Neonatal Abstinence SyndromeNCT02801331

Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome

A study testing Stochastic Vibrotactile Stimulation (SVS) in people with Neonatal Abstinence Syndrome, run by Elisabeth B Salisbury at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to examine the efficacy of a specially-constructed crib mattress that delivers gentle vibrations (stochastic vibrotactile stimulation) as a complementary, non-pharmacological intervention for treating drug withdrawal in newborns exposed to opioids in utero. Read more about this study

Who is it for?: Ages 1 hour to 18 months
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: 208 participants
Where: 1 siteUnited States
Study dates: 9 Mar 2017to 6 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 hour to 18 months
All sexes
No healthy volunteers
Child

Inclusion Criteria: Eligible subjects are infants currently in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital or at Magee Women's Hospital of UPMC and:

Full-term infants (≥37 wks gestational age)
Newborns at risk for NAS due to opioid-exposure in utero
At-risk infants will be infants who present with confirmed meconium and/or urine toxicology report and/or documented medical record 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 <37weeks.
Has a clinically significant congenital abnormality
Has a clinically significant fetal anomaly
Has hydrocephalus or intraventricular hemorrhage >grade 2
Has a seizure disorder not related to drug withdrawal
Has a clinically significant cardiac shunt
Has anemia (hemoglobin<8g/dL)
Requires mechanical respiratory support
Has MRSA or infection at time of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes

Read the detailed description

This study will test the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological treatment and hospitalization, and for improving neurobehavioral developmental outcomes in opioid-exposed newborns.

Candidates at-risk for NAS due opioid exposure in utero will be identified to investigators by medical caregiver and/or prescreened using HIPAA Waiver for recruitment (maternal-prenatal; infant-postnatal). Infants will be randomized into either SVS (complementary to standard of care) or Treatment as Usual (TAU), restricted by equipment (mattress) availability. Infants will be enrolled and assigned to a condition within 48 hours post birth and participate throughout hospitalization. Infants assigned SVS will receive daily intervention of continuous intervals of SVS throughout hospitalization using a specially constructed crib mattress that delivers gentle vibrations at preset intervals.

Specific Aim 1. Determine the efficacy of SVS as a non-pharmacological therapy complementary to standard of care for reducing severity and duration of opioid withdrawal in newborns compared to TAU alone. Quantify clinical variables: NAS severity, treatment days, days in hospital, velocity of weight gain, cumulative morphine dose.

Specific Aim 2. Compare neurobehavioral outcomes in fetal drug-exposed infants between infants who received SVS and those who received TAU. Longitudinal outcomes assessment at 6-months and 1 year to test whether early intervention with SVS compared to standard care improves physical, social, emotional and cognitive development.

Conditions: Neonatal Abstinence Syndrome
Being tested: Stochastic Vibrotactile Stimulation (SVS)
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
Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.

Study groups in NCT02801331
Study group	Role	What they receive
Stochastic Vibrotactile Stimulation (SVS)	Experimental	Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed). Receives: Device: Stochastic Vibrotactile Stimulation (SVS)
Treatment as Usual (TAU)	No intervention	Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Administered Morphine Treatment
Number of infants treated with morphine (first line pharmacotherapy at both sites).
Number of infants who received pharmacotherapy (met clinical criteria to treat), index of NAS severity (per Finnegan scores).
Measured: Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days
Cumulative Pharmacological Treatment- Morphine Dose
Normalized cumulative morphine dose for infants who completed treatment at respective hospital site (mg/kg).
Measured: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Hospitalization Length of Stay
Day of life discharged home for untreated and treated infants who completed hospitalization at study site.
Duration of infant hospitalization-Days
Measured: Day of life infants discharged home, which is an expected mean of 21 days.
Hospitalization Length of Stay for Untreated Infants
Day of life discharged home for untreated infants (infants whose Finnegan scores did not meet criteria to treat) who completed hospitalization at study site.
Duration of infant hospitalization-Days
Measured: Day of life untreated infants discharged home, which is an expected mean of 21 days.
Hospitalization Length of Stay for Treated Infants
Day of life discharged home for treated infants (infants whose Finnegan scores met criteria to treat) who completed hospitalization at study site.
Duration of infant hospitalization-Days
Measured: Day of life treated infants discharged home, which is an expected mean of 21 days.
Length of Pharmacological Treatment-Duration
For infants who received pharmacotherapy, total days of morphine treatment.
Measured: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Trajectory of Symptom Severity Among Treated Infants
Days to start morphine treatment based on Finnegan severity scores among infants who met clinical criteria to treat
Measured: Day of life infant started morphine treatment
Velocity of Weight Gain
Weight loss precedes weight gain in newborns. Days to weight nadir, defined as the lowest weight following birthweight. Velocity of weight gain was measured as days to return to birthweight, i.e., the day on which weight reached or surpassed birthweight following initial weight loss from birth.
Measured: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Neurobehavioral Outcomes Assessment
Scores for Cognitive Domain Bayley Scales of Infant and Toddler Development Third Edition. The standardized scores have a mean of 100 and standard deviation (SD) of 15. Scores below 1 SD (= or less than 84) is considered below normal. Scores above 1 SD (>115) represent higher than normal functioning.
Measured: 6 month and 12 months of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 20176 Jun 2021

