Clinical study of Penn State Hershey technology begins in South Africa

August 25, 2003

The first clinical study of the neonatal chest wall stabilizer developed at Penn State Hershey Medical Center recently began at three hospitals in Johannesburg, South Africa.

Charles Palmer, M.B., Ch.B., device inventor and professor of pediatrics, Penn State College of Medicine, spent two weeks in August in South Africa where he trained medical staff to use the chest wall stabilizer, a device that allows babies with respiratory distress to breathe easier.

"Although the device could be an option for babies who need help with breathing in technologically-advanced hospitals like those in the United States, it could be particularly useful in developing countries where more expensive medical options are unavailable or in short supply," Palmer said.

The chest wall stabilizer was designed for premature babies who have underdeveloped, unstable chest walls that retract or buckle inward with each breath, making it difficult for them to breathe and get adequate oxygen. Palmer's lightweight device wraps around the chest wall and fastens to the skin of the chest and back with a non-irritating, water-soluble adhesive. The device is non-invasive, provides stability to the rib cage, restores the chest shape, permits chest expansion and has already been shown to allow easier breathing. Most importantly, this small device allows parents to hold the baby while they grow and heal.

The technology was recently patented and then licensed by Penn State to Respironics Inc., of Murraysville, Pa. Respironics is further developing it under the name, Hug 'n' Snug* Neonatal Chest Splint.

Although tested on an experimental basis in the United States, the first clinical study is taking place in South Africa where Palmer hopes the device will be available as soon as possible to help babies who do not have as many options as those in the United States. In the U.S., babies who are suffering from respiratory distress are given a substance called surfactant as well as continuous positive airway pressure (CPAP). If this combination doesn't give the baby enough breathing support, the baby may be put on mechanical ventilation.

However, in South Africa, babies do not get CPAP or surfactant on a routine basis and when they do, it's much later when the children are already very sick.

"One reason is that CPAP requires intensive nursing, and in some parts of South Africa, nursing shortages preclude the use of CPAP until a baby is very ill," Palmer said. "Another problem is the shortage of mechanical ventilators for those children who have very severe cases of respiratory distress. Many kids who don't recover with the other options cannot get access to mechanical ventilators and many die."

This study will evaluate whether providing early chest wall stabilization with the device will prevent lung collapse, enable these babies to breathe easier on their own and avoid mechanical ventilation.

"We hope this study finds that the chest splint is a simple, inexpensive alternative that can be used in a low intensive care neonatal nursery to help babies," he said.

Palmer is a founding member of the Pediatric Innovation Program, a unique collaboration of Penn State Children's Hospital, Penn State University and industrial partners that focuses on improving the development of technology for infants and children. The program provides a forum for clinicians, engineers, and industry to exchange ideas with the goal of innovating clinically relevant technology for rapid translation into clinical solutions.

"We believe that resources spent on improving health at the start of life are truly resources well spent in the prevention of life-long handicap," Palmer said. "Improvement of the level of care given to our most vulnerable patients will only give those little people a better chance at a long and happy life."
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Penn State

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