News & Events - The Buzz on DREAMIES
More Effort Needed to Protect Neonatal Intensive Care Patients from Noise
June 2022
Neonatal Intensive Care published an interview with Andrew Unger, MD, FAAP, Medical Advisor to NEATCap Medical LLC. Dr Unger explained why noise protection is important for neonatal intensive care patients to encourage sleep and reduce stress. Dr Unger identified some particular neonatal care situations where effective noise protection may be particularly important during routine ICU care, during emergency transport and MRI. See: A Unger. More Effort Needed to Protect Neonatal Intensive Care Patients from Noise. Neonatal Intensive Care, 35, 3 (2022) 37-38.
Study Published in Journal of Sleep Research Finds DREAMIES Promotes Sleep
April 2022
Results of a clinical study with “gold standard” sleep analysis by polysomnography with EEG published in the Journal of Sleep Research demonstrated premature infants experienced 14% more sleep and increased active sleep when wearing DREAMIES. Findings suggest that DREAMIES may augment sleep in premature infants by reducing acute episodes of adverse noise in the NICU. See: E. Bloch-Salisbury, et al. Assessment of a hearing protection device on infant sleep. J Sleep Research (2022) 1-5.
Results of Sleep Study with DREAMIES presented at PAS 2022
April 2022
Dr Elisabeth Bloch-Salisbury presented clinical research findings of increased sleep when infants wore DREAMIES. Detailed polysomnography results on 10 preemies supported earlier findings of Balsan et al (2021) who found increased sleep in NICU patients using behavioral state observations. See: E. Bloch-Salisbury, et al. A Novel Hearing Protection Device to Promote Sleep in Hospitalized Neonates. Pediatric Academic Society Meeting PAS 2022, Denver, CO. Apr 21-25, 2022.
NICU Noise: We’re Finally Getting Somewhere!
January 2022
Andrew Unger, MD, FAAP, published a review of the history of NICU noise guidelines and clinical significance of noise exposure for NICU patients in Neonatal Intensive Care. Dr Unger concluded that an ear muff device designed specifically for NICU patients and their varied acoustic environments would be a key part of a data-driven, holistic approach to reducing stressful infant noise exposure and improving patient care. See: A Unger. NICU Noise: 50 Years of Worry, and We’re Finally Getting Somewhere! Neonatal Intensive Care, 35 (2022) 24-26.
DREAMIES US Patent 11,185,447 Issued
November 2021
US Patent 11,185,447 is issued by the USPTO. The patented medical headgear device incorporates a flexible headband with areas of controlled stretching and pads to gently grip the skin and stabilize the headband position.
NEATCap Medical Joins CTIP Pediatrics Device Consortium
May 2021
NEATCap Medical is accepted into the company portfolio of The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP), an FDA-funded pediatric medical device accelerator centered at Children's Hospital Los Angeles and the University of Southern California.
DREAMIES NICU Study Published in Early Human Development
April 2021
Findings of a clinical study reported in the premiere journal Early Human Development suggest DREAMIES are a safe, easy to use, and effective device that reduces exposure to NICU noise, and may improve physiological activity and promote sleep among neonatal patients.
DREAMIES T-M MRI Safety Testing Completed
November 2020
MRI testing at a premiere test laboratory demonstrated that the NEATCAP DREAMIES T-M device is MR Safe.
Winnie Palmer Hospital begins DREAMIES T-M Transport Study
October 2020
Winnie Palmer Hospital for Women and Babies initiates a 50-patient study using DREAMIES T-M in their “Mobile ICU” emergency transport ground ambulance and their helicopter air transport ambulance. Prior to the study, NEATCap used it’s DONNE sound measuring technology to characterize the noise sounds and demonstrate DREAMIES T-M noise blocking capability within Winnie Palmer’s transport incubators.
NEATCAP and DREAMIES Trademarks Registered
July 2020
USPTO issues NEATCAP Trademark Reg. No. 6,111,045 and DREAMIES Trademark Reg. No. 6,111,045, covering NEATCap Medical’s headband and hearing protectors.
Preemie Sleep Study Data Collected at UMass
March 2020
Researcher Dr Elisabeth Bloch-Salisbury completed data collection in a full-polysomnography study with 10 premature infants at the University of Massachusetts Memorial Hospital NICU. The study is evaluating the effect of wearing DREAMIES for improving sleep and cardio-respiratory function in premature infants (clinical trial NCT03881553). Data analysis is currently underway.
Neonatal & Pediatric Transport Sound Study Completed
October 2019
NEATCap completes an 8-month study of the unique sound environment of neonatal and pediatric emergency transport. Sound recordings of approximately 40 transport runs (via ground and helicopter ambulance) both inside transport incubators, and on pediatric stretchers were made with NEATCap’s DONNE sound measuring device, with support from UPMC Children’s Hospital of Pittsburgh emergency transport team. Measurements demonstrated the sound blocking capability of DREAMIES T-M in actual neonatal and pediatric transport environments.
