Trial reportEarly human development2021
A pilot study to assess the safety, efficacy and ease of use of a novel hearing protection device for hospitalized neonates.
Trial report in Early human development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03881553 (Interventions to Help Infants and Children Recover in the Hospital), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Interventions to Help Infants and Children Recover in the Hospital
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.
- Noise or sound management in the neonatal intensive care unit for preterm or very low birth weight infants.The Cochrane database of systematic reviews · 2024Pooled it
- Physiologic dysregulation in newborns with prenatal opioid exposure: Cardiac, respiratory and movement activity.Neurotoxicology and teratologyTrial
- Noise prevention strategies among neonatal intensive care unit nurses: a qualitative study.BMC nursing · 2025Article
- Assessment of a hearing protection device on infant sleep in the neonatal intensive care unit.Journal of sleep research · 2023Article
- Prevention of Noise-Induced Hearing Loss Using Investigational Medicines for the Inner Ear: Previous Trial Outcomes Should Inform Future Trial Design.Antioxidants & redox signaling · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundLoud 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.
aimsThis 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.
resultsNo 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.
conclusionFindings 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.