Clinical trials: Neonatal Hypoglycemia, active
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, 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
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
Congenital Hyperinsulinism, Neuroblastoma
18F-DOPA II - PET Imaging Optimization
A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism. 2.
- Conditions
- Congenital Hyperinsulinism, Neuroblastoma, Parkinson Disease, Lewy Body Disease
- Trial name
- NCT04706910
- Testing
- 18F-DOPA, Furosemide Injection
- Where
- Canada
- Volunteers
- 800 people
- Sponsor
- University of Alberta
Congenital Hyperinsulinism (CHI)
Umbilical Cord Glucose
Congenital hyperinsulinism (HI) causes persistent neonatal hypoglycemia that, if untreated, can lead to neurodevelopmental impairments (NDI) such as cognitive delays, cerebral palsy, epilepsy, and blindness.
- Trial name
- Save The Brain (NCT07795047)
- Testing
- For the screening, the interventions will be glucose measurements (and possibly G-BOBH), while follow-up assessments will include Bayley testing, EEG, and MRI.
- Volunteers
- 50 people
- Sponsor
- Odense University Hospital
Neonatal Hypoglycemia, Gestational Diabetes
Accuracy of Interstitial Continuous Glucose Sensors in Neonates
Low blood sugar in newborns is common and if prolonged or untreated may place them at increased risk for later learning and behavior challenges.
- Conditions
- Neonatal Hypoglycemia, Gestational Diabetes, Maternal Obesity Complicating Pregnancy, Small-for-gestational Age
- Trial name
- NCT07133906
- Testing
- Continuous glucose monitoring, Cerebral near-infrared spectroscopy
- Volunteers
- 114 people, healthy volunteers welcome
- Sponsor
- Women and Infants Hospital of Rhode Island
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)
Long QT Syndrome, Hypoglycemia
Frequency of Hypoglycemia in Children With Beta-blocker Treated Long QT-syndrome
The goal of this observational study is to investigate the frequency and characteristics of hypoglycemic episodes in children with long QT syndrome (LQTS) and beta-blocker treatment, specifically those receiving propranolol…
- Trial name
- LQThypo (NCT07233421)
- Testing
- Continuous Glucose Monitoring
- Where
- Finland
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Helsinki University Central Hospital
Preterm Birth, Hyperglycemia
Blood Glucose in Pregnant Non-diabetic Women During Treatment With Betamethasone for Fetal Lung Maturation
In case of threatening preterm birth, it is standard to recommend treatment with betamethasone to accelerate fetal lung maturation.
- Conditions
- Preterm Birth, Hyperglycemia, Neonatal Hypoglycemia, Threatened Preterm Labor
- Trial name
- NCT06794307
- Where
- Denmark
- Volunteers
- 25 people
- Sponsor
- University of Aarhus
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
Hypoxic Ischemic Encephalopathy of Newborn, Hyperglycemia
Continuous Glucose Monitoring in HIE
The aim of the study is to examine whether the use of continuous glucose monitoring (CGM) to guide the clinical management of glycaemic control will result into an increased time in the target glucose concentration.
- Conditions
- Hypoxic Ischemic Encephalopathy of Newborn, Hyperglycemia, Hypoglycemia
- Trial name
- NCT06563687
- Testing
- Dexcom ONE+
- Where
- 3 sites in Italy
- Volunteers
- 70 people
- Sponsor
- University of Campania Luigi Vanvitelli
Congenital Portosystemic Shunt, CPSS (Congenital Portosystemic Shunt)
International Registry of Congenital Portosystemic Shunt (IRCPSS)
Congenital Portosystemic Shunt (CPSS) is a rare condition important by the multiplicity and severity of associated complications.
- Trial name
- IRCPSS (NCT06041906)
- Testing
- Shunt Closure
- Where
- 26 sites in United States, Australia and 14 more
- Volunteers
- 500 people
- Sponsor
- Prof. Valérie Mc Lin
Spinal Muscular Atrophy, Fragile X Syndrome
Early Check: Expanded Screening in Newborns
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and…
- Conditions
- Spinal Muscular Atrophy, Fragile X Syndrome, Fragile X - Premutation, Duchenne Muscular Dystrophy
- Trial name
- NCT03655223
- Testing
- Confirmatory Testing
- Where
- United States
- Volunteers
- 30,000 people, healthy volunteers welcome
- Sponsor
- RTI International
Congenital Hyperinsulinism, Insulinoma
Fluorodopa F 18 in Congenital Hyperinsulinism and Insulinoma
Low blood sugars are known to cause brain damage in newborn babies. One of the most common causes of low blood sugars persisting beyond the new born period is a condition called congenital hyperinsulinism (HI).
- Trial name
- NCT02021604
- Testing
- Fluorodopa F 18
- Where
- United States
- Volunteers
- 250 people
- Sponsor
- Cook Children's Health Care System
Oesophageal Atresia, Dumping Syndrome
Dumping Syndrome and Esophageal Atresia
Dumping syndrome (DS) is frequent in oesophageal atresia (29%). In causing hypoglycaemia, it can be dangerous for neonates. Mechanisms of DS are actually partialy understood.
- Trial name
- DUMTORING (NCT04522193)
- Testing
- Glycemic Holter, gastric emptying scintigraphy, Holter ECG
- Where
- 2 sites in France
- Volunteers
- 15 people
- Sponsor
- University Hospital, Lille
Hyperinsulinism
Utility of 18FDOPA PET/MRI for Focal Hyperinsulinism
The purpose of the study is to provide access to 18F-DOPA PET to patients at Washington University and assess the utility of 18F-DOPA PET/MRI as a preoperative tool to detect and localize focal lesions in the pancreas that are…
- Trial name
- 18FDOPA HI (NCT05088798)
- Testing
- 18F-Fluoro Dopa PET/MRI Imaging
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Washington University School of Medicine
Congenital Hyperinsulinism
18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism
The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas…
- Trial name
- DOPA PET (NCT04205604)
- Testing
- 18F-Fluoro Dopa Imaging
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Miguel Pampaloni
Infant, Newborn
Effect of Paternal Touch on Sucking Performance, Comfort, and Glucose Levels in Newborns at Risk for Hypoglycemia
This randomized controlled trial aims to examine the effects of Gentle Human Touch applied by fathers during the first hours of life on sucking performance, comfort level, and blood glucose values in newborns at risk for…
- Trial name
- NCT07302412
- Testing
- Gentle Human Touch, Standard Care Group
- Where
- Turkey (Türkiye)
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Acibadem University
Type 1 Diabetes (T1D), Pregnancy
Automated Insulin for Management of Intrapartum Glycemia
The goal of this clinical trial is learn if automated insulin delivery (AID) systems can be used for glucose management during labor/delivery for pregnant people with type 1 diabetes (T1D).
- Conditions
- Type 1 Diabetes (T1D), Pregnancy, Pre-Gestational Diabetes
- Trial name
- AIMING (NCT06883344)
- Testing
- Automated insulin delivery (AID) system, Intravenous (IV) insulin
- Where
- 3 sites in United States
- Volunteers
- 150 people
- Sponsor
- University of California, San Francisco