Clinical trials: Cholestasis in Newborn
Cholestasis
Low Dose Fat for the Prevention of Liver Disease in Babies With Gastrointestinal Disorders
Neonates with congenital/acquired gastrointestinal disorders are at high risk for Parenteral Nutrition Associated Cholestasis (PNAC).
- Trial name
- NCT01373918
- Testing
- Intralipid
- Where
- 2 sites in United States
- Volunteers
- 41 people
- Sponsor
- University of California, Los Angeles
PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS)
Pediatric Evaluation and Registry for Liver Cholestasis in Canada
The purpose of this study is to create a national, multi-centre registry for children with Alagille syndrome (ALGS) and Genetic Intrahepatic Cholestasis (GIC) that follows participants long-term, ensuring standardized…
- Conditions
- PFIC - Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome (ALGS), Cholestasis, Intrahepatic
- Trial name
- PEARL (NCT07411716)
- Where
- 13 sites in Canada
- Volunteers
- 220 people
- Sponsor
- Children's Hospital of Eastern Ontario
Alagille Syndrome, Pulmonary Artery Stenoses
Decreasing Hemorrhage Risk in Children With Alagille Syndrome
The goal of this interventional study is to test a hemostasis screening protocol and cardiac peri-procedural and post-operative hemostasis pathway to improving bleeding complications and improve patient survival for children with…
- Conditions
- Alagille Syndrome, Pulmonary Artery Stenoses, Acquired Von Willebrand Disease
- Trial name
- NCT05846854
- Testing
- Assessment for bleeding disorder with tailored post-operative care
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Stanford University
Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth.
- Trial name
- CHOLE-RESP (NCT06679972)
- Where
- Romania
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Carol Davila University of Medicine and Pharmacy
Dental Diseases
Dental Dyschromia and Quality of Life in Early Prolonged Hyperbilirubinemia
The main objective of this study is to assess the prevalence of dental discoloration (dental dyschromia) in children who experienced high levels of bilirubin in their blood (hyperbilirubinemia) during their early years.
- Trial name
- SMILE (NCT06506734)
- Testing
- Questionnaires
- Where
- 9 sites in France
- Volunteers
- 120 people
- Sponsor
- University Hospital, Toulouse
Biliary Atresia, Intrahepatic Cholestases
Intestinal Microbiome Composition in Infants With Biliary Atresia (BA)
A prospective observational study in infants with biliary atresia and controls to determine whether the composition of the intestinal microbiome is specific for biliary atresia will be conducted.
- Conditions
- Biliary Atresia, Intrahepatic Cholestases, Normal Controls
- Trial name
- BA (NCT03890536)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Biliary Atresia
Biliary Atresia Study in Infants and Children
Little is known about the factors that cause biliary atresia nor the factors that influence disease progression. The purpose of this study is to collect the pertinent clinical information, genetic material and body fluid samples…
- Trial name
- BASIC (NCT00345553)
- Where
- 16 sites in United States, Canada
- Volunteers
- 1,265 people
- Sponsor
- Arbor Research Collaborative for Health
Hepatobiliary Disease, Biliary Atresia
Dry Blood Spot Screening Test for Biliary Atresia（DBS-SCReBA）
Our study aims to develop a screening test for biliary atresia (BA) using dry blood spot to improve patient survival by early diagnosis.
- Conditions
- Hepatobiliary Disease, Biliary Atresia, Neonatal Cholestasis
- Trial name
- NCT03898765
- Testing
- Dry blood spot screening
- Where
- China
- Sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Infantile Refsum's Disease, Zellweger Syndrome
Compassionate Treatment of Patients With Inborn Errors of Bile Acid Metabolism With Cholic Acid
OBJECTIVES: I. To Evaluate the therapeutic efficacy of cholic acid during provision of compassionate treatment to patients with identified inborn errors of bile acid synthesis and metabolism II.
- Conditions
- Infantile Refsum's Disease, Zellweger Syndrome, Adrenoleukodystrophy, Peroxisomal Disorders
- Trial name
- NCT00007020
- Testing
- Cholic Acids
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Biliary Atresia
Tolerability of Enteral NAC in Infants
Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation.
