Interventions to Help Infants Recover in the Hospital

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-19

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infant Apnea Neonatal Abstinence Syndrome Sleep

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Within-subjects design. Each subject will serve as own control and receive periods of intervention and no intervention within a study session.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NEATCAP

Intervention Type DEVICE

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

SVS mattress

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

NEATCAP

Intervention Type DEVICE

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

SVS mattress

Intervention Type DEVICE

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

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.

Group Type EXPERIMENTAL

NEATCAP

Intervention Type DEVICE

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

SVS mattress

Intervention Type DEVICE

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

Interventions

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NEATCAP

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

Intervention Type DEVICE

SVS mattress

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

Intervention Type DEVICE

Other Intervention Names

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NEATCAP DREAMIES (NEATCap Medical, LLC)

Eligibility Criteria

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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.

Minimum Eligible Age

2 Days

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No