Clinical trials: Neonatal Hypoglycemia
Neonatal Hypoglycemia
Early Breast Feeding and Glucose Levels in High Risk Newborns
Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding.
- Trial name
- NCT00332449
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Congenital Hyperinsulinism, Hyperinsulinism
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug…
- Conditions
- Congenital Hyperinsulinism, Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy, CHI
- Trial name
- NCT00674440
- Testing
- F-DOPA, PET scan
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Children's Hospital of Philadelphia
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
Hypoglycemia, Neonatal Hypoglycemia
Effects of a Hypoglycemia Protocol With Glucose Gel on Neonatal Intensive Care Unit (NICU) Admission
Evaluate if the implementation of a hypoglycemia protocol with glucose gel has reduced the NICU admission rate of neonates with low-acuity neonatal hypoglycemia.
- Trial name
- NCT04085978
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Pediatrix
Prader Willi Syndrome, Hypoglycemia
Hypoglycemia in Prader-Willi Syndrome
This project will study whether infants with Prader-Willi Syndrome experience low blood sugars after short periods of fasting. This study will also evaluate metabolic markers in the blood to determine if infants with Prader-Willi…
- Trial name
- NCT01897363
- Testing
- Infants with Prader-Willi Syndrome
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Florida
Congenital Hyperinsulinism (CHI), Beckwith-Wiedemann Syndrome
18F-L-Fluoro-DOPA PET/CT Scan Localization of Focal Pancreatic Lesions in Subjects With Hyperinsulinemic Hypoglycemia
This purpose of this study is to determine the ability of an 18F-fluoro-L-dihydroxyphenylalanine (18F-DOPA) PET (Positron Emission Tomography) scan to detect a focal lesion of hyperinsulinism and determine the location in…
- Conditions
- Congenital Hyperinsulinism (CHI), Beckwith-Wiedemann Syndrome, Insulinoma
- Trial name
- NCT01916148
- Testing
- 18F-DOPA
- Where
- United States
- Sponsor
- Children's Hospital of Philadelphia
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
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
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
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
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
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, Neonatal Hyperglycaemia
Glucose Disturbances in Premature Infants and Quality of Life
The aim of this study is to investigate the correlation between preterm birth, glucose level in the first two hours of life and health related quality of life in the age of 8 months and 7 years
- Trial name
- NCT04770636
- Where
- Croatia
- Volunteers
- 150 people
- Sponsor
- Clinical Hospital Center Rijeka
Hyperinsulinemic Hypoglycemia, Persistent, Congenital Hyperinsulinism
Study of the Use of [18F]-DOPA in Hyperinsulinemic Hypoglycemia
The primary objective of this study is to evaluate the utility of [18F]-DOPA PET to provide improved presurgical planning and distinguish between focal and diffuse forms of HI.
- Conditions
- Hyperinsulinemic Hypoglycemia, Persistent, Congenital Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
- Trial name
- [18F]-DOPA (NCT02533219)
- Testing
- 18 F-DOPA
- Where
- United States
- Sponsor
- Baylor College of Medicine
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
Hypoglycaemia
Point of Care Ketone Measurement in the Newborn
Low blood sugar levels are common in babies after birth. This may be normal as babies can use other sources of energy. However if a baby does not produce these fuels the brain can be starved of energy and be damaged.
- Trial name
- POCKET (NCT02341313)
- Where
- United Kingdom
- Volunteers
- 50 people
- Sponsor
- Kathryn Beardsall
Hypoglycemia
Glucagon in the Treatment of Hypoglycemia in Newborn Infants of Diabetic Mothers
Thesis Infants of diabetic mothers are at high risk to develop hypoglycemia after birth. After birth, glucose and ketone bodies are the main substrates of brain energy.
- Trial name
- NCT00434772
- Testing
- glucagon
- Where
- Israel
- Sponsor
- Shaare Zedek Medical Center
Transient; Hypoglycemia, Neonatal, Preterm
Oral Glibenclamide in Preterm Infants With Hyperglycaemia (GALOP)
The purpose of this study is to confirm hypothesis that Glibenclamide can be administered orally and is an alternative to insulin therapy in treating transient hyperglycemia of premature newborns.
- Conditions
- Transient; Hypoglycemia, Neonatal, Preterm, Glibenclamide Adverse Reaction
- Trial name
- GALOP (NCT05687500)
- Testing
- Glibenclamide, Pharmacokinetics study, C-peptide proinsulin ratio
- Where
- France
- Volunteers
- 35 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Congenital Hyperinsulinism
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism.
- Trial name
- NCT00897676
- Testing
- Exendin-(9-39)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Diva De Leon
Premature Birth, Neonatal Hypoglycemia
Higher-Dose Dexamethasone Improves Breathing and Shortens NICU Stay in Preterm Babies
The goal of this observational study was to compare two doses of dexamethasone given to pregnant women at risk of preterm birth. Dexamethasone is a medicine used before birth to help a baby's lungs mature.
- Conditions
- Premature Birth, Neonatal Hypoglycemia, Maternal Infection During Pregnancy, Neurodevelopmental Disorder of Foetus
- Trial name
- NCT07765329
- Testing
- Dexamethasone 12 mg Every 12 Hours, Dexamethasone 6 mg Every 12 Hours
- Where
- Indonesia
- Volunteers
- 200 people
- Sponsor
- Stella Maris Women and Children Hospital