As if things weren’t tough enough for premature babies who have tubes down their throats and noses to survive, once the tubes are removed, they are often unable to take nourishment orally — that is, suck.
But 20 tube-fed preterm infants with respiratory distress syndrome treated with the NTrainer, a therapeutic device patented by the University of Kansas, rapidly learned to suck far better and transitioned to oral feeding faster than a control group of babies with the syndrome.
Respiratory distress syndrome, also known as hyaline membrane disease, is a common condition of prematurity, particularly in the youngest infants, because babies’ lungs are too immature to survive outside the womb without the help of a ventilator and/or oxygen. Overall, it is the seventh leading cause of death among infants younger than one year, fifth for African-American and third for Hispanic infants.
The results of the study were published in the Journal of Perinatology (Nature) and the Acta Paediatrica journal. The initial clinical trial of the NTrainer at the neonatal intensive care units at Stormont-Vail Regional Health Care in Topeka, Kan. and the University of Kansas Medical Center in Kansas City, Kan., compared 20 tube-fed preterm infants with moderate-to-severe respiratory distress syndrome treated with the NTrainer to a control group of age-matched respiratory distress syndrome infants who received a sham consisting of a non-instrumented pacifier during tube feedings.
The NTrainer device powers a Soothie silicone pacifier with a computer-controlled air pump to transform the nipple into a dynamically patterned pulsing touch stimulus on the surface of the infant’s lips and tongue. Modeled extensively on the burst-pause suck dynamics of healthy preterm infants, the NTrainer device essentially teaches babies the correct pattern to produce the “non-nutritive suck,” what they normally do in the womb beginning as early as the second trimester of development.
Infants who received the patterned NTrainer treatment exhibited a near doubling of non-nutritive suck burst complexity, a 50 percent to 100 percent increase on select suck burst production measures and a tripling of their average daily oral feed levels to 72.8 percent compared to the untreated controls at 23 percent. The infants were sampled at 38 weeks postmenstrual age – the time between the first day of mother’s last normal menstrual period and the day of the infant’s delivery.
All of the infants quickly learned to bottle feed, one of the main objectives of Stormont-Vail project partners José Gierbolini, medical director of newborn services, and Joy Carlson, neonatal nurse practitioner.
“We were delightfully surprised at the results,” said KU speech-language-hearing professor Steven Barlow, who directed the study. “This demonstrates the potent effect of the patterned NTrainer orocutaneous stimulation to drive and reorganize the rapidly developing nervous system.“
Barlow, who directs the Communication Neuroscience Laboratories at KU, and University of Colorado professor Donald Finan invented the NTrainer technology (named after the neuroscientific term ‘entrainment’) and its companion technology, the Actifier, a mobile cribside workstation that can be configured to permit real-time assessment of oromotor ability and therapeutic intervention in the premature infant.
“Non-nutritive suck has been suggested by some neonatologists to provide a window into the development of the central nervous system,” said Barlow. “The NTrainer system represents the first objective physiologically based tools that give the physician and nurse almost instant feedback about the status of the infant’s oromotor system through the assessment of NNS.”
For babies born too soon, the development of non-nutritive suck — the precursor behavior to nursing — is often abruptly disrupted by the life-saving but invasive breathing tubes that are inserted down the throat and feeding and oxygen tubes taped to a baby’s nose and face to keep it from thrusting the tubes out.
Besides delaying release from the neonatal intensive care unit, respiratory distress syndrome infants who cannot competently orally feed may be required to continue tube feedings at home, typically by way of a gastric tube. In worst case scenarios, children don’t learn to take nourishment orally for months or even years, according to Barlow.
As an ongoing objective of the study, Barlow’s research team will be examining the effects of NTrainer therapy on infants’ transitions to safely feeding orally and the length of hospital stay.
“In today’s health care environment, being able to send a baby home just one week earlier could save $28,000 to $30,000,” Barlow said.
A newly funded $2.6 million clinical trial awarded to Barlow by the National Institutes of Health is set to begin later this fall and continue over the next five years at Stormont-Vail Regional Medical Center and Overland Park Regional Medical Center. This comprehensive study will examine the effects of early NTrainer intervention on the development of feeding skills, fine motor skills, brain development and the acquisition of speech and language among 240 premature infants followed longitudinally until 3 years of age.
Barlow’s hypothesizes that if the NTrainer can stimulate a specialized brain network known as the suck central pattern generator in infant brains through normal sucking patterns at the right time, approximately 32 weeks gestational age, development can proceed more normally for respiratory distress syndrome babies. Application of the NTrainer may benefit other preterm populations, including infants with bronchopulmonary dysplasia or Down syndrome and very low birthweight preemies at risk for neurologic insults and compromised neurodevelopmental outcome.
The NTrainer system is being developed for market by KC BioMediX Inc. of Shawnee. The NTrainer system received U.S. Food and Drug Adminstration approval in February. The first set of NTrainer production units will be available for the neonatal intensive care market in January.
Barlow is one of the 146 scientists from 20 academic departments affiliated with the Life Span Institute at KU. The Life Span Institute is one of the largest research and development programs in the nation for the prevention and treatment of developmental disabilities. The institute includes 13 centers and more than 140 programs and projects located on the Lawrence campus and KU Medical Center in Kansas City, Kan., and in Overland Park and Parsons.