- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03246243
Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
Study Overview
Status
Intervention / Treatment
Detailed Description
This research will address the current lack of objective tools for the reliable assessment of oral sucking and feeding in clinical practice, and the insufficient evidence that relates early measures of abnormal sucking activity with the underlying neurological impairment.
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. We aim to study three groups of infants who are inpatients on the Neonatal Intensive Care Unit (NICU) at Boston Children's Hospital (BCH), the NICU or Newborn Nursery at Beth Israel Deaconess Medical Center (BIDMC), the Special Care Nursery (SCN) or Newborn Nursery at Winchester Hospital as follows: (i) group A consisting of preterm infants (gestational age of <37 weeks), (ii) group B consisting of term infants admitted to the NICU at BCH and BIDMC for therapeutic hypothermia who are at risk of developing hypoxic ischemic injury (HIE); admitted with concern for neonatal stroke; seizures of unknown etiology; and those admitted to the NICU, SCN or Newborn Nursery at BCH, BIDMC and Winchester Hospital at risk of abnormal neurodevelopment such as those with hypoglycemia or neonatal abstinence syndrome (NAS) and; (iii) group C consisting of healthy term infants admitted to the NICU, SCN or nursery who had an initial uncomplicated postnatal course that will serve as the control group. Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Boston Children's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Preterm infants
Group A will consist of preterm infants born < 37 weeks gestational age.
Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity.
Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly.
If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record.
Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.
|
The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity.
Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.
|
Term infants with HIE or at risk of brain injury
Group B will consist of term infants admitted to the NICU for therapeutic hypothermia who are at risk of HIE; admitted with concern for neonatal stroke; seizures of unknown etiology; and those admitted who are at risk of abnormal neurodevelopment such as those with hypoglycemia or NAS.
Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity.
Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly.
If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record.
Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.
|
The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity.
Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.
|
Term infants healthy at birth
Group C will consist of healthy term infants from the community and term infants admitted to who had an initial uncomplicated postnatal course that will serve as the control group.
Non-nutritive and nutritive sucking will be assessed using an FDA-approved device (Nfant Feeding Solution) to measure sucking activity.
Additionally, those infants who have MRI of the brain for any reason during the course of their hospital admission will also be included in the study and allocated to the appropriate group accordingly.
If a subject undergoes any clinically ordered EEG, EMG, MEG, and MRI throughout the duration of their study participation before the age of three then that data will be collected from their medical record.
Additionally, any neurodevelopmental testing data completed up to the age of three will be collected.
|
The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity.
Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in sucking activity of infants with brain injury
Time Frame: Approximately one year through study completion
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sucking activity of infants and brain connectivity
Time Frame: Approximately three years through study completion
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Cerebrovascular Disorders
- Central Nervous System Diseases
- Nervous System Diseases
- Substance-Related Disorders
- Wounds and Injuries
- Infant, Newborn, Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Signs and Symptoms, Respiratory
- Hypoxia
- Hypoxia, Brain
- Brain Ischemia
- Brain Injuries
- Hypoglycemia
- Brain Diseases
- Hypoxia-Ischemia, Brain
- Neonatal Abstinence Syndrome
Other Study ID Numbers
- IRB-P00023193
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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