Clinical trials: Hypoglycemia in Newborn Infants
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
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
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
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
Hypoglycemia, Newborn Morbidity
Efficacy of Continuous Glucose Monitoring in Neonates With Hypoglycemia
Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in infants with low blood glucose to improve how we care for these infants.
- Trial name
- NCT02300285
- Testing
- Continuous Glucose Monitoring
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Boston Children's Hospital
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
Congenital Hyperinsulinism
Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy
The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in children with congenital hyperinsulinism already treated with Octreotide by pump.
- Trial name
- NCT01070758
- Testing
- Lanreotide autogel
- Where
- Israel
- Volunteers
- 3 people
- Sponsor
- Sheba Medical Center
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
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
Hyperinsulinemia Hypoglycemia
Evaluation of Single Ascending Doses of Subcutaneous Exendin 9-39 in Patients With Post-Bariatric Hypoglycemia
This study is designed to evaluate the safety, efficacy, and pharmacokinetic profile of single ascending doses of exendin 9-39 administered by subcutaneous route in subjects with post-bariatric hypoglycemia.
- Trial name
- NCT02996812
- Testing
- Exendin (9-39)
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Tracey McLaughlin
Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia
Dasiglucagon in the Treatment of Postprandial Hypoglycaemia After Roux-en-Y Gastric Bypass
The aim of this study is investigating the effect of a novel glucagon analogue administration in gastric bypass operated individuals, who are reactive hypoglycemic.
- Trial name
- NCT03984370
- Testing
- ZP4207
- Where
- Denmark
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University Hospital, Gentofte, Copenhagen
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
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
Very Low Birth Weight Infant, Very Preterm Maturity of Infant
CGM Use in Preterm Infants
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and…
- Conditions
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Hyperglycemia
- Trial name
- NCT05436925
- Testing
- Dexcom G6 sensor Continuous Glucose Monitor (CGM)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of Minnesota
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
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
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
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
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
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