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Interventions to Help Infants Recover in the Hospital

Primary Purpose

Infant Apnea, Neonatal Abstinence Syndrome, Sleep

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NEATCAP
SVS mattress
Sponsored by
Elisabeth Salisbury, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Infant Apnea focused on measuring Prematurity, Neonatal Abstinence Syndrome, Autonomic Function, Sleep, Stochastic Resonance, Newborn/Infant

Eligibility Criteria

2 Days - 3 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UMass Medical School

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Premature Infants (NICU)

Opioid-Exposed Newborns (NICU)

Hospitalized Infants (PICU)

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Sleep Rate With and Without NEATCAP Intervention
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.
Mean Respiratory Rate With and Without Intervention
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.
Mean Heart Rate With and Without Intervention
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.

Secondary Outcome Measures

Mean Movement Activity
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.

Full Information

First Posted
March 3, 2019
Last Updated
May 27, 2022
Sponsor
Elisabeth Salisbury, PhD
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03881553
Brief Title
Interventions to Help Infants Recover in the Hospital
Official Title
Interventions to Help Infants and Children Recover in the Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Covid halt in March; PI moved to another Institution
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elisabeth Salisbury, PhD
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Apnea, Neonatal Abstinence Syndrome, Sleep
Keywords
Prematurity, Neonatal Abstinence Syndrome, Autonomic Function, Sleep, Stochastic Resonance, Newborn/Infant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premature Infants (NICU)
Arm Type
Experimental
Arm Description
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.
Arm Title
Opioid-Exposed Newborns (NICU)
Arm Type
Experimental
Arm Description
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.
Arm Title
Hospitalized Infants (PICU)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NEATCAP
Other Intervention Name(s)
NEATCAP DREAMIES (NEATCap Medical, LLC)
Intervention Description
NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.
Intervention Type
Device
Intervention Name(s)
SVS mattress
Intervention Description
SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation.
Primary Outcome Measure Information:
Title
Sleep Rate With and Without NEATCAP Intervention
Description
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.
Time Frame
Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Title
Mean Respiratory Rate With and Without Intervention
Description
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.
Time Frame
Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Title
Mean Heart Rate With and Without Intervention
Description
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.
Time Frame
Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Secondary Outcome Measure Information:
Title
Mean Movement Activity
Description
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.
Time Frame
Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elisabeth Salisbury, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28426726
Citation
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.
Results Reference
background
PubMed Identifier
19608934
Citation
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.
Results Reference
background
PubMed Identifier
33857731
Citation
Balsan MJ, Burns J, Kimock F, Hirsch E, Unger A, Telesco R, Bloch-Salisbury E. A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates. Early Hum Dev. 2021 May;156:105365. doi: 10.1016/j.earlhumdev.2021.105365. Epub 2021 Mar 26.
Results Reference
background
PubMed Identifier
35460141
Citation
Bloch-Salisbury E, McKenna L, Boland E, Chin D. Assessment of a hearing protection device on infant sleep in the neonatal intensive care unit. J Sleep Res. 2023 Apr;32(2):e13610. doi: 10.1111/jsr.13610. Epub 2022 Apr 22.
Results Reference
result
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT02744066?term=neatcap&rank=1
Description
A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device (NEATCAP)
URL
https://clinicaltrials.gov/ct2/show/NCT02801331?term=Salisbury&cond=NAS&rank=2
Description
Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome

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Interventions to Help Infants Recover in the Hospital

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