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Interventions to Help Infants Recover in the Hospital

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ClinicalTrials.gov Identifier: NCT03881553
Recruitment Status : Terminated (Covid halt in March; PI subsequently moved to another Institution)
First Posted : March 19, 2019
Last Update Posted : December 14, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Elisabeth Salisbury, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE March 3, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date December 14, 2020
Actual Study Start Date  ICMJE July 19, 2019
Actual Primary Completion Date March 7, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interventions to Help Infants Recover in the Hospital
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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  ICMJE
  • Infant Apnea
  • Neonatal Abstinence Syndrome
  • Sleep
Intervention  ICMJE
  • 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 10, 2020)
14
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2019)
15
Actual Study Completion Date  ICMJE March 7, 2020
Actual Primary Completion Date March 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Weeks to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03881553
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Elisabeth Salisbury, University of Massachusetts, Worcester
Study Sponsor  ICMJE Elisabeth Salisbury
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Elisabeth Salisbury, PhD UMass Medical School
PRS Account University of Massachusetts, Worcester
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP