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
Access full-text PDFOpen Access
Check access options
Check access options
AuthorsSalisbury, Elisabeth B.
Vining, Mark A.
Ayturk, M. Didem
Barton, Bruce A.
UMass Chan AffiliationsDepartment of Population and Quantitative Health Sciences
Department of Pediatrics
Document TypeJournal Article
Electronic Medical Record
Infant drug withdrawal
Maternal substance use during pregnancy
Neonatal Abstinence Syndrome
Neonatal Intensive Care Unit
Neonatal abstinence syndrome
Neonatal opioid withdrawal syndrome
Stochastic vibrotactile stimulation (intervention-mattress condition)
Treatment as usual (control condition)
UMass Memorial Healthcare (Coordinating/Primary study site)
University of Pittsburgh (Consortium study site)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Substance Abuse and Addiction
MetadataShow full item record
AbstractThe incidence of Neonatal Abstinence Syndrome (NAS) continues to rise and there remains a critical need to develop non-pharmacological interventions for managing opioid withdrawal in newborns. Objective physiologic markers of opioid withdrawal in the newborn remain elusive. Optimal treatment strategies for improving short-term clinical outcomes and promoting healthy neurobehavioral development have yet to be defined. This dual-site randomized controlled trial (NCT02801331) is designed to evaluate the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological treatment, and length of hospitalization, and for improving developmental outcomes in opioid-exposed neonates. Hospitalized newborns (n = 230) receiving standard clinical care for prenatal opioid exposure will be randomly assigned within 48-hours of birth to a crib with either: 1) Intervention (SVS) mattress: specially-constructed SVS crib mattress that delivers gentle vibrations (30-60 Hz, ~12 mum RMS surface displacement) at 3-hr intervals; or 2) Control mattress (treatment as usual; TAU): non-oscillating hospital-crib mattress. Infants will be studied throughout their hospitalization and post discharge to 14-months of age. The study will compare clinical measures (i.e., withdrawal scores, cumulative dose and duration of medications, velocity of weight gain) and characteristic progression of physiologic activity (i.e., limb movement, cardio-respiratory, temperature, blood-oxygenation) throughout hospitalization between opioid-exposed infants who receive SVS and those who receive TAU. Developmental outcomes (i.e., physical, social, emotional and cognitive) within the first year of life will be evaluated between the two study groups. Findings from this randomized controlled trial will determine whether SVS reduces in-hospital severity of NAS, improves physiologic function, and promotes healthy development.
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. PMID: 33748529; PMCID: PMC7960539. Link to article on publisher's site
Permanent Link to this Itemhttp://hdl.handle.net/20.500.14038/29743
RightsCopyright © 2021 The Authors. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Except where otherwise noted, this item's license is described as Copyright © 2021 The Authors. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Showing items related by title, author, creator and subject.
A Quality Improvement Initiative to Increase Scoring Consistency and Accuracy of the Finnegan Tool: Challenges in Obtaining Reliable Assessments of Drug Withdrawal in Neonatal Abstinence SyndromeTimpson, Wendy; Killoran, Cheryl; Maranda, Louise; Picarillo, Alan; Bloch-Salisbury, Elisabeth (2017-10-17)BACKGROUND: Current practice for diagnosing neonatal abstinence syndrome and guiding pharmacological management of neonatal drug withdrawal is dependent on nursing assessments and repeated evaluation of clinical signs. PURPOSE: This single-center quality improvement initiative was designed to improve accuracy and consistency of Finnegan scores among neonatal nurses. METHODS: One-hundred seventy neonatal nurses participated in a single-session withdrawal-assessment program that incorporated education, scoring guidelines, and a restructured Finnegan scale. Nurses scored a standardized video-recorded infant presenting with opioid withdrawal before and after training. RESULTS: Nearly twice as many nurses scored at target (Finnegan score of 8) posttraining (34.7%; mean error = 0.559, SD = 1.4) compared with pretraining (18.8%; mean error = 1.31, SD = 1.95; Wilcoxon, P < .001). Finnegan scores were significantly higher than the target score pretraining (mean = 9.31, SD = 1.95) compared with posttraining (mean = 8.56, SD = 1.40, Wilcoxon P < .001); follow-up assessments reverted to pretraining levels (mean = 9.16, SD = 1.8). Score dispersion was greater pretraining (variance 3.80) compared with posttraining (variance 1.96; Kendall's Coefficient, P < .001) largely due to score disparity among central nervous system symptomology. IMPLICATIONS FOR PRACTICE: Education, clinical guidelines, and a restructured scoring tool increased consistency and accuracy of infant withdrawal-assessments among neonatal nurses. However, more than 60% of nurses did not assess withdrawal to the target score immediately following the training period and improvements did not persist over time. IMPLICATIONS FOR RESEARCH: This study highlights the need for more objective tools to quantify withdrawal severity given that assessments are the primary driver of pharmacological management in neonatal drug withdrawal.
Neonatal Resuscitation and Quality Improvement initiatives at Hopital St Nicolas de Saint Marc, HaitiO’Dowd, Deborah (2018-03-09)According to statistics drawn from the World Health Organization, Haiti has one of the highest infant mortality rates in the Americas, at 52.2 per 1,000 live births as compared to 12.5 per 1,000 live births in the Americas overall (World Health Organization, 2016). One of the key factors in improving these numbers is to improve the availability and quality of care. Providing advanced education to Haitian nursing staff regarding the care of neonates is vital to improving the outcomes of this patient population. Additionally, providing a strong foundation in quality improvement methodology gives the nurses the tools they need to develop and implement their own quality improvement initiatives. In a collaborative education project with Partners in Health, a quality improvement formation was introduced at Hôpital St Nicolas de Saint Marc, in Saint Marc, Haiti. Additionally, the team taught two formations of neonatal resuscitation, with 18 and 19 nurses respectively, to help provide the nurses with the tools they need to utilize evidence based best practice at deliveries. Follow up in October included the introduction of an additional group of practitioners to QI methodology, and the groups are now being mentored through the development and implementation of independent projects.
Decision-making process for conditions nominated to the recommended uniform screening panel: statement of the US Department of Health and Human Services Secretary's Advisory Committee on Heritable Disorders in Newborns and ChildrenKemper, Alex R.; Green, Nancy S.; Calonge, Ned; Lam, Wendy K.K.; Comeau, Anne Marie; Goldenberg, Aaron J.; Ojodu, Jelili; Prosser, Lisa A.; Tanksley, Susan; Bocchini, Joseph A. Jr. (2014-02-01)PURPOSE: The US Secretary of Health and Human Services provides guidance to state newborn screening programs about which conditions should be included in screening (i.e., the "Recommended Uniform Screening Panel"). This guidance is informed by evidence-based recommendations from the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children. This report describes the Advisory Committee's revised decision-making process for considering conditions nominated to the panel. METHODS: An expert panel meeting was held in April 2012 to revise the decision matrix, which helps to guide the recommendation process. In January 2013, the Advisory Committee voted to adopt the revised decision matrix. RESULTS: The revised decision matrix clarifies the approach to rating magnitude and certainty of the net benefit of screening to the population of screened newborns for nominated conditions, and now includes the consideration of the capability of state newborn screening programs for population-wide implementation by evaluating the feasibility and readiness of states to adopt screening for nominated conditions. CONCLUSION: The revised decision matrix will bring increased quality, transparency, and consistency to the process of modifying the recommended uniform screening panel and will now allow formal evaluation of the challenges that state newborn screening programs face in adopting screening for new conditions.