- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02768844
Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Novel approaches to diagnosing and treating Neonatal Abstinence Syndrome (NAS) are needed for reducing prolonged pharmacological management, minimizing hospitalization and improving developmental outcomes in drug exposed newborns. This study seeks to examine the physiology and symptoms of drug withdrawal (e.g., irritability marked by movement activity; cardio-respiratory instabilities) in infants exposed to drugs in utero and test whether sensory stimuli (tactile, auditory) reduce dysregulated systems in the withdrawing infant.
Candidates at-risk for NAS due to fetal drug exposure will be identified to investigators by the infant's primary medical caregiver. Investigators will use a modified-consecutive sampling technique, restricted by equipment and personnel availability, for enrolling infants. Participants will be studied throughout their hospitalization. Effects of stimulation will be examined at different stages of withdrawal. Efficacy of stimulation will be examined as a potential complementary treatment of NAS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Eligible subjects are infants currently inpatient in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital and:
- Full-term infants (>37 wks gestational age) and late preterm infants (34-37 wks gestational age)
- Newborns at risk for NAS due to fetal-drug exposure
- At-risk infants will be infants who present with confirmed meconium and/or urine toxicology report (documented in medical chart review) 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 <34 weeks.
- Has a congenital abnormality
- Has a fetal anomaly
- Has hydrocephalus or intraventricular hemorrhage >grade 2
- Has a seizure disorder not related to drug withdrawal
- Has a clinically significant shunt
- Requires mechanical respiratory support
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: SVS vs Control
Prospective, within-subject design.
Compare effects of mattress SVS (ON) and Control (SVS OFF) on physiology in opioid-exposed newborns.
SVS is alternated in intervals between continuous stimulation (ON) and no stimulation (OFF/Control) throughout inter-feed intervals.
The order of the ON-OFF cycles is randomized across subjects and counterbalanced between feeding periods within subjects.
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The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available; designed by Wyss Institute, Harvard University, Cofab Design LLC) to provide gentle vibrations and sounds during mattress stimulations.
Absence of mattress Stochastic Vibratory Stimulation (SVS)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Infant Movement between Mattress ON and Mattress OFF (control)
Time Frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
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Measure mean change in infant movement activity via limb sensors
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Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
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Change in Infant Breathing between Mattress ON and Mattress OFF (control)
Time Frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
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Measure mean change in infant respiratory rate via respiratory inductance plethysmography (RIP)
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Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
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Change in Infant Heart Rate between Mattress ON and Mattress OFF(control)
Time Frame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
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Measure mean change in infant heart rate via Electrocardiography (ECG).
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Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Infant Temperature between Mattress ON and Mattress OFF (control)
Time Frame: Single session throughout course of hospitalization. Each session may last up to 24 hours.
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Measure mean change in axillary temperature via temperature sensor.
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Single session throughout course of hospitalization. Each session may last up to 24 hours.
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Collaborators and Investigators
Investigators
- Principal Investigator: Elisabeth B Salisbury, Ph.D., University of Massachusetts, Worcester
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H00006578
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neonatal Abstinence Syndrome
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Indiana UniversityCompletedNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal Syndrome | Neonatal Opioid WithdrawalUnited States
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PediatrixCompletedNeonatal Abstinence Syndrome | Neonatal Withdrawal SyndromeUnited States
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Milton S. Hershey Medical CenterNational Institute on Drug Abuse (NIDA)RecruitingNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal SyndromeUnited States
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Tufts Medical CenterCompletedNeonatal Abstinence Syndrome | Neonatal Opioid WithdrawalUnited States
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Tulane UniversityRecruitingNeonatal Abstinence Syndrome | Substance Withdrawal, NeonatalUnited States
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University of VermontNational Institute on Drug Abuse (NIDA); Johns Hopkins University; University... and other collaboratorsCompletedOpioid-use Disorder | Neonatal Abstinence Syndrome | Opioid Withdrawal | Neonatal Opioid Withdrawal SyndromeUnited States
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University of AlbertaAlberta Health services; Alberta Innovates Health Solutions; Covenant HealthRecruitingNeonatal Abstinence SyndromeCanada
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University Hospital, CaenRecruitingNeonatal Abstinence SyndromeFrance
Clinical Trials on Stochastic Vibrotactile Stimulation (SVS)
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University of ArizonaVirginia Polytechnic Institute and State UniversityNot yet recruiting
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University of Colorado, DenverNot yet recruiting
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Donders Centre for Cognitive NeuroimagingParkinson's FoundationCompleted
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Marquette UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingStroke | Proprioceptive DisordersUnited States
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Stanford UniversityJohn A Blume FoundationCompleted
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University of DelawareRecruiting
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Stanford UniversitySuspendedLow Back Pain | Chronic Pain | Migraine | Pelvic Pain | Functional Abdominal Pain SyndromeUnited States
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National Yang Ming UniversityTaipei Veterans General Hospital, TaiwanUnknownHealthy | Stroke, IschemicTaiwan
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University of MinnesotaRecruiting