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

NCT02801331 | Completed Results DMC FDA Device

• 2 other identifiers: STUDY210400541R01DA042074-01
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Abstinence Syndrome

Keywords

Stochastic Resonance; Fetus/Newborn Infant; Drug Withdrawal; Substance Abuse

Outcome Measures

Primary Outcomes (9)

• 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).

  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).

  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

  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

  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

  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.

  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

  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.

  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.

  6 month and 12 months of life

Other Outcomes (1)

• Respiratory Rate

  Assess respiratory rate for about 12 consecutive hours at week 1 of infant hospitalization

Study Arms (2)

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).

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.

Interventions

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.

Stochastic Vibrotactile Stimulation (SVS)

Eligibility Criteria

• Age: 1 Hour - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Elisabeth B Salisbury: lead
• University of Pittsburgh: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• University of Massachusetts, Worcester: collaborator

Study Sites (1)

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (5)

• 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.

  PMID: 33748529 BACKGROUND

• 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.

  PMID: 35636580 BACKGROUND

• 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.

  PMID: 37353324 BACKGROUND

• 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.

  PMID: 37184872 RESULT

• 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.

  PMID: 33348423 DERIVED

Related Links

• Study design and rationale for a randomized controlled trial to assess effectiveness...
• Physiologic dysregulation in newborns with prenatal opioid exposure: Cardiac, respiratory and movement activity
• Actigraphy: An Adjunctive Method to Measure Irritability in Opioid-Exposed Newborns

MeSH Terms

Conditions

Neonatal Abstinence Syndrome; Substance Withdrawal Syndrome; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chemically-Induced Disorders; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Elisabeth B Salisbury, PhD
• Organization: University of Pittsburgh School of Medicine

salisburye2@upmc.edu

14122465378

Study Officials

• Elisabeth B Salisbury, Ph.D.

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Visiting Associate Professor

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 15, 2016
• Study Start: March 9, 2017
• Primary Completion: March 5, 2021
• Study Completion: June 6, 2021
• Last Updated: June 11, 2025
• Results First Posted: May 23, 2024

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)