Friday, May 2, 2008

New cooling device helps treat babies

[Source: Ken Alltucker, The Arizona Republic] - Timing is everything for newborn Macie Chloe Reynolds.

A persistent doctor, loving parents and a life-changing technology certainly help, too.

This week, Macie became the first newborn at an Arizona hospital to be treated with the "cool-cap" machine, a new device that aims to help otherwise healthy, full-term infants recover from traumatic deliveries.

Macie appeared healthy and in good spirits Thursday following 72 hours of cool-cap machine treatments. And her parents were cautiously optimistic that their nine-pound, six-ounce baby girl would be the first of many Arizona infants to benefit from the new technology now available at Phoenix Children's Hospital.

"There is a light at the end of the tunnel," said Kevin Reynolds, Macie's father. "We just don't know how long the tunnel is."

Phoenix Children's Hospital is the first Arizona hospital to use the Olympic Cool-Cap device. The machine is used on newborns, such as Macie, that face complications due to a lack of oxygen during birth, a condition known as hypoxic-ischemic encephalopathy. The condition can devastate babies and their families, causing such disabilities as dyslexia, cerebral palsy and even death. The cool-cap machine works to lower the infant's brain temperature to help counteract complications.

The whirlwind week for the Reynolds' took an unexpected turn Monday morning as mother Tarin had to undergo an emergency cesarean section due to complications with her pregnancy at Banner Gateway Hospital in Gilbert. Her placenta had separated before the baby was born, cutting off the baby girl's oxygen.

Macie was delivered shortly before 7 a.m. but she was not out of the woods. She was flown via medical helicopter from Banner Gateway to Phoenix Children's Hospital for treatment. Phoenix Children's had installed the cool-cap machine just last week.

"Before, if the baby had a brain injury at birth, there would be nothing we could do," said Dr. Cristina Carballo. "This is such an incredible thing to be able to do."

Carballo had learned about the cool-cap system from clinical trials that showed the device was safe and effective. It is the only Food and Drug Administration-approved device designed to aid infant brain injuries caused by a lack of oxygen. After learning about the device's potential impact, Carballo prodded the hospital's administration to purchase the device and related equipment.

Natus Medical, the San Carlos, Calif.-based company that sells the Oympic Cool Cap, gained FDA approval in February to sell the device in the United States. It's now used in fewer than 200 Level 3 neonatal intensive care units in the United States, company executives said.

Phoenix Children's is the only hospital in Arizona with the device, though a spokesman for Banner Children's hospital at Banner Desert in Mesa expects the hospital will soon consider purchasing the cool-cap system.

The device works by keeping the infant's brain cool while the rest of the body remains about three degrees below normal body temperature. It includes a helmet-like shell that is placed over the baby's head, and tubes circulate cold water through the cap for a cooling effect.

The overall system, which retails for about $75,000, includes a cooling unit, a control unit, temperature probes and the water-filled cap.

The condition hypoxic-ischemic encephalopathy, or HIE, occurs in an estimated two to four times out of every 1,000 births. The FDA estimates that the cool-cap device could annually help 5,000 to 9,000 babies in the United States. It should help at least five to six babies each year in the Phoenix area, Carballo estimates.

As Macie arrived at Phoenix Children's Monday morning, Kevin Reynolds said he experienced a swirl of emotions. His wife was still at Banner, following the difficult birth, and his daughter would become the first baby to undergo the cool-cap treatment in Arizona.

"I was overcome by the fact that I didn't know what was going to happen," said Reynolds, a Gilbert resident and high school Spanish teacher.

Time is critical in births, such as Macie's. The infant must be treated by the cool-cap within six hours of birth, and typical newborn procedures, such as putting the baby under a heat lamp, must be avoided.

Macie was put on the system within the required time and remained on the machine until just before noon Thursday. Her body temperature was gradually elevated to normal levels within four hours.

Macie will stay at Phoenix Children's for observation. Her mother, Tarin, arrived at her baby's side Wednesday.

Despite the stressful period, the Reynolds' said they look forward to soon returning home with their baby girl.

"You are going to do everything you possibly can do to help your child," Reynolds said.

Reach the reporter at ken.alltucker@arizonarepublic.com or (602)444-8285.

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