Clinical trials: Neonatal Hypoglycemia
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
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
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
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
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
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
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
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
Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism
This is an open-label, multinational, multicenter, long-term safety and efficacy extension trial in patients with Congenital Hyperinsulinism (CHI) who completed either ZP4207-17103 (NCT04172441) or ZP4207-17109 (NCT03777176)…
- Trial name
- NCT03941236
- Testing
- dasiglucagon
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 42 people
- Sponsor
- Zealand Pharma
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
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
Cholestasis in Newborn
Parenteral Nutrition Cycling for Prevention of Cholestatic Syndrome in Newborn
Background: Despite the use of parenteral nutrition cycling (PNC) in neonatal intensive care units (NICU), there is limited evidence regarding the benefits in relation to the nutrición parenteral total (NPT) in term and late…
- Trial name
- NCT06366880
- Testing
- Parenteral nutrition cycling
- Where
- Mexico
- Volunteers
- 66 people
- Sponsor
- Hospital Pediátrico de Sinaloa
Hypoglycemia in Newborn Infants
Gel for Early Hypoglycaemia Prevention in Preterm Infants
The GEHPPI study is a multicentre placebo controlled randomized controlled trial that aims to prevent early hypoglycaemia in preterm newborns born at ≤32 week's gestation.
- Trial name
- GEHPPI (NCT04353713)
- Testing
- 40% Dextrose Gel, 2% carboxymethylcellulose gel
- Where
- 5 sites in Czechia, Ireland
- Volunteers
- 534 people, healthy volunteers welcome
- Sponsor
- University College Dublin
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
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
Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1
Baby Detect : Genomic Newborn Screening
Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions.
- Conditions
- Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1, Phosphoglucomutase 1 Deficiency, Maturity Onset Diabetes of the Young
- Trial name
- BabyDetect (NCT05687474)
- Where
- Belgium
- Volunteers
- 6,824 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Liege
Infant, Newborn, Diseases, Pregnancy in Diabetics
Diazoxide In the Management Of Hypoglycemic Neonates
Diazoxide is an oral hyperglycemic medication. Diazoxide has been proven effective for treating hypoglycemia in infants and children with some types of persistent hyperinsulinemic hypoglycemia.
- Conditions
- Infant, Newborn, Diseases, Pregnancy in Diabetics, Infant, Diabetic Mother, Hypoglycemia
- Trial name
- DIMOHN (NCT00994149)
- Testing
- Diazoxide, Ora-plus
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- University of Saskatchewan
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
Infant, Very Low Birth Weight, Neonatal Hypoglycemia
Continuous Glucose Monitoring and Preterm Infants
Neonatal hypoglycemia is associated with brain injury and impaired neurodevelopment outcomes in very low birth weight infants (VLBWI).
- Trial name
- CGM&VLBWI (NCT02583776)
- Testing
- Unblinded - CGM, Blinded - CGM
- Where
- 3 sites in United States, Italy
- Volunteers
- 50 people
- Sponsor
- University Hospital Padova
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