Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Neonatal Abstinence Syndrome (NAS).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVS vs Control | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stochastic Vibrotactile Stimulation (SVS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infant Movement between Mattress ON and Mattress OFF (control) | Measure mean change in infant movement activity via limb sensors | Single sessions throughout course of hospitalization. Each session may last up to 24 hours. |
| Change in Infant Breathing between Mattress ON and Mattress OFF (control) | Measure mean change in infant respiratory rate via respiratory inductance plethysmography (RIP) | Single sessions throughout course of hospitalization. Each session may last up to 24 hours. |
| Change in Infant Heart Rate between Mattress ON and Mattress OFF(control) | Measure mean change in infant heart rate via Electrocardiography (ECG). | Single sessions throughout course of hospitalization. Each session may last up to 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Infant Temperature between Mattress ON and Mattress OFF (control) | Measure mean change in axillary temperature via temperature sensor. | Single session throughout course of hospitalization. Each session may last up to 24 hours. |
Not provided
Inclusion Criteria:
Eligible subjects are infants currently inpatient in the NICU or Newborn Nursery at University of Massachusetts Memorial Hospital and:
Exclusion Criteria:
Eligible infants meeting the inclusion criteria above will be excluded from participation in the study if he/she:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elisabeth B Salisbury, Ph.D. | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35636580 | Derived | 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. | |
| 33348423 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| D013375 | Substance Withdrawal Syndrome |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Control | Other | Absence of mattress Stochastic Vibratory Stimulation (SVS) |
|