Interventions to Help Infants Recover in the Hospital

Sleep Clinical Trial

Official title:

Interventions to Help Infants and Children Recover in the Hospital

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03881553
• Other study ID #: H00015487
• Secondary ID: U54HL143541
• Status: Terminated
• Phase: N/A
• Start date: July 19, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2022
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infant Apnea
• Neonatal Abstinence Syndrome
• Sleep

Intervention

Device:
• NEATCAP
NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.
• SVS mattress
SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation.

Locations

Country	Name	City	State
United States	UMass Medical School	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Elisabeth Salisbury, PhD	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. 2022 Apr 22. doi: 10.1111/jsr.13610. [Epub ahead of print] — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)
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.	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.	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.	Between 8 to 12 hours (reflecting 3 interfeed periods NEATCAP OFF then ON then OFF)

External 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