Clinical trials: Neonatal Hypoglycemia
Hyperinsulinism, Hypoglycemia Neonatal
Continuous Glucose Monitoring in Neonatal Hyperinsulinism
The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit.
- Trial name
- NCT06363929
- Testing
- Dexcom G6 continuous glucose monitor
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- MemorialCare Health System
Congenital Hyperinsulinism
GLP-1 Receptor Expression in CHI
The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients.
- Trial name
- GLP-1-CHI (NCT03768518)
- Testing
- 68Ga-exendin-4 PET/CT
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
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
Congenital Hyperinsulinism
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
- Trial name
- NCT04538989
- Testing
- RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2, RZ358 Sequential Group Cohort 3
- Where
- 17 sites in United States, Bulgaria and 9 more
- Volunteers
- 23 people
- Sponsor
- Rezolute
Neonatal Hypoglycemia
Continuous Glucose Monitoring in Infants
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.
- Trial name
- NCT04458649
- Testing
- Dexcom continuous glucose monitor
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Hyperglycemia, Hypoglycemia
Continous Glucose Monitoring in Neonates at Risk of Hypoglycaemia- a Feasibility Study
The study's main purpose is to test feasibility of Continous Glucose montoring in Neonates during the first 72 hrs.
- Conditions
- Hyperglycemia, Hypoglycemia, Hypoglycemia Neonatal
- Trial name
- CSBS I (NCT07375615)
- Testing
- Continous glucose monitor
- Where
- Norway
- Volunteers
- 25 people
- Sponsor
- Sykehuset Innlandet HF
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
Gestational Diabetes, Hypoglycemia, Neonatal
Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial
Pregnant women with gestational diabetes who are treated with insulin and their daily insulin dose is 30 IU or more will be randomized into two groups. Active treatment group will receive insulin-glucose-infusion during labour.
- Trial name
- NCT02590016
- Testing
- Insulin, Aspart
- Where
- Finland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Tampere University Hospital
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
Congenital Hyperinsulinism
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC).
- Trial name
- NCT04732416
- Testing
- HM15136
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 17 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Neonatal Hypoglycemia
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant
The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula.
- Trial name
- NCT04030312
- Testing
- Bottle Supplementation--Commercially-Sterilized Donor Human Milk, Bottle Supplementation--Standard Infant Formula
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Nebraska
Neonatal Hypoglycemia
Continuous Glucose Monitoring in At-Risk Newborns
Hypoglycemia (low blood glucose) is a very common problem in newborns, and has been associated with poor neurodevelopment, cognition, and school performance.
- Trial name
- NCT04386005
- Testing
- Continuous Glucose Monitoring Device
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Milton S. Hershey Medical Center
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, Neuroblastoma
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients with congenital hyperinsulinism 2. Pediatric patients with neuroblastoma 3.
- Conditions
- Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease
- Trial name
- NCT03042416
- Testing
- 18F-DOPA
- Where
- Canada
- Volunteers
- 400 people
- Sponsor
- University of Alberta
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
Hypoglycemia in Newborn Infants, Hyperglycemia
Hypoglycemic and Hyperglycemic Disorders
Definition of low birth weight: Low birth weight infants are those born weighing less than 2500 g. These are further subdivided into: Very Low Birth Weight : Birth weight <1,500 g Extremely Low Birth Weight : Birth weight <1,000…
- Trial name
- NCT03448965
- Testing
- random blood sugar
- Volunteers
- 100 people
- Sponsor
- Assiut University
Newborn, Full Term
Follow up Glucose Levels Among Infants of Diabetic Mothers
Infants to diabetic mothers (IDM) are at risk for developing hypoglycemia after birth. Glucose level follow ups are recommended to each IDM.
- Conditions
- Newborn, Full Term, Diabetic Mother
- Trial name
- NCT00337142
- Volunteers
- 250 people
- Sponsor
- Sheba Medical Center
Hypoglycaemia Neonatal
Prevention of Hypoglycaemia by Oral 40% Destrogel
Neonatal hypoglycemia understood as a reduction in plasma glucose can result in long-term neurological damage. Serious monitoring of neonatal blood glucose is indicated in patients at risk of hypoglycemia.
- Trial name
- NCT04185766
- Testing
- Administration of 40% glucose in gel (0.5 ml / Kg), Administration of 40% glucose in gel 1 ml / Kg)
- Where
- Italy
- Volunteers
- 172 people
- Sponsor
- Fondazione Poliambulanza Istituto Ospedaliero
Neonatal Hypoglycemia
The Feasibility of Cream for Treatment of Neonatal Hypoglycemia
Prolact CR (cream) is a fat supplement that is derived from pasteurized human donor milk. It has been utilized in babies who are born premature in the neonatal intensive care unit (NICU) setting to improve growth while avoiding…
- Trial name
- NCT07217483
- Testing
- Prolact CR for hypoglycemia
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Baylor Research Institute
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