Interventions to Help Infants Recover in the Hospital

May 27, 2022 updated by: Elisabeth Salisbury, PhD

Interventions to Help Infants and Children Recover in the Hospital

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Rate With and Without NEATCAP Intervention
Time Frame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Within each Group, percent sleep (and inversely percent wake) duration will be compared for periods of device on and device off separately for each intervention device within each study session.
Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Mean Respiratory Rate With and Without Intervention
Time Frame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Within each Group, mean respiratory rate will be compared for periods of device on and device off separately for each intervention device within each study session.
Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Mean Heart Rate With and Without Intervention
Time Frame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Within each Group, mean heart rate will be compared for periods of device on and device off separately for each intervention device within each study session.
Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Movement Activity
Time Frame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Within each Group, mean movement activity will be compared for periods of device on and device off separately for each intervention device within each study session.
Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elisabeth Salisbury, PhD

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Elisabeth Salisbury, PhD, University of Massachusetts, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2019

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

March 3, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H00015487
  • U54HL143541 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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