FDA Approves Treatment & Kidsta Mask for Kids

SteveGrenard · 13th May 2006, 10:22 AM

Many children with learning disabilities, others labeled as having attention deficit disorder, are sometimes the victims of undiagnosed and untreated sleep disordered breathing (SDB).

SDB interferes with normal sleep leading to excessive daytime
sleepiness and all that it entails in terms of learning or otherwise normal functioning. Up to now the only "legal" treatment for kids in the U.S. was to enlarge their airways with surgery for removal of tonsils and adenoids (which can be a problem causing SDB). CPAP, which is used routinely in adults, had to be used only in children weighing over 40 kgs or prescribed off-label with informed, formal consent.

The recent epidemic of childhood obesity makes SDB worse.

Press Release

Quote:

ResMed Corp ( http://www.resmed.com/ ), San Diego, announced thatthe US Food and Drug Administration (FDA) has cleared its pediatric positive airway pressure (PAP) system for domestic use. Its Mirage Kidsta nasal mask and the VPAP® III ST-A bilevel ventilator system combo was approved for
treating children 7 years and older that weigh more than 40 lbs in the hospital and home. The Mirage Kidsta is based on ResMed's Mirage mask for adults and has the same dual-wall cushion technology and design as the adult
mask. The VPAP III ST-A has been available to adult patients since 2004 and ResMed expects the Mirage Kidsta mask to ship in late summer.

"Pediatric specialists are increasingly aware of the prevalence and symptoms of sleep apnea and they recognize the need for suitable therapy options for their pediatric patients," said Rochelle Turetsky, MD, of Gaylord Hospital in Wallingford, Conn, in a statement provided by ResMed.
"As a result, pediatricians have seen an increasing and unmet need for an approved pediatric device. ResMed's recent FDA clearance of a full therapy system for pediatric use in the hospital and home is excellent news for patients and physicians and will meet a growing need in pediatric
practices."

We have already been supporting pediatric patients with the Mirage Kidsta in Canada and Latin America; now,
we have the only bilevel system FDA cleared for pediatric use in the hospital and home.

We have an extraordinary opportunity to provide a complete treatment system to a previously under-supported patient group in the United
States."

The Mirage Kidsta has been commercially available in Europe since 2004. It has been used to treat patients in Germany, France, the United Kingdom and other countries, ResMed said.

http://resmed.com/portal/site/ResMed...1&vgnPNum=null

Goshawk · 13th May 2006, 10:36 AM

Boy, I'd sure rather see kids diagnosed with learning disorders being treated with these as a first line of defense, rather than drugs. IMO "Let's help you sleep better and see if that helps" is much more desirable than "Let's automatically throw some ADHD drugs at you and assume that that will fix what's wrong with you".

SteveGrenard · 13th May 2006, 12:11 PM

Originally Posted by Goshawk

Boy, I'd sure rather see kids diagnosed with learning disorders being treated with these as a first line of defense, rather than drugs. IMO "Let's help you sleep better and see if that helps" is much more desirable than "Let's automatically throw some ADHD drugs at you and assume that that will fix what's wrong with you".

Can't disagree when you consider the drugs used to treat ADHD: Ritalin,(methylphenidate) Adderall (dextroamphetamine sulfate) and Dexedrine (and Strattera.)

While these stimulants (Strattera is classed as a non-stimulant) work through their paradoxical effect, quieting down hyperactive children, if a child's daytime symptoms of attention deficit and hyperactivity are due to poor sleep quality, then it makes a whole lot more sense to check for this first. I have parents whose kids have been diagnosed with sleep apnea and who either had their tonsils removed (and came back to be tested afterwards to see if this "fixed" them)or were placed on CPAP therapy who have had remarkable turn-arounds in progress in school as well as socially. Any kid who is a "noisy" breather at night when sleeping should be considered first for this. Throwing these pills at kids is an easy out. It should be a last resort.

Dr. Imago · 13th May 2006, 01:25 PM

I'm not exactly sure what the root cause of the pervasive (dare I say epidemic) of ADHD diagnosis is. I've met children in the clinic, just one the other day in fact (non-medicated too), who have been labeled with this diagnosis and clearly did not meet the criteria. Perhaps some of this is the cause, perhaps some overdiagnosis of normal childhood behavior is at play, maybe it's a simple cause/effect phenomenon of our sedentary, tv-saturated, laissez-faire culture that has vastly changed in the past 30 years producing the "wired" little children. I really don't know, but the American Academy of Pediatrics is very concerned and suggests that there should be no television before the age of 2, and limited amounts thereafter.

As far as kiddie BiPAP... hmmm... perhaps parents should feed their children better so as not to have morbidly obese little couch-potato monsters who are out of control because all the do is sit around and become overstimulated by video games and flashy TV programs, rewiring their brains to have "high stimulation" become a baseline threshold, and then wonder why they are hyperactive. What ever happened to reading and growing your imagination, playing outside, and actually having to figure out ways to have fun?

I can't help but think that we, as adults and parents, are primarily responible for doing this to our children, and that all the Ritalin, BiPAP, therapy, and behavior modification isn't going to change things much until we modify our behavior and ultimately remember who is the parent in the parent-child relationship.

