The overall purpose of this project is to to quantify the physiology of neonatal drug withdrawal and develop non-pharmacological techniques to help improve the therapeutic management of Neonatal Abstinence Syndrome (NAS).
Novel approaches to diagnosing and treating Neonatal Abstinence Syndrome (NAS) are needed for reducing prolonged pharmacological management, minimizing hospitalization and improving developmental outcomes in drug exposed newborns. This study seeks to examine the physiology and symptoms of drug withdrawal (e.g., irritability marked by movement activity; cardio-respiratory instabilities) in infants exposed to drugs in utero and test whether sensory stimuli (tactile, auditory) reduce dysregulated systems in the withdrawing infant. Candidates at-risk for NAS due to fetal drug exposure will be identified to investigators by the infant's primary medical caregiver. Investigators will use a modified-consecutive sampling technique, restricted by equipment and personnel availability, for enrolling infants. Participants will be studied throughout their hospitalization. Effects of stimulation will be examined at different stages of withdrawal. Efficacy of stimulation will be examined as a potential complementary treatment of NAS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available; designed by Wyss Institute, Harvard University, Cofab Design LLC) to provide gentle vibrations and sounds during mattress stimulations.
Absence of mattress Stochastic Vibratory Stimulation (SVS)
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Change in Infant Movement between Mattress ON and Mattress OFF (control)
Measure mean change in infant movement activity via limb sensors
Time frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Change in Infant Breathing between Mattress ON and Mattress OFF (control)
Measure mean change in infant respiratory rate via respiratory inductance plethysmography (RIP)
Time frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Change in Infant Heart Rate between Mattress ON and Mattress OFF(control)
Measure mean change in infant heart rate via Electrocardiography (ECG).
Time frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Change in Infant Temperature between Mattress ON and Mattress OFF (control)
Measure mean change in axillary temperature via temperature sensor.
Time frame: Single session throughout course of hospitalization. Each session may last up to 24 hours.
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