Dataset Information

A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates.

ABSTRACT:

Background

Loud noises in the neonatal intensive care unit (NICU) exacerbate patient cardiac and respiratory activity, disrupt sleep, and may contribute to hearing deficits, speech and language disorders, and neurodevelopmental delays among NICU graduates.

Aims

This study evaluated infant-patient tolerance and nurse ease of use of a novel frequency-selective hearing protection device, DREAMIES (NEATCap Medical, LLC).

Study design and subjects

Fifty neonates receiving care in a Level III NICU participated in a 2-phase prospective study. In Phase 1, 25 infants (mean 36.6 wks GA) wore DREAMIES for two consecutive 30-min periods. In Phase 2, 25 infants (mean 34.8 wks GA) wore DREAMIES between care and feeding times during an 8-h Device-On period followed by an 8-h Device-Off period for three consecutive days.

Outcome measures

Subject tolerance was defined by device-related skin irritation, vital sign measurements, and behavioral state. Device fit and ease of use were also evaluated by NICU nurses.

Results

No skin breakdown was reported in any infant in either phase. Only transient skin erythema was observed. Periods when infants wore DREAMIES resulted in lower heart and respiratory rates and increased sleep (P < 0.001). Nurses reported little to no difficulty in applying or removing the device.

Conclusion

Findings suggest DREAMIES are a safe, easy to use, and effective device that reduces exposure to NICU noise, and may improve cardio-respiratory activity and promote sleep among neonatal patients. Further studies are warranted to examine longer term use and potential benefits of DREAMIES for improving outcomes in infants receiving NICU care. This trial is registered on clinicaltrials.govNCT02744066.

SUBMITTER: Balsan MJ

PROVIDER: S-EPMC8771502 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Publications

A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates.

Balsan Michael J MJ Burns Jeanne J Kimock Fred F Hirsch Emily E Unger Andrew A Telesco Richard R Bloch-Salisbury Elisabeth E

Early human development 20210326

<h4>Background</h4>Loud noises in the neonatal intensive care unit (NICU) exacerbate patient cardiac and respiratory activity, disrupt sleep, and may contribute to hearing deficits, speech and language disorders, and neurodevelopmental delays among NICU graduates.<h4>Aims</h4>This study evaluated infant-patient tolerance and nurse ease of use of a novel frequency-selective hearing protection device, DREAMIES (NEATCap Medical, LLC).<h4>Study design and subjects</h4>Fifty neonates receiving care i ...[more]

PMID: 33857731

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Project description:ObjectiveAcute kidney injury (AKI) is a highly morbid condition in critically ill patients that is associated with high mortality. Previous clinical studies have demonstrated the safety and efficacy of the Selective Cytopheretic Device (SCD) in the treatment of AKI requiring continuous renal replacement therapy in the intensive care unit (ICU).Design, setting, patientsA randomized, controlled trial of 134 ICU patients with AKI, 69 received continuous renal replacement therapy (CRRT) alone and 65 received SCD therapy.ResultsNo significant difference in 60-day mortality was observed between the treated (27/69; 39%) and control patients (21/59; 36%, with six patients lost to follow up) in the intention to treat (ITT) analysis. Of the 19 SCD subjects (CRRT+SCD) and 31 control subjects (CRRT alone) who maintained a post-filter ionized calcium (iCa) level in the protocol's recommended range (≤ 0.4 mmol/L) for greater or equal to 90% of the therapy time, 60-day mortality was 16% (3/19) in the SCD group compared to 41% (11/27) in the CRRT alone group (p = 0.11). Dialysis dependency showed a borderline statistically significant difference between the SCD treated versus control CRRT alone patients maintained for ≥ 90% of the treatment in the protocol's recommended (r) iCa target range of ≤ 0.4 mmol/L with values of, 0% (0/16) and 25% (4/16), respectively (P = 0.10). When the riCa treated and control subgroups were compared for a composite index of 60 day mortality and dialysis dependency, the percentage of SCD treated subjects was 16% versus 58% in the control subjects (p<0.01). The incidence of serious adverse events did not differ between the treated (45/69; 65%) and control groups (40/65; 63%; p = 0·86).ConclusionSCD therapy may improve mortality and reduce dialysis dependency in a tightly controlled regional hypocalcaemic environment in the perfusion circuit.Trial registrationClinicalTrials.gov NCT01400893 http://clinicaltrials.gov/ct2/show/NCT01400893.

Dataset Information

A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates.

Background

Aims

Study design and subjects

Outcome measures

Results

Conclusion

Publications

A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates.

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