Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk

Boston Children's Hospital

Status: Terminated

Conditions: Hypoglycemia; Neonatal Abstinence Syndrome; Hypoxic-Ischemic Encephalopathy

Treatments: Device: nfant feeding solution

Study type: Observational

Funder types: Other

Identifiers

NCT03246243

IRB-P00023193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: Under 6 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

16 participants in 3 patient groups

Preterm infants

Description:

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.

Treatment:

Device: nfant feeding solution

Term infants with HIE or at risk of brain injury

Description:

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.

Treatment:

Device: nfant feeding solution

Term infants healthy at birth

Description:

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.

Treatment:

Device: nfant feeding solution