Interventions to Help Infants Recover in the Hospital

Study Overview
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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.

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.

Official Title
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Interventions to Help Infants and Children Recover in the Hospital

Conditions
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Infant Apnea, Neonatal Abstinence Syndrome, Sleep

Intervention / Treatment
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* Device: NEATCAP
* Device: SVS mattress


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Days
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Premature Infants (NICU)<br>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<br>* NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.<br>* Other names: NEATCAP DREAMIES (NEATCap Medical, LLC);Device: SVS mattress<br>* SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation.<br>|
| Experimental: Opioid-Exposed Newborns (NICU)<br>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<br>* NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.<br>* Other names: NEATCAP DREAMIES (NEATCap Medical, LLC);Device: SVS mattress<br>* SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation.<br>|
| Experimental: Hospitalized Infants (PICU)<br>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<br>* NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.<br>* Other names: NEATCAP DREAMIES (NEATCap Medical, LLC);Device: SVS mattress<br>* SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF) | 
| 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. | Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF) | 
| 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. | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prematurity, Neonatal Abstinence Syndrome, Autonomic Function, Sleep, Stochastic Resonance, Newborn/Infant