N/A
N=208
Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome
Neonatal Abstinence Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02801331 ↗Enrolled (actual)
208
Serious AEs
1.0%
Results posted
May 2024
Primary outcome: Primary: Number of Participants Administered Morphine Treatment — 29; 31 Participants — p=.60
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stochastic Vibrotactile Stimulation (SVS) (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Elisabeth B Salisbury
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Administered Morphine Treatment |
29; 31 | .60 |
| PRIMARY Cumulative Pharmacological Treatment- Morphine Dose |
7.3; 8.2 | .62 |
| PRIMARY Hospitalization Length of Stay |
11.5; 13.5 | 0.29 |
| PRIMARY Hospitalization Length of Stay for Untreated Infants |
5.9; 5.7 | 0.55 |
| PRIMARY Hospitalization Length of Stay for Treated Infants |
24.1; 27.7 | 0.36 |
| PRIMARY Length of Pharmacological Treatment-Duration |
19.9; 21.6 | 0.56 |
| PRIMARY Trajectory of Symptom Severity Among Treated Infants |
2.5; 2.9 | 0.25 |
| PRIMARY Velocity of Weight Gain |
4.98; 5.05; 12.38; 13.48 | — |
| PRIMARY Neurobehavioral Outcomes Assessment |
99.1; 98.1; 101.5; 98.8 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02801331). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.