Clinical Trial: Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Physiology and Therapeutic Management of Neonatal Abstinence Syndrome

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 Summary:

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 Attending physician. 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.


Sponsor: University of Massachusetts, Worcester

Current Primary Outcome:

  • Investigate effects of SVS vs no SVS on changes in movement activity at different stages of withdrawal. [ Time Frame: Infants may participate in up to 8 physiology recording sessions throughout hospitalization. Each study session may last up to 24 hours. ]
    Focus on movement duration (e.g., prolonged movements >30sec).
  • Investigate effects of SVS vs no SVS on changes in breathing patterns at different stages of withdrawal. [ Time Frame: Infants may participate in up to 8 physiology recording sessions throughout hospitalization. Each study session may last up to 24 hours. ]
    Focus on respiratory rate.
  • Investigate efects of SVS vs no SVS on changes in cardiac activity at different stages of withdrawal. [ Time Frame: Infants may participate in up to 8 physiology recording sessions throughout hospitalization. Each study session may last up to 24 hours. ]
    Focus on heart rate.


Original Primary Outcome:

  • Compare effects of SVS vs no SVS on changes in movement activity at different stages of withdrawal. [ Time Frame: Infants may participate in up to 8 physiology recording sessions throughout hospitalization. Each study session may last up to 24 hours. ]
    Focus on movement duration (e.g., prolonged movements >30sec).
  • Compare effects of SVS vs no SVS on changes in breathing patterns at different stages of withdrawal. [ Time Frame: Infants may participate in up to 8 physiology recording sessions throughout hospitalization. Each study session may last up to 24 hours. ]
    Focus on respiratory rate.
  • Compare effects of SVS vs no SVS on changes in cardiac activity at different stages of withdrawal. [ Time Frame: Infants may participate in up to 8 physiology recording sessions throughout hospitalization. Each study session may last up to 24 hours. ]
    Focus on heart rate.


Current Secondary Outcome: Effects of SVS vs no SVS on changes in thermoregulation at different stages of withdrawal. [ Time Frame: Infants may participate in up to 8 physiology recording sessions throughout hospitalization. Each study session may last up to 24 hours. ]

Focus on stability of axillary temperature.


Original Secondary Outcome: Compare effects of SVS vs no SVS on changes in thermoregulation at different stages of withdrawal. [ Time Frame: Infants may participate in up to 8 physiology recording sessions throughout hospitalization. Each study session may last up to 24 hours. ]

Focus on stability of axillary temperature.


Information By: University of Massachusetts, Worcester

Dates:
Date Received: May 2, 2016
Date Started: April 2011
Date Completion: June 2017
Last Updated: March 13, 2017
Last Verified: March 2017