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Infant ApneaNCT03881553

Interventions to Help Infants Recover in the Hospital

A study testing NEATCAP and SVS mattress in people with Infant Apnea and Neonatal Abstinence Syndrome, run by Elisabeth Salisbury, PhD at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 2 days to 3 years
Conditions the study is for
Infant Apnea, Neonatal Abstinence Syndrome, Sleep
What is being tested?
NEATCAP and SVS mattress
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteUnited States
Study dates
19 Jul 2019to 31 Dec 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 days to 3 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UMass Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
NEATCAP, SVS mattress
Keywords
Prematurity, Neonatal Abstinence Syndrome, Autonomic Function, Sleep, Stochastic Resonance, Newborn/Infant
Medical subject headings
Neonatal Abstinence Syndrome, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NEATCAPDevice

    Also called NEATCAP DREAMIES (NEATCap Medical, LLC)

    NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.

  • SVS mattressDevice

    SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation.

Study groups in NCT03881553
Study groupRoleWhat they receive
Premature Infants (NICU)ExperimentalPremature 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.
Receives: Device: NEATCAP; Device: SVS mattress
Opioid-Exposed Newborns (NICU)ExperimentalOpioid-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.
Receives: Device: NEATCAP; Device: SVS mattress
Hospitalized Infants (PICU)ExperimentalInfants 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.
Receives: Device: NEATCAP; Device: SVS mattress

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)

  2. 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.

    Measured: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)

  3. 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.

    Measured: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)

Secondary outcomes (1)

  1. 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.

    Measured: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2019
  2. Study start19 Jul 2019
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Why it stopped: Covid halt in March; PI moved to another Institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03881553
Sponsor's protocol ID
H00015487
Other IDs
U54HL143541
Status last verified
May 2022
First submitted
3 Mar 2019
Last updated
1 Jun 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 28426726

  • 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.

    PubMed 19608934

  • 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.

    PubMed 33857731

  • 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.

    PubMed 35460141

Questions about this trial

What is this clinical trial studying?

A study testing NEATCAP and SVS mattress in people with Infant Apnea and Neonatal Abstinence Syndrome, run by Elisabeth Salisbury, PhD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep Rate With and Without NEATCAP Intervention (time frame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03881553, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.

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