PremieBreathe

PremieBreathe is a breathing aid to help premature newborns in resource-constrained settings.

Discontinued

Snapshot
Manufacturing & delivery
Performance & use
Research & standards
Feedback

Product description Brand name and product description

PremieBreathe is a low-cost breathing aid for newborn babies that provides humidified air flow to neonates and was developed by a start-up formed by a multi-departmental collaboration at Yale University. The product is designed for settings that lack safe respiratory devices and is intended to address neonatal mortality due to respiratory complications. In 2016 PremieBreathe was under trial. We have no further updated information as of 2021.

Target region(s) Target region for distribution/implementation (listed by country if specified)

Ethiopia, Malawi, Rwanda

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

Unknown

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

350 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Pumani Bubble Continuous Positive Airway Pressure (bCPAP) Device, Neovent, FREO2Siphon

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Neonatal healthcare personnel: doctors and nurses

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

This product is currently in the prototyping phase and not yet manufactured at scale. Prototypes are being developed at Yale University in Prof. Gonzalez’s lab.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Patented

User Provision Model Where can the product be purchased/acquired by end users?

The designers have not yet selected their user provision model.

Distribution to date Number of units that have been deployed, downloads or users to date

None – product still in prototype stage

Fields marked are sourced values that have been evaluated by the manufacturer or a third party, all others are design specifications.

Consumables

List or none.

Oxygen and Sterile Water

Power supply type

Continuous, Recharging only, None, Other

Indispensable equipment for function

Oxygen Generators

Maintenance or calibration required by user at time of use? (Y/N)

Yes

Display Type

Flowmeter

Gas Flow Range (L/min)

Pressure Range (cm H2O)

Unknown

Patient population (specify)

Neonates

Design specifications Component and Operation overview including power, portability, facility requirements, preventative maintenance and user training requirements

PremieBreathe, is a humidified high flow nasal cannula (HHFNC) device that delivers variable flows of warmed, humidified, and oxygenated air to provide respiratory support for premature and newborn infants. The device incorporates an ultraviolet water sterilization mechanism to kill waterborne bacteria. It also incorporates reusable, biofouling-resistant tubing rather than the disposable circuit used in the commercial technology, embodied by a mobile, compact housing, designed to incorporate a rechargeable battery source, ensures that our device can provide portable oxygen therapy for critically ill newborns in need of undisrupted support, while in transport between hospitals and health centers.

Product schematics Design and assembly illustrations

Not available

Technical support Technical support provided by

Provided by the manufacturers

Replacement components Availability of replacement components (in-country, by order,...)

Replacement components include flow regulators and humidification bottles.

Lifecycle Disposal and warranty

Unknown

Manufacturer specified performance targets Designer / Manufacturer specified targets

The maufacturers set out to develop a low-cost respirator that can safely provide warmed, humidified and blended oxygen to neonates in need.

Vetted performance Findings of manufacturer evaluations or independent testing centers

Pilot tests were performed in Ethiopia at Ayder Referral Hospital to establish the performance and functional parameters after about a half-a-dozen prototyping iterations.

Testing organizations Independent lab, academic research centers, etc.

Yale Institute for Global Health, Yale University, Ayder Referral Hospital, and PremieBreathe.

Safety Potential hazards / risks related to operation of this product

The manufacturers have taken steps to test the device in a clinical environment to ensure its safety.

Complementary technical systems Performance of this product is improved with another technology (eg. Cookstoves and Wind-blocking skirts)

Unknown

Academic research Academic research related to the product (e.g. published papers in peer-reviewed journals)

Wang, D., 2016, “PremieBreathe: A Low-Cost Respiratory Aid for the Developing World.”

Matthews, M., et al., 2017, “PREferred Providers,” ASEE Prism, 27(2), pp. 24-31.

2018, “Third WHO global forum on medical devices: international conference center Geneva: Geneva, Switzerland 10–12 May 2017,” No. WHO/EMP/2018.02,World Health Organization.

Compliance with regulations Product certifications and standards referenced by designer/manufacturer

None

Evaluation methods Evaluation methods/protocols/guidelines referenced by designer or manufacturer.

Unknown

Other information

None

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In context files & documents (0)

Feedback from users, customers & distributors

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Snapshot

Product description Brand name and product description

Target region(s) Target region for distribution/implementation (listed by country if specified)

Ethiopia, Malawi, Rwanda

Distributors/implementing organizations Organization(s) distributing/deploying this product directly to communities/individuals?"

Unknown

Market suggested retail price Price per unit or service price per usage/terms (USD). Subsidies noted.

350 USD

Competitive landscape Similar products available on the market. May not be a comprehensive listing.

Pumani Bubble Continuous Positive Airway Pressure (bCPAP) Device, Neovent, FREO2Siphon

SDG targeted United Nations Sustainable Development Goals (SDGs) targeted with this product/application/service

Goal 3: Good health and well-being

Target user(s) Target user/consumer base (country, income segment)

Neonatal healthcare personnel: doctors and nurses

Manufacturing & delivery

Manufacturing/building method(s) Detail regarding solution production or construction method (instructions, mass production capacity, custom made,etc...)

This product is currently in the prototyping phase and not yet manufactured at scale. Prototypes are being developed at Yale University in Prof. Gonzalez’s lab.

Product Intellectual Property Open source/IP protected (note patent)/trade secret/other?

Patented

User Provision Model Where can the product be purchased/acquired by end users?

The designers have not yet selected their user provision model.

Distribution to date Number of units that have been deployed, downloads or users to date

None – product still in prototype stage

Performance & use