- Trial name
- NCT06260566
- Testing
- N-Acetylcysteine
- Volunteers
- 12 people
- Sponsor
- Sanjiv Harpavat
Biliary Atresia, Kasai
The Use of Near-Infrared Fluorescence Cholangiography With Indocyanine Green (ICG) in the Work Up of Neonatal Cholestasis
In infants that present with findings concerning for biliary atresia, along with other cholestatic work up which is standard, they will receive a one-time intravenous (IV) dose of Indocyanine Green (ICG).
- Conditions
- Biliary Atresia, Kasai, Cholestasis in Newborn, Cholestasis in Newborn Infant
- Trial name
- NCT07250854
- Testing
- Indocyanine Green
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Alagille Syndrome
Characterization of Pulmonary Artery Stenoses in Alagille Syndrome - a Medical Record Review
Patients who have Alagille Syndrome (AGS) also frequently have blockages (or "stenoses") of their pulmonary arteries. Little is known about the degree or variability of these stenoses, or the effect of this disease on the right…
- Trial name
- NCT01515631
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Stanford University
Cholestasis
Inter-regional Cohort of Neonatal and Infant Cholestasis in the Greater Southwest Region
The goal of the study is to characterize the epidemiologic data of the neonatal and infant cholestasis.
- Trial name
- CHOLESTASE (NCT02767648)
- Testing
- proteomic urine analysis
- Where
- 4 sites in France
- Volunteers
- 57 people
- Sponsor
- University Hospital, Toulouse
Biliary Atresia
Outcome of Kasai Portoenterostomy in Biliary Atresia in Upper Egypt
Kasai portoenterostomy is the key standard operation for biliary atresia. The aim of the study is to evaluate the short-term outcome of Kasai portoenterostomy for biliary atresia infants in Upper Egypt.
- Trial name
- NCT05925543
- Testing
- Kasai portoenterostomy operation.
- Where
- Egypt
- Volunteers
- 45 people
- Sponsor
- Aswan University Hospital
Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1
Baby Detect : Genomic Newborn Screening
Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions.
- Conditions
- Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1, Phosphoglucomutase 1 Deficiency, Maturity Onset Diabetes of the Young
- Trial name
- BabyDetect (NCT05687474)
- Where
- Belgium
- Volunteers
- 6,824 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Liege
Alagille Syndrome (ALGS), Progressive Familial Intrahepatic Cholestasis (PFIC)
A Database Study of Maralixibat (TAK-625) in Participants With Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC)
This study is a database study in Japan for maralixibat (TAK-625) used to treat participants with Alagille Syndrome (ALGS) and Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT07293897
- Testing
- Maralixibat
- Where
- Japan
- Volunteers
- 50 people
- Sponsor
- Takeda
Alagille Syndrome
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.
- Trial name
- ASSERT (NCT04674761)
- Testing
- Odevixibat
- Where
- 32 sites in United States, Belgium and 11 more
- Volunteers
- 52 people
- Sponsor
- Albireo
Cholestasis, Prematurity
Prevention of Parenteral Nutrition-Associated Cholestasis With Cyclic Parenteral Nutrition in Infants
Hypothesis to be Tested: Since the first description of intravenous alimentation over half a century ago, parenteral nutrition (PN) has become a common nutritional intervention for conditions characterized by inability to…
- Conditions
- Cholestasis, Prematurity, Gastroschisis, Intestinal Atresia
- Trial name
- NCT01062815
- Testing
- Parenteral Nutrition
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- University of Miami
Cholestasis
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates
The purpose of this study is to determine whether ursodiol is effective in the treatment of parenteral nutrition associated cholestasis in neonates.
- Trial name
- URSONEONAT (NCT00846963)
- Testing
- Ursodiol
- Where
- Canada
- Volunteers
- 26 people
- Sponsor
- Ibrahim Mohamed
Short Bowel Syndrome
Elemental Formula in Neonates Post Small Bowel Resection: Improved Weaning From Total Parenteral Nutrition?
In neonates with recent small bowel resection or congenital bowel anomalies (gastroschisis or omphalocele), does an elemental formula as compared to a partially hydrolyzed formula allowed the infant to wean off Total Parenteral…
- Trial name
- NCT01891279
- Testing
- elemental formula Elecare®, partially hydrolyzed formula
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- The University of Texas Health Science Center, Houston