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| ID | Type | Description | Link |
|---|---|---|---|
| U54HL143541 | U.S. NIH Grant/Contract | View source |
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Covid halt in March; PI moved to another Institution
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Premature Infants (NICU) | Experimental | 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 (NICU) | Experimental | 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. |
|
| Hospitalized Infants (PICU) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEATCAP | Device | NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise. |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Salisbury, PhD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Medical School | Worcester | Massachusetts | 01655 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28426726 | Background | 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. | |
| 19608934 | Background | 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. |
| Label | URL |
|---|---|
| A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device (NEATCAP) | View source |
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Within-subject design so each participant received periods with and without the intervention (NEATCAP and SVS mattress device). Assignment was based on equipment availability. Number of study sessions may have been related to: discharged from hospital prior to opportunity to participate in 1 or more study sessions; i.e., personnel and/or equipment availability to schedule session; Covid-19 halt on in-person subject participation; termination of project.
Recruitment in the neonatal and pediatric hospital units where infants receiving in-patient care.
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| ID | Title | Description |
|---|---|---|
| FG000 | Premature Infants (NICU) | Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP. |
| FG001 | Opioid-Exposed Newborns (NICU) | Opioid-exposed newborns receiving care in the Neonatal Intensive Care Unit (NICU) participated in 1 session with NEATCAP. |
| FG002 | Hospitalized Infants (PICU) | Infants receiving treatment in the Pediatric Intensive Care or Inpatient Unit participated in up to 2 sessions with SVS mattress intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Reported only on Arm 1 infants who participated in the study session. Did not report on participants in Arm 2 or Arm 3 due to small number of participants risk of potential identification.
Data not collected on enrolled (consented) who did not participate in the study intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Experimental: Opioid-Exposed Newborns (NICU) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percent of period sleep | Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF) |
|
up to 24 hours following completion of a study session
Potential risk of adverse events described in IRB study plan and consent form include: skin irritation and or rash due to NEATCAP device and/or additional sensors used to record physiological signals that does not resolve by end of study session. Subsequent report by bedside medical caregiver of exacerbated function post study session not apparently related to infant current problems.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Premature Infants (NICU): NEATCAP Device | Premature infants receiving care in the Neonatal Intensive Care Unit (NICU) will participated in 1 session with NEATCAP intervention |
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Early termination leading to incomplete arms of trial. Accordingly, due to small n from the early termination of the trial, outcomes in Arm 2 and Arm 3 are not reported due to potential risk of participant identification.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elisabeth Salisbury, PhD | University of Pittsburgh School of Medicnie | 412-246-5378 | salisburye2@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2020 | May 27, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009357 | Neonatal Abstinence Syndrome |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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Within-subjects design. Each subject will serve as own control and receive periods of intervention and no intervention within a study session.
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|
| SVS mattress | Device | SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation. |
|
| 33857731 | Background | 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. |
| 35460141 | Result | 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. |
| Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome | View source |
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. |
| BG002 | 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 to 2 sessions with SVS mattress intervention. |
| BG003 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection). | Mean | Standard Deviation | weeks |
|
| Sex: Female, Male | Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection). | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection). | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection). | Count of Participants | Participants |
|
| Mean Post-Menstrual Age at time of 1st session | Count of participants includes only those subjects who participated in the study intervention. Data was not collected on enrolled (consented) subjects who did not participate in study intervention (i.e., discharged or withdrawn prior to any data collection). | Mean | Standard Deviation | weeks |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | breaths/min | Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF) |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | beats/min | Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | percent | Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Opioid-Exposed Newborns (NICU): NEATCAP Device | Opioid-exposed newborns receiving care in the Neonatal Intensive Care Unit (NICU) participate in 1 session with NEATCAP intervention. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Hospitalized Infants (PICU): Mattress Device | Infants receiving treatment in the Pediatric Intensive Care participate in up to 2 sessions with SVS mattress intervention. | 0 | 3 | 0 | 3 | 0 | 3 |
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| D001523 | Mental Disorders |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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