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



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:1/28/2018
Start Date:March 29, 2017
End Date:June 18, 2019
Contact:Christos Papadelis, PhD
Email:Christos.Papadelis@childrens.harvard.edu
Phone:781-216-1128

Use our guide to learn which trials are right for you!

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 with
hypoxic ischemic injury) during oral sucking and feeding and correlate it with their
underlying neurological impairment for the early diagnosis of brain injury.

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 study includes three groups of infants: (i) group A consisting of preterm infants
(gestational age of <37 weeks), (ii) group B consisting of term infants admitted to the
Newborn Intensive Care Unit (NICU) at Boston Children's Hospital (BCH) for therapeutic
hypothermia who are at risk of developing hypoxic ischemic injury (HIE); have concerns for
neonatal stroke, and have seizures of unknown etiology and (iii) group C consisting of
healthy term infants in the community and term infants admitted to the NICU who had an
initial uncomplicated postnatal course that will serve as the control group. In group A,
infants will be further classified as not having a brain lesion in their anatomical MRI scan
(group A1) or having a brain lesion in their MRI (group A2).

This is a non-interventional study on infants at high-risk for neurological impairment. The
sucking data for groups A, B and C (if inpatient) will be gathered repeatedly over their stay
at BCH, and neuroimaging data will be collected prior to their discharge. For group C,
neuroimaging data will be gathered over the course of a single visit if recruited from the
community.

Inclusion Criteria:

- Preterm infants with GA<36 weeks

- Term infants with GA>36 weeks and evidence of HIE on their MRI

- Healthy term infants with GA=37-41 weeks, appropriate birth weight, 5 minute Apgar
score>8, and an uncomplicated postnatal course

Exclusion Criteria:

- major congenital anomalies

- maternal drug abuse

- craniofacial malformation

- short bowel syndrome

- metallic implants or pumps
We found this trial at
1
site
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 781-216-1128
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
?
mi
from
Boston, MA
Click here to add this to my saved trials