Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

Neonatal Abstinence Syndrome Clinical Trial

Official title:

Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768844
• Other study ID #: H00006578
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: December 15, 2019

Study information

• Verified date: December 2020
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 15, 2019
• Est. primary completion date: January 23, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Abstinence Syndrome
• Syndrome

Intervention

Device:
• Stochastic Vibrotactile Stimulation (SVS)
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.

Other:
• Control
Absence of mattress Stochastic Vibratory Stimulation (SVS)

Locations

Country	Name	City	State
United States	University of Massachusetts Medical School	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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.