Support from the NIH allowed researchers to comprehend, predict, and prevent breathing disruptions in infants with apnea of prematurity and neonatal opioid withdrawal syndrome
Part of the Wyss Institute’s series on the positive, life-altering impact of federal research funding
By Jessica Leff
About half of premature infants suffer from sleep apnea, which involves pauses in their breathing. Apnea of prematurity can be life-threatening, as it lowers heart rates to dangerous levels, and can even be a risk factor for sudden infant death syndrome (SIDS). Conversely, opioid-exposed newborns can suffer withdrawal symptoms, such as rapid heart rate, which in turn can cause breathing disruptions. Both conditions typically require that babies be closely monitored in the hospital until they can breathe normally on their own.
As a young medical student, David Paydarfar, M.D., who would later become an Associate Faculty member at the Wyss Institute, witnessed those breathing pauses firsthand. His supervisor, the attending physician, told him there was no evidence that these disruptions meant anything, and a week after discharging an infant patient, they died of SIDS. This experience put Paydarfar on a decades-long path to understand this phenomenon and find a way to save future babies.
With the help of government funding, Paydarfar and his collaborators developed an innovative solution to stabilize cardiorespiratory function more effectively and improve neonatal health.
Keeping the airways clear
When considering this problem, Paydarfar recalled a lecture by Arthur Winfree he attended, where Winfree, a theoretical biologist, explained his mathematical model for understanding the impact of a stimulus on an oscillation pattern. Researchers had begun studying this phenomenon in plants and small animals, like fruit flies, but Paydarfar wondered if it applied to mammalian breathing.
While still at the University of North Carolina School of Medicine, Paydarfar applied to the National Institute of Health (NIH) for funding that would allow him to test his theory. He explains, “Jumping right into a mammal was a weird idea, but my mentor believed in me and the NIH said, ‘It’s not as crazy as it might sound. Let’s try it.’ In some ways, the rest is history.” Early experiments confirmed the idea that mammalian breathing did follow Winfree’s model.
Jumping right into a mammal was a weird idea, but my mentor believed in me and the NIH said, ‘It’s not as crazy as it might sound. Let’s try it.’ In some ways, the rest is history.
By 1993, Paydarfar had moved to Massachusetts and was a staff neurologist and Chief of Neurology at St. Elizabeth’s Medical Center. The NIH awarded the hospital a grant to investigate whether irregular breathing rhythms could be induced by stimuli that affect the natural respiratory cycle at a certain time, with Paydarfar as the Principal Investigator. In studying the instability of respiratory stimulation in premature infants, the team found that infants can still suffer from periods of low oxygenation, even if their breathing rhythms are stable. That showed them that even placing infants on a ventilator wouldn’t completely solve the problem. They needed another idea.
Ten years later, the NIH awarded a $1.1M grant to University of Massachusetts (UMass) Medical School, where Paydarfar had become a professor and the Executive Vice Chair of the Department of Neurology, to investigate how the nervous system controls swallowing and airway protection in order to understand the mechanisms of neuronal dysphagia, a difficulty swallowing, and aspiration, or inhaling foreign materials. The researchers, thinking that neuronal dysphagia could share commonalities with apnea, determined how the primary sensory nerve of the larynx regulates swallowing and then used that knowledge to improve mechanisms for swallowing in patients with dysphagia and aspiration due to cerebral lesions.
In 2007, the NIH granted $1.97M for scientists led by Paydarfar to gain a better understanding of infant cardiovascular control. His team analyzed physiological signals from neonates suffering from apneas, hypoxia, and changes in heart rate and used their findings to develop statistical models of instability that eventually allowed them to predict when a disruption of respiratory function would occur.
Paydarfar shares another example of federal government support: “There was one researcher on my team, Elisabeth Bloch Salisbury, who was supported by NIH Re-entry into Biomedical and Behavioral Research, which is a program specifically designed to help researchers who previously left the field and now wish to return. She was incredibly passionate about this work.”
Together, these foundational grants allowed researchers to understand and model the behavior of “pacemaker” neurons in neonates. These neural pacemakers are responsible for maintaining normal respiration and heart rate. They are still maturing at birth, especially in premature babies, which leaves infants vulnerable to life-threatening disruptions in breathing. The researchers found that when infants’ pacemaker neurons were stimulated via a MacGyvered vibrating mattress, neonates were less likely to experience apneic events.
We know the problem, how do we fix it?
In 2009, the same year the Wyss was founded, Paydarfar gathered an interdisciplinary team of researchers from the Institute to build and test the next generation of therapeutic mattress pads that could stabilize the function of pacemaker neurons to avoid apnea altogether by providing stochastic, randomly probable, gentle vibrations.
Recognizing that other infants suffered from breathing disruptions, the team explored other applications of the therapeutic mattress pad. Of particular interest were infants with Neonatal Opioid Withdrawal Syndrome (NOWS). These babies are born to mothers who fell victim to the opioid epidemic, and are also vulnerable to breathing disruptions. The NIH was equally intrigued, and in 2013, they awarded $469,500 to a UMass Medical School team led by Bloch-Salisbury to investigate whether the same kind of vibrations could stabilize opioid-exposed newborns. Clinicians collaborated with the Wyss team, who were fabricating the device, to test its efficacy.
Paydarfar is now the Chair of the Department of Neurology at The University of Texas at Austin Dell Medical School. He is also a professor in the Department of Neurology and the Director of the Mulva Clinic for the Neurosciences.
The path to translation
After the success of these studies, the Wyss team began a business development push, and after several attempts to commercialize the technology, they eventually brought on John Konsin as a startup advisor. In 2018, Konsin, Paydarfar, and now Wyss Senior Director of Translational R&D, James Niemi, co-founded Prapela to commercialize the gently vibrating mattress pad. The startup licensed patents and know-how based on the predictive and therapeutic work funded by the NIH. Konsin is the CEO and Principal Owner of Prapela.
The company continued to receive government support, securing over $2.7M in grants from the NIH for both Phase I and Phase II Small Business Innovation Research (SBIR) studies. After Prapela received Breakthrough Device Designation for the mattress’s use in treating apnea of prematurity and NOWS in the intervening years, in 2025, the FDA granted De Novo clearance to the vibrating mattress pad for the first indication treating NOWS infants.
Both the NIH and the Wyss were necessary, but not sufficient. The NIH supported the early work, and then the Wyss came in to further de-risk the technology, preparing it for industry. Now, it’s come full circle where we’re getting SBIR funding from the NIH.
“None of this could have happened without the NIH or the Wyss,” explains Paydarfar. “Both were necessary, but not sufficient. The NIH supported the early work, and then the Wyss came in to further de-risk the technology, preparing it for industry. Now, it’s come full circle where we’re getting SBIR funding from the NIH.”
To develop life-saving technologies, researchers must first understand how the human body works and what causes its functions to break down. Without the early funding, scientists would not have understood how infants maintain a normal breathing rhythm and therefore wouldn’t have known how to predict and ultimately prevent disruptions. Foundational research lays the groundwork for future medical innovations.
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