The tiny premature babies in neonatal intensive care units (NICUs) face unbelievable challenges as they adapt to life in the outside world far before their bodies are ready to survive and thrive independently.
Many survive, thanks to the technology and highly trained NICU teams in the United States and other developed countries. But in low- and middle-income countries where these life-saving treatments are too expensive, many premature infants don’t have a fighting chance.
A small team at Seattle Children’s, including Dr. Tom Hansen, Dr. Skip Smith, Dr. Peter Richardson and Chris Howard, is working to save the lives and improve the outcomes of tiny babies. Thanks to the continuing support of the Bill & Melinda Gates Foundation, these investigators have developed an invention called Seattle Positive Airway Pressure (Seattle-PAP) that promises to improve the odds for premature infants, no matter where they are born.
In the United States, premature infants often rely on a system called Bubble nasal-Continuous Positive Airway Pressure (Bn-CPAP) to breathe with the support of small nasal prongs. However, Bn-CPAP fails to provide enough respiratory support for about half of the infants who need help breathing.
When Bn-CPAP fails, the next step is to have a tube inserted down the airway, so a mechanical ventilator can provide breaths for them. For the parents of these babies, this typically means weeks or even months of watching and waiting to see if their child will get strong enough to transition to CPAP and then to breathing on their own.
But for a baby born in a low-resource country, there is no next step.
“Almost one million infants die every year from respiratory distress, mainly in countries that aren’t able to use devices like mechanical ventilators,” says Hansen. “We think Seattle-PAP has the potential to give infants everywhere a much better chance of surviving because it is far cheaper to produce, operate and maintain than the devices typically used in U.S. healthcare facilities.”
In laboratory testing, the Seattle-PAP invented by the Seattle Children’s team has shown promise to provide greater support than Bn-CPAP, which could mean fewer babies would need mechanical ventilation.
These features make Seattle-PAP ideal for use in areas where access to healthcare resources may be limited. To operate Seattle-PAP, only relatively simple supplies are needed, including water, a continuous air supply, a breathing circuit tube and nasal prongs to fit in the baby’s nose.
Seattle-PAP works like conventional Bn-CPAP devices, which provide continuous positive pressure on the infant’s lungs through tubes inserted in their nostrils. This positive pressure helps infants breathe by preventing their lungs from collapsing.
However, Seattle-PAP may be different from other Bn-CPAP devices because it creates different patterns in the fluctuations in pressure. These fluctuations may decrease the work required from respiratory muscles, making it easier for a baby to breathe.
A Better Option for Infants Everywhere
“The Seattle-PAP could also improve outcomes for infants in NICUs right here in the United States by avoiding intubation and the use of mechanical ventilators or shortening the amount of time infants are intubated,” says Smith.
That’s a big deal if you’re a NICU parent worrying about the challenges that lie ahead: many babies who are intubated develop chronic lung disease, due perhaps in part to tissue damage and inflammation from being intubated and on a mechanical ventilator. Their growth may be limited by steroids that are given to strengthen their lungs enough to decrease their respiratory support. They also may require feeding tubes because they aren’t able to breathe well enough to breastfeed or bottlefeed during the crucial window when babies are best able to learn.
Thanks to a $3 million grant recently awarded by the Bill & Melinda Gates Foundation, the Seattle-PAP team will conduct two clinical trials at Texas Children’s Hospital to take their invention from the laboratory to their first patients.
The first trial, slated to start in spring 2014, is designed to determine whether premature infants will breathe more easily with Seattle-PAP than Bn-CPAP, replicating the team’s findings in previous studies in experimental animals. The second trial will determine whether using the Seattle-PAP results in less need to intubate infants and use mechanical ventilation than with current practice using standard Bn-CPAP.
In October 2013, Seattle-PAP received clearance from the Food and Drug Administration for use and distribution in the U.S. The Seattle-PAP team is waiting with great anticipation for the moment when the device is placed on the first infants to see if it makes a difference not only in the laboratory, but when it really matters.