Clinical trials: Neonatal Hypoglycemia
Neonatal Hypoglycemia, Metabolic Disease
Pattern of Metabolic Causes of Neonatal Hypoglycemia
Inborn errors of metabolism (IEM) are disorders in which there is a block at some point in the normal metabolic pathway caused by a genetic defect of a specific enzyme.
- Trial name
- NCT05977972
- Volunteers
- 100 people
- Sponsor
- Assiut University
Hypoglycemia, Infant, Small for Gestational Age
Dextrose Gel Does Not Prevent Neonatal Hypoglycemia
This was a quasi-experimental pilot study comparing blood glucose values 30 minutes after feeding alone or feeding + dextrose gel in newborns at risk for transient neonatal hypoglycemia.
- Conditions
- Hypoglycemia, Infant, Small for Gestational Age, Premature Birth of Newborn, Fetal Macrosomia
- Trial name
- NCT02523222
- Testing
- 40% Dextrose gel
- Where
- United States
- Volunteers
- 236 people
- Sponsor
- Baylor College of Medicine
Infants of Diabetic Mothers, Placenta
Placental Weight in Infants of Gestational Diabetic Mothers
This prospective cross-sectional study examined the relationship between placental weight and early neonatal outcomes, such as blood glucose levels within the first 24 hours and early neonatal morbidities in infants born to…
- Conditions
- Infants of Diabetic Mothers, Placenta, Hypoglycaemia
- Trial name
- NCT07765784
- Testing
- Blood Glucose Level
- Where
- Turkey (Türkiye)
- Volunteers
- 98 people
- Sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
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
Congenital Hyperinsulinism, Insulinoma
Pasireotide in Hyperinsulinemic Hypoglycemia
This is a small controlled pilot study to assess the effect of subcutaneous pasireotide on preventing hypoglycemia due to hyperinsulinism, including congenital hyperinsulinism and insulinoma.
- Conditions
- Congenital Hyperinsulinism, Insulinoma, Hyperinsulinism
- Trial name
- NCT03053284
- Testing
- Pasireotide 0.6Mg Solution for Injection, Saline Solution
- Sponsor
- Montefiore Medical Center
Hyperinsulinemic Hypoglycemia
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial…
- Trial name
- NCT03770637
- Testing
- Glucagon RTU
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Xeris Pharmaceuticals
Glycogen Storage Disease, Congenital Hyperinsulinism (CHI)
Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders
The goal of this clinical trial is to learn if a continuous glucose monitor (CGM) with predictive alerts works better than a CGM with standard alerts to prevent low blood sugar (hypoglycemia) in adults with inherited metabolic…
- Conditions
- Glycogen Storage Disease, Congenital Hyperinsulinism (CHI), Hypoglycemia
- Trial name
- NCT07614139
- Testing
- Continuous glucose monitor with threshold and predictive alerts (Dexcom G7), Continuous glucose monitor with threshold-only alerts (Dexcom ONE+)
- Where
- Italy
- Volunteers
- 11 people
- Sponsor
- University Hospital Padova
Congenital Hyperinsulinism
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with…
- Trial name
- NCT00571324
- Testing
- Exendin-(9-39), Vehicle
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Diva De Leon
Congenital Hyperinsulinism
A Single-Dose Open-Label Study of XOMA 358 in Subjects With Congenital Hyperinsulinism
The purpose of this study is to evaluate the safety and clinical pharmacology of a single dose pharmacokinetics and pharmacodynamics of XOMA 358 in subjects with hypoglycemia associated with congenital hyperinsulinism.
- Trial name
- NCT02604485
- Testing
- Cohort 1, Cohort 2, Cohort 3
- Where
- 2 sites in United States, United Kingdom
- Volunteers
- 10 people
- Sponsor
- XOMA (US) LLC
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
Neonatal Death, Preterm Birth
SURVIVAL PLUSS: Increasing Capacity for Mama-baby Survival in Post-conflict Uganda and South Sudan
Universal coverage of good quality facility based care globally could prevent nearly 113,000 maternal deaths, 531,000 stillbirths and 1.3 million neonatal deaths annually by 2020.
- Conditions
- Neonatal Death, Preterm Birth, Low Birthweight, Neonatal Hypoglycemia
- Trial name
- NCT02605369
- Testing
- Intervention arm: An integrated package
- Where
- Uganda
- Volunteers
- 1,877 people, healthy volunteers welcome
- Sponsor
- Makerere University
Gestational Diabetes Mellitus in Pregnancy, Pregestational Diabetes Mellitus
Intrapartum Glucose Control and Risk of Neonatal Hypoglycemia
The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in…
- Conditions
- Gestational Diabetes Mellitus in Pregnancy, Pregestational Diabetes Mellitus, Neonatal Hypoglycemia
- Trial name
- NCT06643351
- Testing
- Standard Intrapartum Glucose Target Range, Liberalized Intrapartum Glucose Target Range
- Where
- United States
- Volunteers
- 169 people
- Sponsor
- University of Pittsburgh
Hyperinsulinemic Hypoglycemia, Insulinoma
Application of Raw Corn Starch on Patients With Insulinoma
This will be a prospective single-arm before-and-after clinical trial in which raw corn starch (RCS) will be first applied on patients with unoperated insulinoma.
- Conditions
- Hyperinsulinemic Hypoglycemia, Insulinoma, Raw Corn Starch
- Trial name
- NCT03930368
- Testing
- low GI diet with regular supplementation of raw corn starch
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Peking Union Medical College Hospital
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
Hyperinsulinemic Hypoglycemia
Post-Gastric Bypass Hypoglycemia
Post-gastric bypass hyperinsulinemic hypoglycemia is a recently described disorder occurring in some patients after gastric bypass surgery for obesity.
- Trial name
- NCT01933490
- Testing
- high carbohydrate test meal, high carbohydrate test meal after pre-treatment with rapid acting aspart insulin, high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of Minnesota
Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia
Treatment of Post-bariatric Hypoglycaemia
This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg…
- Trial name
- SHERRY (NCT04836273)
- Testing
- Dasiglucagon, HyoPen
- Where
- Denmark
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Filip Krag Knop
Congenital Hyperinsulinism
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent…
- Trial name
- NCT02937558
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Xeris Pharmaceuticals
Neonatal Hypoglycemia
Comparing Heel Stick Glucoses in Neonates
Newborn babies can develop low blood sugar (glucose) which can lead to brain injury and poor developmental outcomes. Therefore, it is important to accurately measure the blood glucose in babies.
- Trial name
- CHECK IN (NCT04811612)
- Testing
- Warmed heel stick
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Arizona
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
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