# A Novel Non-Invasive Method of Dysphagia Detection in Preterm Infants: Bottle Finalization & Validation

> **NIH NIH R42** · NUBORN MEDICAL, INC. · 2024 · $859,275

## Abstract

PROJECT SUMMARY/ABSTRACT
Ten percent of the approximately four million infants born in the United States each year are
born premature (<37 weeks gestational age). Preterm birth prior to the maturation of critical
neonatal body systems results in prolonged hospitalizations that impose an annual societal cost
burden of $26 billion. Achievement of the ability to fully orally feed is often the last
developmental milestone these infants achieve, with the time it takes for patients to meet this
milestone accounting for as much as 90% of the variance of their total length of hospital stay. In
addition to prolonging neonatal hospital stays these swallowing deficits (dysphagia) pose
detrimental health effects including pulmonary aspiration, cardiopulmonary instability, and
malnutrition. Early diagnostics and treatment are critical to maximizing neonatal health
outcomes and reducing hospital expenditures. While the gold standard videofluoroscopic
swallow study is an effective diagnostic method, its emission of harmful radiation limits its
regular clinical utilization. The available alternative assessment, clinical observation, is
subjective with inherent limitations in its validity of detecting underlying deficits. nuBorn
Medical has developed a SMART bottle that allows for the non-invasive objective assessment of
an infant's oropharyngeal sucking and swallowing abilities. With this tool clinicians can identify
swallowing deficits and determine the appropriate treatment regimens to enable earlier and
more accurate methods of dysphagia management than in the current standard of care. In this
Phase II STTR investigation, nuBorn Medical's SMART bottle will undergo its final stages of
product refinement to maximize user experience, and and gather critical information necessary
to substantiate claims in its upcoming FDA application.

## Key facts

- **NIH application ID:** 11008443
- **Project number:** 2R42HD104305-02
- **Recipient organization:** NUBORN MEDICAL, INC.
- **Principal Investigator:** Katlyn Elizabeth McGrattan
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $859,275
- **Award type:** 2
- **Project period:** 2020-09-16 → 2027-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11008443

## Citation

> US National Institutes of Health, RePORTER application 11008443, A Novel Non-Invasive Method of Dysphagia Detection in Preterm Infants: Bottle Finalization & Validation (2R42HD104305-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11008443. Licensed CC0.

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