Clinical trials: Neonatal Diabetes
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
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
Diastolic Dysfunction, Neonatal Encephalopathy
Assessment of Diastolic Function During the Transitional Period and Infancy Using Serial Echocardiography
The goal of this single-centre longitudinal observational study is to create reference values for diastolic function parameters in neonates born at 35 weeks' gestation or above, and to assess the influence of pre-defined…
- Conditions
- Diastolic Dysfunction, Neonatal Encephalopathy, Small for Gestational Age at Delivery, Transient Tachypnea of the Newborn
- Trial name
- DiFuSE (NCT06200519)
- Where
- Ireland
- Volunteers
- 216 people, healthy volunteers welcome
- Sponsor
- University College Cork
Postpartum Urinary Incontinence, Postpartum Depression (PPD)
Prenatal Exercise Including Perineal Massage and Maternal-Neonatal Outcomes
The study is divided into three phases: Phase 1: Baseline survey to obtain an overall understanding of the current situation of voluntary participation in prenatal perineal massage.
- Conditions
- Postpartum Urinary Incontinence, Postpartum Depression (PPD), Neonatal Complications, Gestational Diabetes
- Trial name
- PEPM-RCT (NCT07314502)
- Testing
- Supervised prenatal exercise including antenatal perineal massage
- Where
- China
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- South China Normal University
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
Pregnancy, Neonatal Mortality
Scalable Public Health Empowerment, Research, and Education Sites (SPHERES)
SPHERES is a health service research trial in the Indonesian primary care system designed to improve health system performance using a structured data-driven action model.
- Conditions
- Pregnancy, Neonatal Mortality, Tuberculosis, Hepatitis B
- Trial name
- SPHERES (NCT07126041)
- Testing
- Prescription for Action (SPHERES Model)
- Where
- 2 sites in Indonesia
- Volunteers
- 1,750,000 people, healthy volunteers welcome
- Sponsor
- Oxford University Clinical Research Unit Indonesia
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
Diabetes Mellitus, Type 1, Monogenic Diabetes
Monogenic Diabetes Misdiagnosed as Type 1
The study has two aims: 1. To (1a) determine the frequency of monogenic diabetes misdiagnosed as type 1 diabetes (T1D) and (2) to define an algorithm for case selection. 2.
- Conditions
- Diabetes Mellitus, Type 1, Monogenic Diabetes, Neonatal Diabetes, Maturity-onset Diabetes in the Young (MODY)
- Trial name
- ADDAM (NCT03988764)
- Testing
- None AHT
- Where
- Canada
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Pregnancy, Gestational Diabetes Mellitus, Class A2
Intrapartum Glycemic Control in GDMA2
This is a randomized, parallel, controlled, non-inferiority trial to assess the impact of a tight versus a more liberalized intrapartum glycemic control in gestational diabetic mothers on neonatal glycemia.
- Conditions
- Pregnancy, Gestational Diabetes Mellitus, Class A2, Neonatal Hypoglycemia
- Trial name
- NCT05647798
- Testing
- Blood sugar check every 2 hours, Blood sugar check every 4 hours
- Where
- 2 sites in United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Inova Health Care Services
Neonatal Diabetes
NEWBIE Validate: Feasibility of a New Test to Measure Glucose in Newborn Blood Spots (NBS)
The aim of this feasibility laboratory study is to evaluate whether the laboratory testing pathway for glucose screening in newborn blood spots (NBS) can be done at scale, and that the glucose test has a carefully established…
- Trial name
- NCT04831723
- Where
- 4 sites in United Kingdom
- Volunteers
- 10,784 people, healthy volunteers welcome
- Sponsor
- Royal Devon and Exeter NHS Foundation Trust
Neonatal Diabetes
Effect of Food Composition on Postprandial Insulin Secretion in Neonatal Diabetes
Neonatal diabetes is diagnosed before 6 months of age and causes high blood glucose levels due to the pancreas not secreting insulin. Neonatal diabetes can be caused by a change in a DNA region called the KCNJ11 gene.
- Trial name
- FoND (NCT02921906)
- Testing
- High protein meal, High carbohydrate meal, Paracetamol
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Royal Devon and Exeter NHS Foundation Trust
Gestational Diabetes, Hypoglycemia, Neonatal
Glucose Control During Labour in Gestational Diabetes Mellitus With Insulin Treatment: A Randomized Controlled Trial
Pregnant women with gestational diabetes who are treated with insulin and their daily insulin dose is 30 IU or more will be randomized into two groups. Active treatment group will receive insulin-glucose-infusion during labour.
- Trial name
- NCT02590016
- Testing
- Insulin, Aspart
- Where
- Finland
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Tampere University Hospital