Clinical trial NCT03246243: Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
Official title: Quantitative Assessment of Sucking for Early Diagnosis of Brain Injury in Infants at High Risk
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypoxic-Ischemic Encephalopathy
Hypoglycemia
Neonatal Abstinence Syndrome
Keywords: Hypoxic Ischemic Encephalopathy
Bottle Feeding
Hypoglycemia
Neonatal Abstinence Syndrome
Abnormal Neurodevelopment
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
name: Winchester Hospital
First posted: 2017-08-11
Enrollment: 16
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants at risk of brain injury; Term infants at risk of brain injury; and Healthy term infants.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in sucking activity of infants with brain injury
timeFrame: Approximately one year through study completion
Secondary outcomes:
measure: Sucking activity of infants and brain connectivity
timeFrame: Approximately three years through study completion
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Christos Papadelis, PhD
role: PRINCIPAL_INVESTIGATOR
References: