Interventions to Help Infants Recover in the Hospital

• ClinicalTrials.gov Identifier: NCT03881553
• Recruitment Status: Terminated
• First Posted: March 19, 2019
• Last Update Posted: December 14, 2020
• Sponsor: Elisabeth Salisbury
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Elisabeth Salisbury, University of Massachusetts, Worcester

Tracking Information

• First Submitted Date: March 3, 2019
• First Posted Date: March 19, 2019
• Last Update Posted Date: December 14, 2020
• Actual Study Start Date: July 19, 2019
• Actual Primary Completion Date: March 7, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 18, 2019)

• Sleep duration with and without intervention [ Time Frame: Change in sleep duration will be assessed for up to 24 hours during which the intervention was on and off ]
  Percent Sleep vs Percent Wake duration
• Respiratory Events with and without intervention [ Time Frame: Change in respiratory events will be assessed for up to 24 hours during which the intervention was on and off ]
  Percent Respiratory Events (e.g., apnea, tachypnea)
• Cardiac Events with and without intervention [ Time Frame: Change in cardiac events will be assessed for up to 24 hours during which the intervention was on and off ]
  Percent cardiac events (e.g., tachycardia, bradycardia)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 18, 2019)

Sleep Quality with and without intervention [ Time Frame: Change in sleep states will be assessed for up to 24 hours during which the intervention was on and off ]

Percent Sleep Stage (e.g., Active, Quiet, Indeterminate, Wake)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Interventions to Help Infants Recover in the Hospital
• Official Title: Interventions to Help Infants and Children Recover in the Hospital
• Brief Summary: This pilot project will evaluate independently two non-pharmacological interventions, 1) Neurosensory, Environmental Adaptive Technology (NEATCAP) and 2) Stochastic Vibrotactile Stimulation (SVS), as adjuvant non-pharmacological interventions for improving sleep and cardio-respiratory function in hospitalized infants. Within-subject design allows subjects to serve as their own control and receive periods of routine care with and without intervention. One intervention will be evaluated per study session. Infants may participate in up to four sessions.

Detailed Description

Infants and children treated in the hospital often present with autonomic and sleep disturbances that may be related to prematurity, opioid and other drug exposures in utero, illness, surgery, medical procedures, and/or treatment medications. In addition, patients treated in neonatal and pediatric units often require prolonged hospitalization with medical monitoring and life-sustaining devices equipped with patient safety alarms. Such bedside equipment may result in patients being exposed to loud and/or persistent noises that may further disrupt sleep and autonomic function and compromise recovery and outcomes.

This pilot study will study three separate pediatric populations being treated in neonatal and pediatric hospital units: 1) Premature Infants; 2) Opioid-exposed newborns requiring medication for Neonatal Abstinence Syndrome; and 3) Hospitalized infants treated for illness or surgery. Subjects will participate in up to 4 study sessions during their hospitalization, testing independent effects of two interventions complementary to routine care: 1) Neurosensory, Environmental Adaptive Technology (NEATCAP), and 2) stochastic vibrotactile stimulation (SVS). Within-subject design will allow for comparisons between periods, i.e., with and without the study-session intervention, separately for each device, for improving sleep and cardio-respiratory function in three independent groups of hospitalized infants.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Within-subjects design. Each subject will serve as own control and receive periods of intervention and no intervention within a study session.

Masking: None (Open Label)
Primary Purpose: Basic Science

Condition

• Infant Apnea
• Neonatal Abstinence Syndrome
• Sleep

Intervention

• Device: NEATCAP
  NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.
  Other Name: NEATCAP DREAMIES (NEATCap Medical, LLC)
• Device: SVS mattress
  SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation.

Study Arms

• Experimental: Premature Infants (NICU)
  Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) will participate in up to 2 sessions with NEATCAP intervention and up to 2 sessions with SVS mattress intervention.
  Interventions:

  • Device: NEATCAP
  • Device: SVS mattress
• Experimental: Opioid-Exposed Newborns (NICU)
  Opioid-exposed newborns receiving care in the Neonatal Intensive Care Unit (NICU) will participate in up to 2 sessions with NEATCAP intervention and up to 2 sessions with SVS mattress intervention.
  Interventions:

  • Device: NEATCAP
  • Device: SVS mattress
• Experimental: Hospitalized Infants (PICU)
  Infants receiving treatment in the Pediatric Intensive Care or Inpatient Unit will participate in up to 2 sessions with NEATCAP intervention and up to 2 sessions with SVS mattress intervention.
  Interventions:

  • Device: NEATCAP
  • Device: SVS mattress

Publications *

• Zuzarte I, Indic P, Barton B, Paydarfar D, Bednarek F, Bloch-Salisbury E. Vibrotactile stimulation: A non-pharmacological intervention for opioid-exposed newborns. PLoS One. 2017 Apr 20;12(4):e0175981. doi: 10.1371/journal.pone.0175981. eCollection 2017.
• Bloch-Salisbury E, Indic P, Bednarek F, Paydarfar D. Stabilizing immature breathing patterns of preterm infants using stochastic mechanosensory stimulation. J Appl Physiol (1985). 2009 Oct;107(4):1017-27. doi: 10.1152/japplphysiol.00058.2009. Epub 2009 Jul 16.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 10, 2020): 14
• Original Estimated Enrollment (submitted: March 18, 2019): 15
• Actual Study Completion Date: March 7, 2020
• Actual Primary Completion Date: March 7, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Pre-term infants (>30 wks PMA) and full-term newborns receiving care since birth in the NICU/CCN.
• Infants/Children receiving care in the PICU/PIU (may have had a history of prematurity).
• May be with or without in utero opioid exposure and/or other drug exposure (prescribed or illicit).
• May have received or be receiving opioids and/or other treatment medications as part of their medical-care plan.
• Infants and children on respiratory support and/or with medical complications will not be excluded if these complications are potentially reversible.

Exclusion Criteria:

• Congenital anomalies of the head and/or neck.
• Significant cranial trauma.
• Hydrocephalus.
• Current or history of intraventricular hemorrhage>grade 2.
• Clinically significant cardiac shunt.
• Hemodynamic instability requiring pharmacological intervention at time of study participation.
• Documented HIV and/or MRSA positivity requiring treatment at time of study participation.
• Seizure disorder not due to opioid withdrawal.
• Invasive ventilation at time of study participation.
• Recommendation of attending physician or primary medical caregiver not to enroll the patient for any reason.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Weeks to 5 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03881553
• Other Study ID Numbers: H00015487; U54HL143541 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Elisabeth Salisbury, University of Massachusetts, Worcester
• Study Sponsor: Elisabeth Salisbury
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Elisabeth Salisbury, PhD; UMass Medical School

• PRS Account: University of Massachusetts, Worcester
• Verification Date: December 2020