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Interventions to Help Infants Recover in the Hospital

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ClinicalTrials.gov Identifier: NCT03881553
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Elisabeth Salisbury, University of Massachusetts, Worcester

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.

Condition or disease Intervention/treatment Phase
Infant Apnea Neonatal Abstinence Syndrome Sleep Device: NEATCAP Device: SVS mattress Not Applicable

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) Critically-ill 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Official Title: Interventions to Help Infants and Children Recover in the Hospital
Estimated Study Start Date : August 15, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Premature Infants (NICU)
A convenience sample of 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.
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.

Experimental: Opioid-Exposed Newborns (NICU)
A convenience sample of 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.
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.

Experimental: Hospitalized Infants (PICU)
A convenience sample of 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.
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.




Primary Outcome Measures :
  1. 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

  2. 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)

  3. 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)


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Weeks to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881553


Contacts
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Contact: Elisabeth Salisbury, PhD 508-334-8627 elisabeth.salisbury@umassmed.edu

Locations
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United States, Massachusetts
UMass Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Elisabeth Salisbury
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Elisabeth Salisbury, PhD UMass Medical School

Additional Information:
Publications:
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Responsible Party: Elisabeth Salisbury, Research Associate Professor, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03881553     History of Changes
Other Study ID Numbers: H00015487
U54HL143541 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Elisabeth Salisbury, University of Massachusetts, Worcester:
Prematurity
Neonatal Abstinence Syndrome
Autonomic Function
Sleep
Stochastic Resonance
Newborn/Infant

Additional relevant MeSH terms:
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Neonatal Abstinence Syndrome
Infant, Newborn, Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders