Clinical trials: Neonatal Hypoglycemia
Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
Umbilical vein catheters (UVC) are commonly inserted in newborns especially neonates admitted to the Neonatal Intensive Care Unit (NICU).These catheters are used since 1959.
- Conditions
- Extreme Prematurity,Extremely Low Birthweight, Extremely Low Birth Weight, Very Low Birth Weight Infant, Neonatal Hypoglycemia
- Trial name
- NCT05022433
- Testing
- UVC insertion
- Where
- Singapore
- Volunteers
- 170 people
- Sponsor
- Singapore General Hospital
Congenital Hyperinsulinism
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
- Trial name
- NCT03777176
- Testing
- Dasiglucagon, Standard of Care
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 32 people
- Sponsor
- Zealand Pharma
Gestational Diabetes Mellitus in Pregnancy, Macrosomia, Fetal
Late Gestational Diabetes Mellitus Diagnosis in Obese Women
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…
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Macrosomia, Fetal, Dystocia, Shoulder, Neonatal Jaundice
- Trial name
- NCT05510518
- Testing
- oral glucose tolerance test (OGTT)
- Where
- Israel
- Volunteers
- 150 people
- Sponsor
- Western Galilee Hospital-Nahariya
Neonatal Hypoglycemia, Infant, Small for Gestational Age
Effect of Tahneek on Hypoglycemia in Newborn Infants
Tahneek is an Arabic word which means putting something sweet such as dates, in the infant's mouth after the birth. Neonatal hypoglycemia is common in the first few days after birth.
- Conditions
- Neonatal Hypoglycemia, Infant, Small for Gestational Age, Macrosomia, Fetal, Intrauterine Growth Restriction
- Trial name
- THIN (NCT03726697)
- Testing
- Tahneek
- Where
- Saudi Arabia
- Volunteers
- 324 people
- Sponsor
- King Abdullah International Medical Research Center
Glycogen Storage Disease Type I
Anaplerotic Therapy Using Triheptanoin for Patients With Glycogen Storage Disease Type I
This study will be an open-label, prospective, interventional feasibility pilot project to study the efficacy, safety, and tolerability of UX007 (triheptanoin) on reducing hypoglycemic events in patients with GSD I.
- Trial name
- NCT03665636
- Testing
- Triheptanoin
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Areeg El-Gharbawy
Hypoglycemia
Real-time Continuous Glucose Monitoring in Very Low Birth Weight Neonates
Hypoglycemia is frequent in very low birth weight (VLBW) neonates and compromises their neurological outcome. The aim of this study was to compare real-time continuous glucose monitoring system (RT-CGMS) to standard method by…
- Trial name
- NCT01942239
- Testing
- real time continuous glucose monitoring
- Where
- France
- Volunteers
- 48 people
- Sponsor
- University Hospital, Tours
Neonatal Hypoglycemia, Metabolic Complication
Pasteurised Donor Human Milk Supplementation for Term Babies
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in…
- Conditions
- Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay
- Trial name
- PRESENT (NCT06993103)
- Testing
- Standard care Cow's milk based formula, Dietary Supplement: PDHM Pasteurised Donor Human Milk
- Where
- 4 sites in Australia
- Volunteers
- 1,444 people
- Sponsor
- The University of Queensland
Congenital Hyperinsulinism
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to…
- Trial name
- NCT04172441
- Testing
- dasiglucagon
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Zealand Pharma
Obesity, Hypoglycemia Post Gastric Bypass Surgery
GLP1R-imaging in Post-RYGB Hypoglycemia
In order to evaluate the difference in beta cell mass in patients with and without hyperinsulinemic hypoglycemia after Roux en Y gastric bypass (RYGB) investigators aim to compare quantitative PET imaging of the pancreas between…
- Conditions
- Obesity, Hypoglycemia Post Gastric Bypass Surgery, Hyperinsulinemic Hypoglycemia
- Trial name
- NCT05597475
- Testing
- GLP-1R PET
- Where
- Netherlands
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Rijnstate Hospital
Glycogen Storage Disease Type III
Clinical Survey Study to Assess Physical Function and the Incidence of Hypoglycemia in Participants With Glycogen Storage Disease Type III
The primary objective of this study is to evaluate the incidence of hypoglycemia in adult and pediatric participants with glycogen storage disease type III (GSD III).
