name
- NCT02685137
- Testing
- stannsoporfin
- Where
- United States
- Volunteers
- 185 people
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
Neonatal Jaundice
NeoSCB App for Screening Jaundice in Newborns
About 60% of babies born after 36 weeks of pregnancy have jaundice during the first two weeks of life. Due to the accumulation of bilirubin in the bloodstream, jaundiced babies appear yellow, which allows healthcare professionals…
- Trial name
- neoSCB (NCT06963450)
- Testing
- Taking photos of a baby's eye
- Where
- United Kingdom
- Volunteers
- 405 people, healthy volunteers welcome
- Sponsor
- University College, London
Neonatal Jaundice, Hyperbilirubinemia
Transcutaneous Screening for Risk of Severe Hyperbilirubinemia in South African Newborns
In South Africa, healthy term newborns are usually discharged early (<72 hours after delivery). Many studies have shown that hospital readmission rates have increased with this practice, and jaundice or hyperbilirubinemia is the…
- Trial name
- NCT02613676
- Testing
- Transcutaneous bilirubin screening, Standard care (Visual inspection)
- Where
- South Africa
- Volunteers
- 1,858 people, healthy volunteers welcome
- Sponsor
- University of Stellenbosch
Jaundice, Neonatal
Comparison Of Fenofibrate Vs Phenobarbitone As Adjunct To Phototherapy In Reducing Total Serum Bilirubin In Indirect Hyperbilirubinemia In Neonates
This is a prospective, randomized, open-label controlled trial comparing fenofibrate (10 mg/kg) and phenobarbitone (3 mg/kg) as adjuncts to conventional phototherapy in neonates with unconjugated hyperbilirubinemia.
- Trial name
- NCT07774741
- Testing
- Fenofibrate + Phototherapy, Phenobarbitone + Phototherapy
- Volunteers
- 70 people
- Sponsor
- Rubab Fatima
Crigler-Najjar Syndrome Type I
Gene Therapy for Crigler Najjar Syndrome Type I (AlphaCN)
This is a Phase 1/2, multinational, open-label, study to evaluate the safety and efficacy of an intravenous infusion of GT-UGT1A1-AAV8-02 in patients with Crigler-Najjar type 1 aged ≤10 years and requiring phototherapy.
- Trial name
- NCT06641154
- Testing
- GT-UGT1A1-AAV8-02
- Where
- 2 sites in Russia
- Volunteers
- 5 people
- Sponsor
- Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare
Gilbert Syndrome
Brown Adipose Tissue Activity in Gilbert's Syndrome
The goal of this case-control study is to investigate energy metabolism and brown adipose tissue (BAT) activity in individuals with Gilbert's syndrome (GS) and controls. The main focus of the study is to analyze: 1.
- Trial name
- NCT06336369
- Testing
- analyzing brown adipose tissue, body composition and metabolic health
- Where
- Austria
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Hyperbilirubinemia
Light-emitting Diodes (LED) Phototherapy for Hyperbilirubinemia of Term Newborn
Phototherapy is almost (beside exchange transfusion) the unique treatment for hyperbilirubinemia of the newborn. Its efficacy to decrease bilirubin level (because the light interacts with bilirubin at the skin level to transform…
- Trial name
- DELF (NCT01136577)
- Testing
- Phototherapy
- Where
- France
- Volunteers
- 44 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Crigler-Najjar Syndrome
Gene Transfer Clinical Study in Crigler-Najjar Syndrome
This is a Phase 1/2, multinational, open-label, ascending-dose, delayed-treatment concurrent control clinical study to evaluate the safety and preliminary efficacy of AT342 in subjects with Crigler-Najjar aged ≥1 year.
- Trial name
- VALENS (NCT03223194)
- Testing
- AT342
- Where
- 4 sites in United States, Israel and 1 more
- Volunteers
- 1 people
- Sponsor
- Audentes Therapeutics
Hyperbilirubinemia, Neonatal
Prediction of Neonatal Hyperbilirubinemia
Objective: To develop an evidence-based strategy for assessing the risk of significant hyperbilirubinemia in healthy term and near-term (late-preterm) neonates.
- Trial name
- 2010ICTPAGR (NCT01109277)
- Where
- Greece
- Volunteers
- 3,500 people
- Sponsor
- University of Patras
Jaundice, Neonatal
The Effectiveness of Probiotics in Neonatal Jaundice
Hyperbilirubinemia is a prevalent problem in babies that necessitates medical attention. Probiotic administration as adjuvant therapy may have a positive impact on the pathological neonatal unconjugated hyperbilirubinemia.
- Trial name
- NCT06449508
- Testing
- Probiotic Formula
- Volunteers
- 44 people
- Sponsor
- Tanta University
Jaundice, Neonatal
Transcutaneous Bilirubin Measurements in Neonates Post Phototherapy
Can transcutaneous bilirubin (TcB) measurements be utilised to assess rebound hyperbilirubinaemia following phototherapy in neonates?
- Trial name
- NCT04719104
- Testing
- Transcutaneous Bilirubin Meter - 'Bilimeter'
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- NHS Greater Glasgow and Clyde