Clinical trial NCT03881553: Interventions to Help Infants Recover in the Hospital
Official title: Interventions to Help Infants and Children Recover in the Hospital
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infant Apnea
Neonatal Abstinence Syndrome
Sleep
Keywords: Prematurity
Neonatal Abstinence Syndrome
Autonomic Function
Sleep
Stochastic Resonance
Newborn/Infant
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-03-19
Enrollment: 17
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Within-subjects design. Each subject will serve as own control and receive periods of intervention and no intervention within a study session.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep Rate With and Without NEATCAP Intervention
timeFrame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
measure: Mean Respiratory Rate With and Without Intervention
timeFrame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
measure: Mean Heart Rate With and Without Intervention
timeFrame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Secondary outcomes:
measure: Mean Movement Activity
timeFrame: Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Elisabeth Salisbury, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.