Clinical trials: Neonatal Cholestasis
Intrahepatic Cholestasis of Pregnancy
Predictors of Adverse Neonatal Outcomes in Intrahepatic Cholestasis of Pregnancy
Many studies have attempted to find the predictors of adverse neonatal outcome in women with Intrahepatic Cholestasis of Pregnancy(ICP).Serum total bile acid level exceeding 40 µmol/L has been associated with increased risk of…
- Trial name
- NCT04922580
- Where
- China
- Volunteers
- 700 people
- Sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Cholestasis in Newborn, Biliary Atresia
The Dirty Nappy Study
This observational study evaluates whether a machine-learning algorithm, a computer program that learns patterns from data, can accurately diagnose cholestasis in newborns.
- Conditions
- Cholestasis in Newborn, Biliary Atresia, Neonatal Cholestasis
- Trial name
- NCT07697872
- Where
- United Kingdom
- Volunteers
- 5,350 people, healthy volunteers welcome
- Sponsor
- Birmingham Women's and Children's NHS Foundation Trust
Necrotizing Enterocolitis, Digestive System Abnormalities
Brain Manganese Deposition in High Risk Neonates
Excessive exposure to manganese (Mn) results in Mn deposition in the brain causing adverse neurological effects. Sick infants requiring parenteral nutrition (PN) may be at increased risk of Mn neurotoxicity because neonatal PN…
- Conditions
- Necrotizing Enterocolitis, Digestive System Abnormalities, Cholestasis
- Trial name
- NCT00392977
- Testing
- remove Mn from PN if evidence of increased brain Mn on MRI
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Vanderbilt University
Cholestasis, Liver Diseases
Omegaven for Compassionate Use in the Treatment of Parenteral Nutrition-Associated Liver Disease
This is a compassionate use protocol of an investigational new drug (IND). The overall purpose of the treatment is to offer alternative treatment to children who developed parenteral nutrition-associated liver disease (PNALD) and…
- Trial name
- NCT03072667
- Testing
- Omegaven
- Where
- United States
- Sponsor
- Catherine Cibulskis, MD
Cholestasis
Sincalide (Cholecystokinin Octapeptide) Versus Placebo in Neonates at High Risk for Developing Parenteral Nutrition Associated Cholestasis
OBJECTIVES: I. Compare conjugated bilirubin levels and serum bile acid levels in severely premature newborns on long term parenteral nutrition and given either sincalide or placebo. II.
- Trial name
- NCT00004414
- Testing
- sincalide
- Where
- 6 sites in United States
- Volunteers
- 252 people
- Sponsor
- University of Michigan
Intrahepatic Cholestasis of Pregnancy
Different Effects of Delayed Clamping on Neonatal Bilirubin Levels Between Pregnant Women With Intrahepatic Cholestasis of Pregnancy and Normal Pregnant Women
Objective:The aim of this study was to investigate the relationship between delayed cord clamping and neonatal bilirubin levels in pregnant women with intrahepatic cholestasis of pregnancy.
- Trial name
- NCT05637151
- Testing
- clamp time of umbilical
- Where
- China
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Premature Birth
Total Parenteral Nutrition Associated Cholestasis (TPNAC) and Plasma Amino Acid Levels in Neonates
The purpose of this study is to analyze if the infants who received Primene solution, have lower serum levels of methionine and cysteine and higher serum levels of taurine, we also analyze if the infants who received Primene…
- Trial name
- TPNAC (NCT01062724)
- Testing
- Primene 10 % from Baxter
- Where
- Mexico
- Volunteers
- 94 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome
A Study to Evaluate the Safety and Tolerability of Maralixibat in Infant Participants With Cholestatic Liver Diseases Including Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome (ALGS).
This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in children <12 months of age with Alagille Syndrome [ALGS] or Progressive Familial Intrahepatic Cholestasis [PFIC].
- Conditions
- Progressive Familial Intrahepatic Cholestasis, Alagille Syndrome, Cholestatic Liver Disease
- Trial name
- RISE (NCT04729751)
- Testing
- Maralixibat
- Where
- 14 sites in United States, Belgium and 5 more
- Volunteers
- 27 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis in Newborn
Impact of Cyclic Prolonged Parenteral Nutrition in Neonates
The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN.
- Trial name
- NCT02692326
- Testing
- Cyclic parenteral nutrition
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Hospital General Universitario Gregorio Marañon
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
Parenteral Nutrition-Associated Liver Disease
Low Dose Parenteral Fat for Prevention of Parenteral Nutrition Associated Cholestasis in Preterm Neonates
The goal of the study is to determine if parenteral nutrition-associated cholestasis (PNAC) is related to the amount of parenteral (intravenous) fat administered to premature babies until full enteral nutrition is achieved.
- Trial name
- NCT01050660
- Testing
- Intravenous fat emulsion, Restriction of intravenous fat emulsion to 1 gm/kg/d
- Where
- United States
- Volunteers
- 136 people
- Sponsor
- Yale University
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Subjects With Alagille Syndrome (ALGS)
The purpose of this extension study is to determine the long-term safety and tolerability of an investigational treatment (LUM001 also known as Maralixibat) in children with ALGS who have completed participation in a core LUM001…
- Trial name
- IMAGINE (NCT02047318)
- Testing
- LUM001 (Maralixibat)
- Where
- 3 sites in United Kingdom
- Volunteers
- 19 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis, Congenital Heart Disease
Congenital Heart Diseases and Developmental Assessment in Cholestatic Infants Under Two Years
Congenital heart diseases (CHDs) are common in infants with cholestasis due to shared prenatal and metabolic factors. This study aims to determine the frequency and types of CHDs and to assess physical and mental development in…
- Trial name
- NCT07247604
- Volunteers
- 106 people
- Sponsor
- Assiut University
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
Alagille Syndrome
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
This is a multicentre, extension study of LUM001 in children diagnosed with Alagille Syndrome who have completed participation in a core LUM001 treatment protocol.
- Trial name
- IMAGINE-II (NCT02117713)
- Testing
- LUM001 (Maralixibat)
- Where
- 11 sites in United States, Canada
- Volunteers
- 34 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Cholestasis in Newborn
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late…
- Trial name
- NCT06366880
- Testing
- Parenteral nutrition cycling
- Where
- Mexico
- Volunteers
- 66 people
- Sponsor
- Hospital Pediátrico de Sinaloa
Alagille Syndrome
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and…
- Trial name
- IMAGO (NCT01903460)
- Testing
- LUM001
- Where
- 3 sites in United Kingdom
- Volunteers
- 20 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
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
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
The study is a randomized, double-blind, placebo-controlled study in children with Alagille Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on pruritus, serum bile acids, liver enzymes, and…
- Trial name
- ITCH (NCT02057692)
- Testing
- LUM001
- Where
- 13 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Liver Diseases, Alagille Syndrome
Longitudinal Study of Genetic Causes of Intrahepatic Cholestasis (LOGIC)
Cholestasis is a condition in which bile is not properly transported from the liver to the small intestine. Cholestasis can be caused by an array of childhood diseases, including the genetic diseases Alagille syndrome (ALGS)…
- Conditions
- Liver Diseases, Alagille Syndrome, Alpha 1-Antitrypsin Deficiency
- Trial name
- LOGIC (NCT00571272)
- Where
- 17 sites in United States, Canada
- Volunteers
- 1,675 people
- Sponsor
- Arbor Research Collaborative for Health