OLATHE, Kan., Feb. 28, 2019 (GLOBE NEWSWIRE) -- Innara Health, Inc, (the “Company"), a commercial stage medical technology business delivering feeding health innovation, today announced new research featuring the Company’s NTrainer System®. The efficacy and safety data confirm that the device’s “pulsing” pacifier therapy improves feeding development in premature infants and reduces their length of neonatal intensive care unit (NICU) hospitalization stay.
The multicenter randomized controlled trial enrolled a total of two-hundred and ten (210) NICU preterm infant patients across five US NICU locations at Santa Clara Valley Medical Center, two sites in the Montefiore-Albert Einstein College of Medicine system, Baptist Health, and the Cook Children's Health Care system. The study, “Patterned Oral Stimulation in Preterm Infants,” was conducted by Dr. Dongli Song, et al., to evaluate the effects of the NTrainers’ oral motor intervention on time to full oral feed in preterm infants. The one-hundred and nine (109) patient experimental group was given the “pulsing” pacifier therapy and one hundred and one (101) patients were given a non-pulsatile “quiet” pacifier. The key results include:
- The 26 – 30-week gestational age experimental group had a reduction in time to full oral feeds compared to the control group (-4.1 days, p = 0.03). “These very preterm infants reached full oral feed at 35 weeks corrected gestational age.”
- Infants in the 29 - 30-week gestational age sub-experimental group had a significant reduction in time to NICU discharge (-10 days, p < 0.01).”
“This is a pivotal study in the arena of neonatal feeding development and the feeding health market,” said Michael Peck, CEO of Innara Health. “The study conducted by Dr. Song and the incredible team of neonatal researchers demonstrates that NICU infants can achieve better oral feeding outcomes and reduce time on feeding tubes with safe and effective interventional devices while complementing the expertise of neonatal care specialists. The NTrainer is an important health care tool that can impact the lives of NICU infants and their families, and reduce the cost of care.”
About the trial
Full publication text and data of the Patterned Frequency-Modulated Oral Stimulation in Preterm Infants randomized controlled trial can be found at the PLOS ONE journal at http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212675
About the lead investigator
Dongli Song, MD, PhD, is a neonatologist at Santa Clara Valley Medical Center, San Jose, California and an affiliated Associate Professor of Pediatrics at Newborn & Developmental Medicine, Stanford University School of Medicine. Dr. Song has over 30 years of experience in conducting basic and clinical research in neurodevelopmental biology and neonatology.
About Innara Health
Innara Health is a leader in feeding health products and applications and is dedicated to advancing the global understanding and improvement of neonatal feeding. In working towards this goal Innara has developed the FDA cleared NTrainer System®. The NTrainer is an advancement for oral feeding development as it fosters skills essential to the normal development of oral feeding in premature and newborn infants. Innara Health continues to work towards creating cutting edge products that improve standards of care, optimize patient outcomes, and increase healthcare benefits for feeding health.
If you would like more information about this topic, please call Michael Peck at 913-742-4456, or email mpeck@innarahealth.com.