Pediatrics
Device offers new hope to newborns
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When baby James Pyrih came to the intensive-care nursery Tuesday night with possible brain damage, doctors put a tiny plastic cap filled with cold water on his head.
The baby had suffered from lack of oxygen during birth. Doctors at Thomas Jefferson University Hospital hoped that by lowering his brain temperature a few degrees with the "Cool-Cap," they could reduce the chances that he would become physically or mentally disabled.
Right now, there is little doctors can do to help babies who suffer brain trauma from loss of oxygen during delivery. Cooling is thought to help prevent the damage that occurs when brain cells are deprived of oxygen and begin to die. Researchers believe there is a small window of opportunity after birth to prevent a lifetime of disability.
"If you slow down metabolism and decrease the brain's energy needs, the brain can funnel all its efforts toward healing and repair," said Susan Adeniyi-Jones, a Jefferson neonatologist who has been testing the experimental cap.
The company that makes the Cool-Cap, Olympic Medical Corp., Seattle, has applied to the federal Food and Drug Administration for approval to market the device. The company is scheduled to make its case to an agency panel on June 17, according to Ted Weiler, vice president for research and development.
About one to two of every 1,000 babies in the United States suffer oxygen deprivation at birth. A delivery can be proceeding smoothly until suddenly the placenta begins to tear from the uterus wall or the umbilical cord gets compressed, cutting off the baby's oxygen.
Many babies end up fine. But the damage can be devastating, or even deadly, leading to problems such as mental retardation, cerebral palsy, blindness and learning difficulties.
Up to now, there has not been much to offer babies who suffer a traumatic birth, besides putting them on a respirator and giving medicine to support blood pressure and other functions, said Jay Greenspan, Jefferson's director of neonatology.
A study that tracked the progress of 218 full-term babies who lost oxygen during birth found that 66 percent of those treated conventionally died or had neurological problems at 18 months of age, compared with 55 percent of those who got the cooling cap. The study, done at Jefferson and 24 other medical centers, was published in January in the British medical journal the Lancet. The benefit was even greater when researchers looked at those babies with less severe brain injury to start.
William Walsh, a neonatologist at Vanderbilt Children's Hospital in Nashville who took part in the study, said he tells families that the Cool-Cap is "like putting ice on a finger when you hit it with a hammer."
"You want to decrease the inflammation and swelling and keep the damage from spreading," he said.
Beverly Huff, of Spring Hill, Tenn., said her son, Cullen, got the Cool-Cap at Vanderbilt after doctors predicted he "had about an 80 percent chance of having brain damage."
"Now he's a perfectly normal 5-year-old and starting kindergarten," Huff said.
The concept for the cooling cap was developed by researchers in New Zealand and England, according to Weiler, of Olympic Medical.
Cooling is thought to interfere with the biochemical process that is launched when brain cells are deprived of oxygen.
"What we know is there is the original injury that happens and then there is secondary injury due to the body's reaction to the original injury," said Jacquelyn Evans, a neonatologist at Children's Hospital of Philadelphia who was not part of the study.
"The feeling is that cooling the brain can help prevent the edema and secondary reaction that can further injure the brain," she said.
Researchers have also experimented with whole-body cooling to help reduce brain injury in newborns, but Evans said that approach may be more problematic.
She said Children's Hospital would likely begin to offer the Cool-Cap if it gets FDA approval.
"The results coming from the studies are very encouraging," Evans said. "There are still a lot of unanswered questions."
Theresa and Mark Pyrih, of Holland, Bucks County, expected a routine delivery when they checked into Frankford Hospital-Torresdale Campus in Northeast Philadelphia Tuesday for the birth of their sixth child.
But Theresa began to hemorrhage, and she was rushed to the operating room for a cesarean section.
James was born with no heartbeat and lost a lot of blood. It took doctors and nurses 15 minutes to resuscitate him, according to Jefferson's Greenspan.
The baby was transferred to Jefferson's neonatal intensive-care unit, where he was hooked up to a respirator and monitors.
A test of James' brain function showed diminished activity, and he also was having seizures. Within 25 minutes of the baby's arrival at Jefferson, a tiny plastic cap with water channels was slipped onto his head, and that was covered by an elastic cap and a layer of insulating and heat-reflecting material. Soon cold water was circulating over his scalp.
The cooling cap, which keeps body temperature near 94 degrees, must be placed within six hours of birth and remain on for 72 hours, said Adeniyi-Jones.
James was doing well yesterday. His brain activity showed signs of improvement and the seizures had stopped, Adeniyi-Jones said. Still, it was too soon to say how he'll do in the long run, she said.
James' parents are optimistic.
"At this point, I'm just hoping for life, and anything after that is something we can handle and deal with," Mark Pyrih said. With the Cool-Cap, "what they are doing is offering him something more hopefully."