Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

Conditions
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Neonatal Abstinence Syndrome

Intervention / Treatment
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* Device: Stochastic Vibrotactile Stimulation (SVS)
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible subjects are infants currently inpatient in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital and: Full-term infants (>37 wks gestational age) and late preterm infants (34-37 wks gestational age) Newborns at risk for NAS due to fetal-drug exposure At-risk infants will be infants who present with confirmed meconium and/or urine toxicology report (documented in medical chart review) for opioids (e.g., methadone, buprenorphine/subutex, oxycodone, heroin); may also have prenatal exposure to benzodiazepines, barbiturates, amphetamines, cannabinoids, alcohol, nicotine and/or caffeine. Exclusion Criteria: Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she: Born less than <34 weeks. Has a congenital abnormality Has a fetal anomaly Has hydrocephalus or intraventricular hemorrhage >grade 2 Has a seizure disorder not related to drug withdrawal Has a clinically significant shunt Requires mechanical respiratory support

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SVS vs Control<br>Prospective, within-subject design. Compare effects of mattress SVS (ON) and Control (SVS OFF) on physiology in opioid-exposed newborns. SVS is alternated in intervals between continuous stimulation (ON) and no stimulation (OFF/Control) throughout inter-feed intervals. The order of the ON-OFF cycles is randomized across subjects and counterbalanced between feeding periods within subjects. | Device: Stochastic Vibrotactile Stimulation (SVS)<br>* 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.<br>Other: Control<br>* Absence of mattress Stochastic Vibratory Stimulation (SVS)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Infant Movement between Mattress ON and Mattress OFF (control) | Measure mean change in infant movement activity via limb sensors | 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) | 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). | Single sessions throughout course of hospitalization. Each session may last up to 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Infant Temperature between Mattress ON and Mattress OFF (control) | Measure mean change in axillary temperature via temperature sensor. | Single session throughout course of hospitalization. Each session may last up to 24 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stochastic Resonance, Fetus/Newborn Infant, Drug Withdrawal, Substance Abuse