Hypoglycemia Clinical Trial
Official title:
Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
NCT number | NCT03246243 |
Other study ID # | IRB-P00023193 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | March 29, 2017 |
Est. completion date | May 18, 2021 |
Verified date | May 2021 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The main goal of this study is to quantitatively assess the sucking and feeding activity of infants at high risk of neurological impairment (preterm infants and term infants at risk of abnormal neurodevelopment) during oral sucking and feeding and correlate it with their underlying neurological impairment for the early diagnosis of brain injury.
Status | Terminated |
Enrollment | 16 |
Est. completion date | May 18, 2021 |
Est. primary completion date | May 18, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 6 Months |
Eligibility | Inclusion Criteria: - Preterm infants with GA<37 weeks - Term infants with GA>37 weeks and at risk of brain injury - Healthy term infants with GA= 37-41 weeks, appropriate birth weight, 5 minute Apgar score>7, and an initial uncomplicated postnatal course Exclusion Criteria: - major congenital anomalies - craniofacial malformation - short bowel syndrome |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Beth Israel Deaconess Medical Center, Winchester Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in sucking activity of infants with brain injury | Primary outcome will be an assessment of the sucking activity of infants with brain injury and infants without brain injury, using an FDA-approved device for sucking assessment. | Approximately one year through study completion | |
Secondary | Sucking activity of infants and brain connectivity | The functional and structural connectivity of the brain areas involved in sucking and feeding in infants with brain injury will be assessed reviewing the results of clinically ordered neuroimaging and neurodevelopmental tests. | Approximately three years through study completion |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03482154 -
Malglycemia in the Pediatric Hematopoietic Stem Cell Transplant Population
|
||
Completed |
NCT03667053 -
Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children
|
Phase 3 | |
Active, not recruiting |
NCT03422471 -
Hypoglycemia and Autonomic Nervous System Function- B2
|
N/A | |
Recruiting |
NCT05379686 -
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
|
N/A | |
Completed |
NCT05597605 -
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
|
N/A | |
Not yet recruiting |
NCT05990933 -
Role of Adrenaline in in the Inflammatory Response in Diabetes
|
N/A | |
Withdrawn |
NCT03736083 -
Introducing CGM at Type 1 Diabetes Diagnosis
|
N/A | |
Not yet recruiting |
NCT02909881 -
Dose Response Oxidation of a Sweet-corn Derived Sugar (PhytoSpherix) During Exercise in Endurance Trained Athletes
|
N/A | |
Completed |
NCT02966275 -
Post Bariatric Closed Loop Glucagon Trial
|
N/A | |
Withdrawn |
NCT02518022 -
How to be Safe With Alcoholic Drinks in Diabetes
|
N/A | |
Completed |
NCT02213003 -
Allogeneic Islet Cells Transplanted Onto the Omentum
|
Phase 1/Phase 2 | |
Completed |
NCT01147276 -
Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes
|
Phase 4 | |
Completed |
NCT01176656 -
Hypoglycemia: Physician and Patient Perspectives
|
N/A | |
Completed |
NCT00998374 -
Comparison Between Pyloric Preserving and Non-Pyloric Preserving Bariatric Surgery With Glucose Challenge
|
N/A | |
Terminated |
NCT01225159 -
Tight Glycaemic Control During Cardiac Surgery
|
N/A | |
Completed |
NCT00373854 -
Study of How Low Blood Sugar Affects the Way Blood Vessels Work
|
N/A | |
Completed |
NCT00285233 -
Delayed Mycophenolate Mofetil in Single-Donor Islet Allotransplantation in Type 1 Diabetes
|
Phase 1/Phase 2 | |
Recruiting |
NCT05916131 -
Pilot Feasibility Study for HypoPals, a Mobile Health Program for Improving Hypoglycemia Management.
|
N/A | |
Terminated |
NCT04026750 -
Insulin Tolerance Test Study in Patients With Type 1 Diabetes
|
Phase 1 | |
Completed |
NCT05133765 -
The SMART B Exercise Study :''The SMART Study''
|
N/A |