First posted15 Jun 2016 (estimated)
Study start9 Mar 2017
Primary completion5 Mar 2021
Study completion6 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02801331
Sponsor's protocol ID: STUDY21040054
Other IDs: 1R01DA042074-01
Status last verified: May 2025
First submitted: 9 Jun 2016
Last updated: 11 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Bloch-Salisbury E, Bogen D, Vining M, Netherton D, Rodriguez N, Bruch T, Burns C, Erceg E, Glidden B, Ayturk D, Aurora S, Yanowitz T, Barton B, Beers S. Study design and rationale for a randomized controlled trial to assess effectiveness of stochastic vibrotactile mattress stimulation versus standard non-oscillating crib mattress for treating hospitalized opioid-exposed newborns. Contemp Clin Trials Commun. 2021 Feb 11;21:100737. doi: 10.1016/j.conctc.2021.100737. eCollection 2021 Mar.
PubMed 33748529
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 35636580
Liu VY, Flahive JM, Bloch-Salisbury E. Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed Newborns. J Nurs Meas. 2024 Oct 24;32(3):467-476. doi: 10.1891/JNM-2023-0020.
PubMed 37353324
Bloch-Salisbury E, Wilson JD, Rodriguez N, Bruch T, McKenna L, Derbin M, Glidden B, Ayturk D, Aurora S, Yanowitz T, Barton B, Vining M, Beers SR, Bogen DL. Efficacy of a Vibrating Crib Mattress to Reduce Pharmacologic Treatment in Opioid-Exposed Newborns: A Randomized Clinical Trial. JAMA Pediatr. 2023 Jul 1;177(7):665-674. doi: 10.1001/jamapediatrics.2023.1077.
PubMed 37184872
Bloch-Salisbury E, Rodriguez N, Bruch T, McKenna L, Derbin M, Netherton D, Yanowitz T, Beers SR, Vining M, Wilson JD. Stochastic vibration and early weight growth in opioid-exposed newborns: a randomized trial. J Perinatol. 2026 Aug 24. doi: 10.1038/s41372-026-02862-z. Online ahead of print.
PubMed 42637897
Pahl 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome

All Neonatal Abstinence Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Study of Stochastic Vibrotactile Stimulation for Neonatal Abstinence Syndrome: Therapeutic Efficacy and Neurobehavioral Outcomes
ClinicalTrials.gov ID: NCT02801331
Acronym / sponsor ID: STUDY21040054
Conditions: Neonatal Abstinence Syndrome
Keywords: Stochastic Resonance, Fetus/Newborn Infant, Drug Withdrawal, Substance Abuse
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: Elisabeth B SalisburyUniversity, hospital or other
Collaborators: University of Pittsburgh, National Institute on Drug Abuse (NIDA), University of Massachusetts, Worcester
Study start: 9 Mar 2017 (actual)
Primary completion: 5 Mar 2021 (actual)
Study completion: 6 Jun 2021 (actual)
First posted: 15 Jun 2016 (estimated)
Results: Posted 23 May 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Stochastic Vibrotactile Stimulation (SVS)	Experimental	Device: Stochastic Vibrotactile Stimulation (SVS)Infants randomized to this arm will receive daily intervals of continuous SVS (ON) and no SVS (OFF) throughout hospitalization, starting within 48-hrs post birth. SVS will be complementary to standard of clinical care (e.g., clinically-determined pharmacological management; routine parental/volunteer holding; breast and/or bottle feed).
Treatment as Usual (TAU)	No intervention	–Infants randomized to this arm will be enrolled within 48-hours post birth and receive treatment as usual (TAU)- standard of clinical care (e.g., clinically-determined pharmacological management, routine/volunteer holding; breast and/or bottle feed). Infants will not receive any SVS.

