Neonatal Abstinence SyndromeNCT02768844
Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
A study testing Stochastic Vibrotactile Stimulation (SVS) in people with Neonatal Abstinence Syndrome, run by University of Massachusetts, Worcester at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Stochastic Vibrotactile Stimulation (SVS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
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).
Read the detailed 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.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Stochastic Vibrotactile Stimulation (SVS), Control
- Keywords
- Stochastic Resonance, Fetus/Newborn Infant, Drug Withdrawal, Substance Abuse
- Medical subject headings
- Neonatal Abstinence Syndrome, Substance Withdrawal Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stochastic Vibrotactile Stimulation (SVS)Device
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.
ControlOther
Absence of mattress Stochastic Vibratory Stimulation (SVS)
| Study group | Role | What they receive |
|---|---|---|
| SVS vs Control | Experimental | 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. Receives: Device: Stochastic Vibrotactile Stimulation (SVS); Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Infant Movement between Mattress ON and Mattress OFF (control)
Measure mean change in infant movement activity via limb sensors
Measured: 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)
Measured: 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).
Measured: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Secondary outcomes (1)
Change in Infant Temperature between Mattress ON and Mattress OFF (control)
Measure mean change in axillary temperature via temperature sensor.
Measured: Single session throughout course of hospitalization. Each session may last up to 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startApr 2011
- Primary completion23 Jan 2014
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth B Salisbury, Ph.D., Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768844
- Sponsor's protocol ID
- H00006578
- Status last verified
- Dec 2020
- First submitted
- 2 May 2016
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bloch-Salisbury E, Rodriguez N, Bruch T, McKenna L, Goldschmidt L. Physiologic dysregulation in newborns with prenatal opioid exposure: Cardiac, respiratory and movement activity. Neurotoxicol Teratol. 2022 Jul-Aug;92:107105. doi: 10.1016/j.ntt.2022.107105. Epub 2022 May 27.
PubMed 35636580Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.
PubMed 33348423
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
- ClinicalTrials.gov ID
- NCT02768844
- Acronym / sponsor ID
- H00006578
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- Stochastic Resonance, Fetus/Newborn Infant, Drug Withdrawal, Substance Abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- 23 Jan 2014 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SVS vs Control | Experimental | Device: Stochastic Vibrotactile Stimulation (SVS), Other: ControlProspective, 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. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | SVS vs Control |
| ControlAbsence of mattress Stochastic Vibratory Stimulation (SVS) | Other | SVS vs Control |
Primary outcome
Change in Infant Movement between Mattress ON and Mattress OFF (control)
Time frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Measure mean change in infant movement activity via limb sensors
Change in Infant Breathing between Mattress ON and Mattress OFF (control)
Time frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Measure mean change in infant respiratory rate via respiratory inductance plethysmography (RIP)
Change in Infant Heart Rate between Mattress ON and Mattress OFF(control)
Time frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Measure mean change in infant heart rate via Electrocardiography (ECG).
1 secondary outcome
Change in Infant Temperature between Mattress ON and Mattress OFF (control)
Time frame: Single session throughout course of hospitalization. Each session may last up to 24 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Derived from this study: PubMed 35636580Bloch-Salisbury E, Rodriguez N, Bruch T, McKenna L, Goldschmidt L. Physiologic dysregulation in newborns with prenatal opioid exposure: Cardiac, respiratory and movement activity. Neurotoxicol Teratol. 2022 Jul-Aug;92:107105. doi: 10.1016/j.ntt.2022.107105. Epub 2022 May 27.
- Derived from this study: PubMed 33348423Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.
- Individual participant dataSharing planned: No
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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth B Salisbury, Ph.D. principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stochastic Vibrotactile Stimulation (SVS) in people with Neonatal Abstinence Syndrome, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Infant Movement between Mattress ON and Mattress OFF (control) (time frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02768844, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.