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

Terminated

• Conditions: Neonatal Abstinence Syndrome; Hypoxic-Ischemic Encephalopathy; Hypoglycemia
• Interventions: Device: nfant feeding solution

• Registration Number: NCT03246243
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2017-03-29
• Study First Submitted: 2017-06-21
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Status Verified: 2021-05
• Primary Completion: 2021-05-18
• Study Completion: 2021-05-18
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Term infants with HIE or at risk of brain injury	nfant feeding solution	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.
Preterm infants	nfant feeding solution	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.
Term infants healthy at birth	nfant feeding solution	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.

Primary Outcome Measures

Name	Time	Method
Difference in sucking activity of infants with brain injury	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.

Secondary Outcome Measures

Name	Time	Method
Sucking activity of infants and brain connectivity	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.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States