Who may qualify

Ages: 1 hour to 18 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

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)Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle, stochastic vibration during mattress stimulations.	Device	Stochastic Vibrotactile Stimulation (SVS)

Primary outcome

Number of Participants Administered Morphine Treatment
Time frame: Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days
Number of infants treated with morphine (first line pharmacotherapy at both sites). Number of infants who received pharmacotherapy (met clinical criteria to treat), index of NAS severity (per Finnegan scores).
Cumulative Pharmacological Treatment- Morphine Dose
Time frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Normalized cumulative morphine dose for infants who completed treatment at respective hospital site (mg/kg).
Hospitalization Length of Stay
Time frame: Day of life infants discharged home, which is an expected mean of 21 days.
Day of life discharged home for untreated and treated infants who completed hospitalization at study site. Duration of infant hospitalization-Days
Hospitalization Length of Stay for Untreated Infants
Time frame: Day of life untreated infants discharged home, which is an expected mean of 21 days.
Day of life discharged home for untreated infants (infants whose Finnegan scores did not meet criteria to treat) who completed hospitalization at study site. Duration of infant hospitalization-Days
Hospitalization Length of Stay for Treated Infants
Time frame: Day of life treated infants discharged home, which is an expected mean of 21 days.
Day of life discharged home for treated infants (infants whose Finnegan scores met criteria to treat) who completed hospitalization at study site. Duration of infant hospitalization-Days
Length of Pharmacological Treatment-Duration
Time frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
For infants who received pharmacotherapy, total days of morphine treatment.
Trajectory of Symptom Severity Among Treated Infants
Time frame: Day of life infant started morphine treatment
Days to start morphine treatment based on Finnegan severity scores among infants who met clinical criteria to treat
Velocity of Weight Gain
Time frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days
Weight loss precedes weight gain in newborns. Days to weight nadir, defined as the lowest weight following birthweight. Velocity of weight gain was measured as days to return to birthweight, i.e., the day on which weight reached or surpassed birthweight following initial weight loss from birth.
Neurobehavioral Outcomes Assessment
Time frame: 6 month and 12 months of life
Scores for Cognitive Domain Bayley Scales of Infant and Toddler Development Third Edition. The standardized scores have a mean of 100 and standard deviation (SD) of 15. Scores below 1 SD (= or less than 84) is considered below normal. Scores above 1 SD (>115) represent higher than normal functioning.

Results and safety

Results posted to the registry on 23 May 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stochastic Vibrotactile Stimulation (SVS)	105	94
Treatment as Usual (TAU)	103	87

Primary outcome: Number of Participants Administered Morphine Treatment

Time frame: Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days. Count of participants. Unit: Participants

Measure	Stochastic Vibrotactile Stimulation (SVS) n = 94	Treatment as Usual (TAU) n = 87
Value	29	31

Stochastic Vibrotactile Stimulation (SVS) vs Treatment as Usual (TAU): p = .60, Chi-squared

Population analysed: Analyzed infants: completed hospitalization at respective study site

Primary outcome: Cumulative Pharmacological Treatment- Morphine Dose

Time frame: Participants will be monitored for the duration of their hospitalization, which is an expected mean of 21 days. Mean (Standard Deviation). Unit: mg/kg

Measure	Stochastic Vibrotactile Stimulation (SVS) n = 29	Treatment as Usual (TAU) n = 31
Value	7.3 (6.6)	8.2 (7.5)

Stochastic Vibrotactile Stimulation (SVS) vs Treatment as Usual (TAU): p = .62, t-test, 2 sided

Population analysed: Analyzed cohort who received morphine treatment

Primary outcome: Hospitalization Length of Stay

Time frame: Day of life infants discharged home, which is an expected mean of 21 days.. Mean (Standard Deviation). Unit: day of life discharged home

Measure	Stochastic Vibrotactile Stimulation (SVS) n = 94	Treatment as Usual (TAU) n = 87
Value	11.5 (11.0)	13.5 (14.6)

Stochastic Vibrotactile Stimulation (SVS) vs Treatment as Usual (TAU): p = 0.29, t-test, 2 sided

Population analysed: Untreated and treated infants who completed hospitalization at study site.

