Interventions to Help Infants Recover in the Hospital

NCT03881553 | Terminated Results FDA Device

• 2 other identifiers: H00015487U54HL143541
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant Apnea; Neonatal Abstinence Syndrome; Sleep

Keywords

Prematurity; Neonatal Abstinence Syndrome; Autonomic Function; Sleep; Stochastic Resonance; Newborn/Infant

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Mean Movement Activity

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

Study Arms (3)

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.

Device: NEATCAP; Device: SVS mattress

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.

Device: NEATCAP; Device: SVS mattress

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.

Device: NEATCAP; Device: SVS mattress

Interventions

NEATCAP DEVICE

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

Also known as: NEATCAP DREAMIES (NEATCap Medical, LLC)

Hospitalized Infants (PICU); Opioid-Exposed Newborns (NICU); Premature Infants (NICU)

SVS mattress DEVICE

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

Hospitalized Infants (PICU); Opioid-Exposed Newborns (NICU); Premature Infants (NICU)

Eligibility Criteria

• Age: 2 Days - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elisabeth Salisbury, PhD: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01655, United States

Location

Related Publications (4)

• 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.

  PMID: 28426726 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.

  PMID: 19608934 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.

  PMID: 33857731 BACKGROUND

• 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.

  PMID: 35460141 RESULT

Related Links

• A Pilot Study to Evaluate Patient Tolerance and Nursing Ease-of-Use of a Novel Hearing Protection Device (NEATCAP)
• Efficacy and Outcomes of a Non-Pharmacological Intervention for Neonatal Abstinence Syndrome

MeSH Terms

Conditions

Neonatal Abstinence Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Elisabeth Salisbury, PhD
• Organization: University of Pittsburgh School of Medicnie

salisburye2@upmc.edu

412-246-5378

Study Officials

• Elisabeth Salisbury, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Associate Professor

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

Study Record Dates

• First Submitted: March 3, 2019
• First Posted: March 19, 2019
• Study Start: July 19, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 1, 2022
• Results First Posted: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)