FDA Approves Head-Cooling Device to Treat Newborn Brain Disorder

FDA Approves Head-Cooling Device to Treat Newborn Brain Disorder
ROCKVILLE, Md., Dec. 20 -- The FDA today approved Olympic Cool-Cap, a device that cools the head to prevent damage caused by neonatal hypoxic-ischemic encephalopathy (HIE), a condition that affects 5,000 to 9,000 newborns each year.

The agency said Cool-Cap was indicated for treatment of moderate to severe HIE. The device keeps the head cool while the body is maintained at a slightly below-normal temperature.

In making the announcement, Daniel Schultz, M.D., director of the FDA's Center for Devices and Radiological Health, said until now HIE treatment was limited to supportive care.

He said historically about 20% of HIE babies died and another 25% suffered permanent disability because of neurological deficits.

The Olympic Cool-Cap treats the patient by maintaining a steady flow of water at a selected cool temperature through a cap covering the infant's head.

The system, which consists of a cooling unit, a control unit, temperature probes and a water-filled cap, was found safe and effective in a study with 234 infants with moderate to severe HIE. At 18 months of age, there were fewer deaths and fewer severe cases of neurodevelopmental disability in the cooled group compared with the control group.

As a condition of the approval, Olympic Medical Corporation of Seattle, maker of the device, will set up a patient registry to collect information on device usage and to track treatment outcomes.

The company will also organize a training and certification process for all operators of the device.

The FDA also directed Olympic to restrict the use of the device to patients who meet the eligibility criteria defined by the original study.

Fish oil during pregnancy could boost baby's coordination

Fish oil during pregnancy could boost baby's coordination

Women who take high doses of fish oils during pregnancy could dramatically boost their children's coordination, say researchers.

A new study reveals the benefits of using so-called "clever capsules" to help develop the full potential of babies while still in the womb

It found a significant advance in hand-eye coordination among toddlers whose mothers took fish oil supplements during the second half of pregnancy compared with those who did not.

The last three months of pregnancy are thought to be a key time for intake of fish oil because there is a growth spurt in the human brain during this time, which carries on into the first few months of a baby's life.

Other research suggests cod liver oil taken during pregnancy may increase birthweight and reduce the risk of the baby developing type 1 diabetes.

But as well as immediate benefits to the child, studies show fish oils can help mums-to-be in a number of ways, including reducing high blood pressure and easing post-natal depression.

The latest study from the University of Western Australia looked at 98 pregnant women, who were either given 4g of fish oil supplements or 4g of olive oil supplements daily from 20 weeks of pregnancy to the bith of their babies.

When the children reached the age of two and a half, they were given various tests measuring growth and development.

Children whose mothers had taken fish oil supplements scored significantly higher in hand-eye coordination than those whose mothers had taken olive oil supplements.

The last three months of pregnancy are thought to be a key time for intake of fish oil because there is a growth spurt in the human brain during this time, which carries on into the first few months of a baby's life.

Other research suggests cod liver oil taken during pregnancy may increase birthweight and reduce the risk of the baby developing type 1 diabetes.

But as well as immediate benefits to the child, studies show fish oils can help mums-to-be in a number of ways, including reducing high blood pressure and easing post-natal depression.

The latest study from the University of Western Australia looked at 98 pregnant women, who were either given 4g of fish oil supplements or 4g of olive oil supplements daily from 20 weeks of pregnancy to the bith of their babies.

When the children reached the age of two and a half, they were given various tests measuring growth and development.

Children whose mothers had taken fish oil supplements scored significantly higher in hand-eye coordination than those whose mothers had taken olive oil supplements.

Savvy squirrels outwit trees

Like good stock brokers, red squirrels predict when the market will be flooded with seeds and then invest big by producing a second litter of young, a new study finds.

"Lots of animals time their reproduction to match predictable increases in resources like the new growth of plants every spring," said lead researcher Stan Boutin of the University of Alberta. "But the interesting twist here is that these squirrels have figured out a way to produce this second litter of babies at a time when they have little food and before an ‘unpredictable’ boom in seed production.”

The results are detailed in the Dec. 22 issue of the journal Science.

Smart squirrels
Boutin and his colleagues monitored two species of red squirrels, including a natural population of American red squirrels in southwestern Yukon, Canada from 1987 to 2004, and Eurasian red squirrels in Belgium and Italy.

Somehow the squirrels could anticipate when the trees would be laden with cones, and only during these years they produced a second litter of young.

In addition to predicting the future, the squirrels were able to reproduce while females were breast-feeding the first litter — something that doesn't normally occur in mammals, said study team member Andrew McAdam of Michigan State University.

While the researchers still aren’t certain how the squirrels can predict the cone market from year to year, they think it might be some chemical or visual cue from the buds that ultimately form tree cones. Every summer the squirrels nibble on these buds. "Squirrels could be using a visual cue or a hormonal cue they gain from eating the buds," Boutin said.

Russia secures control of key Siberian project

Russia secures control of key Siberian project
The Russian state-controlled natural gas giant Gazprom is to take a 50% plus one share stake in the Shell-operated Sakhalin-2 energy project. The deal was signed at a Kremlin meeting between President Vladimir Putin and top executives from Shell and Gazprom along with officials from the project's Japanese shareholders.

Putin said: "With regard to the Sakhalin-2 project, I am aware that a few years ago Shell had already invited Gazprom to take part. The Russian government is interested in realising this project as much as its investors are. And I would like to thank you for the flexibility that you expressed in the course of these negotiations."

The new ownership leaves Shell with 27.5% and of its Japanese partners, Mitsui get to keep 12.5% and Mitsubishi 10%.

The budget has risen to 17 billion euros and the site has estimated reserves of 45 billion barrels of oil.

The deal ends a year long campaign in which Moscow threatened to take away Shell's permits on environmental grounds and to block investment plans unless Gazprom was allowed to join the project.