Primary outcome: Hospitalization Length of Stay for Untreated Infants

Time frame: Day of life untreated infants discharged home, which is an expected mean of 21 days.. Mean (Standard Deviation). Unit: day of life discharged home

Measure	Stochastic Vibrotactile Stimulation (SVS) n = 65	Treatment as Usual (TAU) n = 56
Value	5.9 (1.6)	5.7 (1.3)

Stochastic Vibrotactile Stimulation (SVS) vs Treatment as Usual (TAU): p = 0.55, t-test, 2 sided

Adverse events

Time frame: All-Cause Mortality, Serious and Other adverse events (AE) were obtained for up to 14 months; includes in-hospital and reports obtained post-hospital discharge throughout the follow-up period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stochastic Vibrotactile Stimulation (SVS)	1 of 105 (1%)	0 of 105 (0%)	0 of 105
Treatment as Usual (TAU)	1 of 103 (1%)	0 of 103 (0%)	1 of 103

Limitations and caveats (from the sponsor): Enrollment closed at 208 infants before reaching proposed enrollment of 220 infants due to the administration at UMass reneging support for the project, requiring close out at UMass site. PI and funding support were transferred to complete the project at the UPitt site. Delays in reporting reflect transfer-related project restructuring and reduction in study personnel.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 33748529Bloch-Salisbury E, Bogen D, Vining M, Netherton D, Rodriguez N, Bruch T, Burns C, Erceg E, Glidden B, Ayturk D, Aurora S, Yanowitz T, Barton B, Beers S. Study design and rationale for a randomized controlled trial to assess effectiveness of stochastic vibrotactile mattress stimulation versus standard non-oscillating crib mattress for treating hospitalized opioid-exposed newborns. Contemp Clin Trials Commun. 2021 Feb 11;21:100737. doi: 10.1016/j.conctc.2021.100737. eCollection 2021 Mar.
Background: 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.
Background: PubMed 37353324Liu VY, Flahive JM, Bloch-Salisbury E. Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed Newborns. J Nurs Meas. 2024 Oct 24;32(3):467-476. doi: 10.1891/JNM-2023-0020.
Results publication: PubMed 37184872Bloch-Salisbury E, Wilson JD, Rodriguez N, Bruch T, McKenna L, Derbin M, Glidden B, Ayturk D, Aurora S, Yanowitz T, Barton B, Vining M, Beers SR, Bogen DL. Efficacy of a Vibrating Crib Mattress to Reduce Pharmacologic Treatment in Opioid-Exposed Newborns: A Randomized Clinical Trial. JAMA Pediatr. 2023 Jul 1;177(7):665-674. doi: 10.1001/jamapediatrics.2023.1077.
Derived from this study: PubMed 42637897Bloch-Salisbury E, Rodriguez N, Bruch T, McKenna L, Derbin M, Netherton D, Yanowitz T, Beers SR, Vining M, Wilson JD. Stochastic vibration and early weight growth in opioid-exposed newborns: a randomized trial. J Perinatol. 2026 Aug 24. doi: 10.1038/s41372-026-02862-z. Online ahead of print.
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.
Study design and rationale for a randomized controlled trial to assess effectiveness...Link provided by the sponsor.
Physiologic dysregulation in newborns with prenatal opioid exposure: Cardiac, respiratory and movement activityLink provided by the sponsor.
Efficacy of a Vibrating Crib Mattress to Reduce Pharmacologic Treatment in Opioid-Exposed Newborns: A Randomized Clinical TrialLink provided by the sponsor.
Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed NewbornsLink provided by the sponsor.
Individual participant dataSharing planned: No

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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 Pittsburgh

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 Elisabeth B Salisbury 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?

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 11 Jun 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?

Yes. Results are posted in the registry (first posted 23 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Administered Morphine Treatment (time frame: Participants will be monitored for the duration of their newborn nursery stay, which is an expected mean of 7 days). The study lists 9 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 NCT02801331, which also lists 6 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 11 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.