Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

University of Massachusetts, Worcester

Status: Completed

Conditions: Neonatal Abstinence Syndrome

Treatments: Device: Stochastic Vibrotactile Stimulation (SVS); Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02768844

H00006578

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 46 patients

Sex: All

Ages: 1 day to 1 year old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

SVS vs Control

Experimental group

Description:

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.

Treatment:

Other: Control

Device: Stochastic Vibrotactile Stimulation (SVS)