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
AuthorsSalisbury, Elisabeth B.
Vining, Mark A.
Ayturk, M. Didem
Barton, Bruce A.
UMass Chan AffiliationsDepartment of Population and Quantitative Health Sciences
Department of Pediatrics
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/).
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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.
The increased incidence of congenital hypothyroidism: fact or fancy?Mitchell, Marvin L.; Hsu, Ho-Wen; Sahai, Inderneel; Brink, Stuart J.; Brown, Rosalind S.; Cohen, Laurie E.; Eaton, Roger B.; Lee, Mary M.; Levitsky, Lynne L.; Reiter, Edward; et al. (2011-05-27)OBJECTIVE: The incidence of congenital hypothyroidism (CH) detected by newborn screening in the US has increased significantly since the early 1990s. We defined the characteristics associated with the increased incidence. PATIENTS: A cohort of children with CH born during an earlier period of low incidence (1991-94) was compared with a cohort born during a later period when the incidence of CH had doubled (2001-04). MEASUREMENTS: Screening was performed with T4 as the primary marker and thyroid stimulating hormone (TSH) on selected specimens. Follow-up on hypothyroid children determined whether they had permanent or transient hypothyroidism. Cases were classified based on laboratory results: initial TSH >/=100 mU/l was 'severe,' initial TSH /l but >/=20 mU/l was 'mild' and initial TSH /l with subsequent abnormal TSH was 'delayed'. RESULTS: The overall incidence of CH almost doubled between the two time periods, from 1:3010 to 1:1660. Excess cases were found in the mild and delayed categories, with no increase in severe cases. The proportion of transient cases was CONCLUSION: The rising incidence of CH in Massachusetts is confined to mild and delayed cases. Our findings suggest that this rise is attributable to enhanced detection rather than an absolute increase in numbers.