Clinical trial NCT02768844: Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
Official title: Physiology and Therapeutic Management of Neonatal Abstinence Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Keywords: Stochastic Resonance
Fetus/Newborn Infant
Drug Withdrawal
Substance Abuse
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 46
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Infant Movement between Mattress ON and Mattress OFF (control)
timeFrame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
measure: Change in Infant Breathing between Mattress ON and Mattress OFF (control)
timeFrame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
measure: Change in Infant Heart Rate between Mattress ON and Mattress OFF(control)
timeFrame: Single sessions throughout course of hospitalization. Each session may last up to 24 hours.
Secondary outcomes:
measure: Change in Infant Temperature between Mattress ON and Mattress OFF (control)
timeFrame: Single session throughout course of hospitalization. Each session may last up to 24 hours.
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Elisabeth B Salisbury, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.