- Trial name
- NCT05196165
- Testing
- No Intervention
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 14 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Sterility, Placenta; Implantation
A Lifestyle Intervention to Improve in Vitro Fertilization Results
Embryo adhesion and placentation depend on tissue plasminogen activator (tPA)-mediated activation of brain-derived neurotrophic factor, vascular endothelial growth factor and other growth factors, formation of hemidesmosomes, and…
- Conditions
- Sterility, Placenta; Implantation, Risk Reduction Behavior, Lifestyle
- Trial name
- W+D (NCT02648555)
- Testing
- Daily walking, Dietary recommendations
- Where
- Brazil
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Hospital dos Servidores do Estado do Rio de Janeiro
Once a Preterm Developed Hypoglycemia, no More Blood Glucose Was Measured During the Study Period.
Dextrose Infusion by Burettes Versus Dextrose Boluses in Prevention of Neonatal Hypoglycemia
NULL HYPOTHESIS • There is no difference in the incidence of hypoglycemia among preterms receiving either two hourly 10% dextrose boluses or 10% dextrose infusion by burettes during the 72 hours of admission in Special Care Unit…
- Trial name
- NCT01688674
- Testing
- 10% dextrose
- Where
- Uganda
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Makerere University
Glycogen Storage Disease
Clinical Evaluation of a Non-Invasive Hypoglycemia Detector in a Glycogen Storage Disease Population
Glycogen storage disease (GSD) patients frequently experience periods of hypoglycemia, putting them at risk for several complications, such as hepatomegaly, adenomas, and cirrhosis.
- Trial name
- NCT02338817
- Testing
- Diabetes Sentry
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Florida
Infant Development, Hypoglycemia Neonatal
Continuous Glucose Monitoring and Cerebral Oxygenation in Preterm Infants
Neonatal hypoglicaemia is associated with impaired neurodevelopment outcomes in preterm infants. Thus, hypoglicemic events should be diagnosed and treated promptly.
- Conditions
- Infant Development, Hypoglycemia Neonatal, Neurodevelopmental Abnormality
- Trial name
- Glucolight (NCT04347590)
- Testing
- Unblinded - CGM (Medtronic Guardian), Blinded - CGM (Medtronic Guardian)
- Where
- Italy
- Volunteers
- 60 people
- Sponsor
- University Hospital Padova
Congenital Hyperinsulinism
Sandostatine® LP and Hyperinsulinism
To replace Sandostatine® in three daily subcutaneous injections by a single intramuscular injection of Sandostatine® LP per month in patients with a diffuse form of hyperinsulinism.
- Trial name
- NCT00987168
- Testing
- Sandostatine LP
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Congenital Disorders of Glycosylation
Clinical and Basic Investigations Into Known and Suspected Congenital Disorders of Glycosylation
Background: Proteins, fats, and other molecules are the body s building blocks. Many of these molecules must have sugars, or chains of sugars, attached to work properly.
- Trial name
- NCT02089789
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- National Human Genome Research Institute (NHGRI)
Insulinoma, Nesidioblastosis
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients.
- Trial name
- NCT02560376
- Testing
- 68Ga-NOTA-exendin-4
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Peking Union Medical College Hospital
Congenital Hyperinsulinism
RZ358 Treatment for Congenital Hyperinsulinism
The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to…
- Trial name
- sunRIZE (NCT06208215)
- Testing
- RZ358 (5-10 mg/kg) + SOC
- Where
- 18 sites in United States, Bulgaria and 11 more
- Volunteers
- 56 people
- Sponsor
- Rezolute
Neonatal Hypoglycemia
To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.
Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important.
- Trial name
- NCT02838875
- Testing
- Blood samples
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Tel-Aviv Sourasky Medical Center
Neonatal Hypoglycemia, Gestational Diabetes Mellitus (GDM)
COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus
The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.
- Trial name
- COMET-GDM (NCT07462793)
- Testing
- Dexcom ONE Continuous Glucose Monitoring System
- Where
- Poland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Institute of Mother and Child, Warsaw, Poland