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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.
This study will test the therapeutic efficacy of stochastic vibrotactile stimulation (SVS) for reducing withdrawal symptoms, pharmacological requirement 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 the primary care physician (maternal-prenatal; infant-postnatal). Infants will be randomized into either SVS (complementary to standard of care) or Standard Clinical Care (SCC), restricted by equipment (mattress) availability. Infants will be enrolled within 24 hours post birth and participate throughout hospitalization. Infants assigned SVS will receive daily intervention of continuous 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 clinical care (SCC) for reducing severity and duration of opioid withdrawal in newborns compared to SCC alone. Quantify clinical variables: NAS severity, 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 SCC. Longitudinal outcomes assessment at 1 month, 6-months and 1 year to test whether early intervention with SVS compared to standard care improves physical, social, emotional and cognitive development.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Neonatal Abstinence Syndrome
Stochastic Vibrotactile Stimulation (SVS)
Not yet recruiting
University of Massachusetts, Worcester
Published on BioPortfolio: 2016-06-15T17:53:22-0400
The overall purpose of this project is to to quantify the physiology of neonatal drug withdrawal and develop non-pharmacological techniques to help improve the therapeutic management of Ne...
Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium....
Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome
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To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) th...
To critically appraise and synthesize existing studies on the relationship between newborn feeding method and neonatal outcomes related to neonatal abstinence syndrome (NAS).
To validate the diagnostic discharge coding of Neonatal Abstinence Syndrome (NAS) (International Classification of Diseases (ICD)-10-AM, P96.1).
Opiate use during pregnancy has been an increasing problem over the last two decades, making it an important social and health concern. The use of such substances may have serious negative outcomes in...
To identify factors associated with referral and enrollment in early intervention (EI) for infants with neonatal abstinence syndrome (NAS).
Neonatal abstinence syndrome (NAS) is a group of problems associated with withdrawal symptoms of a newborn who was exposed to maternal opiate use while in the womb. West Virginia (WV) is of utmost con...
Fetal and neonatal addiction and withdrawal as a result of the mother's dependence on drugs during pregnancy. Withdrawal or abstinence symptoms develop shortly after birth. Symptoms exhibited are loud, high-pitched crying, sweating, yawning and gastrointestinal disturbances.
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Congenital or postnatal overgrowth syndrome most often in height and occipitofrontal circumference with variable delayed motor and cognitive development. Other associated features include advanced bone age, seizures, NEONATAL JAUNDICE; HYPOTONIA; and SCOLIOSIS. It is also associated with increased risk of developing neoplasms in adulthood. Mutations in the NSD1 protein and its HAPLOINSUFFICIENCY are associated with the syndrome.
Yellow discoloration of the SKIN; MUCOUS MEMBRANE; and SCLERA in the NEWBORN. It is a sign of NEONATAL HYPERBILIRUBINEMIA. Most cases are transient self-limiting (PHYSIOLOGICAL NEONATAL JAUNDICE) occurring in the first week of life, but some can be a sign of pathological disorders, particularly LIVER DISEASES.
Stimulation of the brain, which is self-administered. The stimulation may result in negative or positive reinforcement.
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