DREAMIES US Patent 10,413,696 Issued
September 2019
US Patent 10,413,696 is issued by the USPTO. The patented medical headgear device incorporates a semi-elastic stabilizing band, noise-reducing ear cups, and other features to improve NICU patient care.
Transport Noise Measured at Winnie Palmer
March 2019
In collaboration with emergency transport team at Winnie Palmer Hospital (WPH) for Women and Babies, NEATCap completes measurements of the sound environment within WPH transport incubators, during ground ambulance, helicopter ambulance, and intra-hospital transport. Results obtained with NEATCap’s DONNE sound measuring device demonstrated the sound blocking capability of DREAMIES T-M directly in these 3 transport environments.
NEATCap Medical, LLC Awarded KIZ Tech Transfer Grant
December 2018
NEATCap, LLC receives $15k Southside Bethlehem Keystone Innovation Zone Technology Transfer Grant to be used to upgrade NEATCap Medical’s quality and manufacturing systems, and branding to support commercial sales launch.
DREAMIES NICU Study Presented at 2018 Gravens Conference
February 2018
Mike Balsan, MD, Medical Director of NICU, Magee Womens Hospital, UPMC Hamot presented the successful DREAMIES NICU pilot study results in a poster “Evaluation of a Novel Hearing Protection Device in the NICU” at the 31st Annual Gravens Conference on the Environment of Care for High Risk Newborns in Clearwater, FL. Gayle Thear and Ed Thear of NEATCap Medical supported Dr Balsan with DREAMIES on display.
NEATCap NICU Clinical Study Successfully Completed
October 2017
NICU Clinical Study Part 2 with NEATCap's device is successfully completed at Magee-Womens Hospital, UPMC Hamot, with devices placed on 25 NICU babies for one 8-hour shift for 3 consecutive days. Assessments of nursing ease-of-use, patient tolerance and vital signs are again positive, and infant behavioral state assessments suggest increased periods of sleep between feeds.
NEATCap Survey and Introduction Launched
August 2017
In collaboration with Univ of North Carolina Wilmington (UNCW), NEATCap Medical launches national survey to hospital NICU professionals.
NEATCap NICU Clinical Study Part 1 Completed
May 2017
Part 1 of the first Clinical Study with NEATCap's device is successfully completed at Magee-Womens Hospital, UPMC Hamot NICU in Erie, PA. Devices were placed on 25 NICU babies for 1 hour. Positive assessments of nursing ease-of-use, patient tolerance and vital signs were found.
NEATCap Medical Manufactures Devices for Clinical Study
January 2017
Neatcap Medical manufactures product in its Bethlehem, PA facility under GMP, and delivers devices to Magee-Womens Hospital, UPMC Hamot for Part 1 of the pilot clinical study.
The NEATCap Story Presented at DaVinci Science Center
September 2016
Fred Kimock of NEATCap Medical presents "The NEATCap Story" about the development history of NEATCap's product at Allentown's DaVinci Science Center. The story explains how a problem-focused and user-focused development leads to an unexpected, innovative, easy-to-use product.
NEATCap Presented to Wilmington Network for Entrepreneurs
May 2016
Ed Thear of NEATCap Medical presents at Network for Entrepreneurs – Wilmington (NC), discussing the challenges of caring for premature infants in the Neonatal Intensive Care Unit environment. Ed discussed NEATCap's elegant solution to reducing premature infant noise exposure by providing a device with sound blocking performance that resembles the natural noise protection provided by a mother’s body during pregnancy.
NEATCap Medical Receives Funding for Pilot Clinical Study
May 2016
As part of the Pitt Innovation Challenge (PInCh®) award from the University of Pittsburgh's Clinical & Translational Science Institute, NEATCap Medical, LLC receives funding from the University of Pittsburgh for Investigational Devices for pilot study at Magee-Womens Hospital, UPMC Hamot.
NEATCap Medical, LLC is Formed
December 2015
NEATCap Medical, LLC is formed as a subsidiary spin-off of NEATCap, LLC to complete product development and manufacturing process development of NEATCap’s device. NEATCap Medical begins development of its manufacturing facility and equipment in Bethlehem, PA.
NEATCAP Team Wins Pitt Innovation Challenge
November 2015
NEATCAP project team is named a $100k award winner of the Fall 2015 University of Pittsburgh Innovation Challenge (PInCh®), for a project to perform a pilot clinical study on NEATCap’s device. The project team is comprised of Magee-Womens Hospital, UPMC Hamot NICU neonatology and NICU nursing staff with device consulting support from NEATCap, LLC.