-Dr. Imago

SteveGrenard · 13th May 2006, 01:39 PM

I agree with everything you say. PAP therapy is NOT for every child. There is the decision to do a T&A and see if that works ..if the child had OSA on initial testing. The American Academy of Pediatrics also came out with a concensus statement a couple years back saying if the child snores they should be evaluated for OSA. PAP in kids should be reserved for those in whom surgery did not work or is not an option (e.g. normal tonsils and adenoids) and for kids that test positive for OSA on overnight polysomnography. Childhood obesity is definitely a factor. I can't believe we see 11 year olds who outweigh adults. What next, pediatric lap-band surgery?

13th May 2006, 10:22 AM	#1
SteveGrenard Philosopher Join Date: Oct 2002 Location: Wherever the airline sends my luggage Posts: 5,528	FDA Approves Treatment & Kidsta Mask for Kids Many children with learning disabilities, others labeled as having attention deficit disorder, are sometimes the victims of undiagnosed and untreated sleep disordered breathing (SDB). SDB interferes with normal sleep leading to excessive daytime sleepiness and all that it entails in terms of learning or otherwise normal functioning. Up to now the only "legal" treatment for kids in the U.S. was to enlarge their airways with surgery for removal of tonsils and adenoids (which can be a problem causing SDB). CPAP, which is used routinely in adults, had to be used only in children weighing over 40 kgs or prescribed off-label with informed, formal consent. The recent epidemic of childhood obesity makes SDB worse. Press Release Quote: ResMed Corp ( http://www.resmed.com/ ), San Diego, announced thatthe US Food and Drug Administration (FDA) has cleared its pediatric positive airway pressure (PAP) system for domestic use. Its Mirage Kidsta nasal mask and the VPAP® III ST-A bilevel ventilator system combo was approved for treating children 7 years and older that weigh more than 40 lbs in the hospital and home. The Mirage Kidsta is based on ResMed's Mirage mask for adults and has the same dual-wall cushion technology and design as the adult mask. The VPAP III ST-A has been available to adult patients since 2004 and ResMed expects the Mirage Kidsta mask to ship in late summer. "Pediatric specialists are increasingly aware of the prevalence and symptoms of sleep apnea and they recognize the need for suitable therapy options for their pediatric patients," said Rochelle Turetsky, MD, of Gaylord Hospital in Wallingford, Conn, in a statement provided by ResMed. "As a result, pediatricians have seen an increasing and unmet need for an approved pediatric device. ResMed's recent FDA clearance of a full therapy system for pediatric use in the hospital and home is excellent news for patients and physicians and will meet a growing need in pediatric practices." We have already been supporting pediatric patients with the Mirage Kidsta in Canada and Latin America; now, we have the only bilevel system FDA cleared for pediatric use in the hospital and home. We have an extraordinary opportunity to provide a complete treatment system to a previously under-supported patient group in the United States." The Mirage Kidsta has been commercially available in Europe since 2004. It has been used to treat patients in Germany, France, the United Kingdom and other countries, ResMed said. http://resmed.com/portal/site/ResMed...1&vgnPNum=null
	__________________ "We are facing a neurosis at the level of an entire civilization” Pierre Rehov

13th May 2006, 12:11 PM	#3
SteveGrenard Philosopher Join Date: Oct 2002 Location: Wherever the airline sends my luggage Posts: 5,528	Originally Posted by Goshawk Boy, I'd sure rather see kids diagnosed with learning disorders being treated with these as a first line of defense, rather than drugs. IMO "Let's help you sleep better and see if that helps" is much more desirable than "Let's automatically throw some ADHD drugs at you and assume that that will fix what's wrong with you". Can't disagree when you consider the drugs used to treat ADHD: Ritalin,(methylphenidate) Adderall (dextroamphetamine sulfate) and Dexedrine (and Strattera.) While these stimulants (Strattera is classed as a non-stimulant) work through their paradoxical effect, quieting down hyperactive children, if a child's daytime symptoms of attention deficit and hyperactivity are due to poor sleep quality, then it makes a whole lot more sense to check for this first. I have parents whose kids have been diagnosed with sleep apnea and who either had their tonsils removed (and came back to be tested afterwards to see if this "fixed" them)or were placed on CPAP therapy who have had remarkable turn-arounds in progress in school as well as socially. Any kid who is a "noisy" breather at night when sleeping should be considered first for this. Throwing these pills at kids is an easy out. It should be a last resort.
	__________________ "We are facing a neurosis at the level of an entire civilization” Pierre Rehov Last edited by SteveGrenard; 13th May 2006 at 12:28 PM.

13th May 2006, 01:25 PM	#4
Dr. Imago Graduate Poster Join Date: Aug 2001 Posts: 1,918	I'm not exactly sure what the root cause of the pervasive (dare I say epidemic) of ADHD diagnosis is. I've met children in the clinic, just one the other day in fact (non-medicated too), who have been labeled with this diagnosis and clearly did not meet the criteria. Perhaps some of this is the cause, perhaps some overdiagnosis of normal childhood behavior is at play, maybe it's a simple cause/effect phenomenon of our sedentary, tv-saturated, laissez-faire culture that has vastly changed in the past 30 years producing the "wired" little children. I really don't know, but the American Academy of Pediatrics is very concerned and suggests that there should be no television before the age of 2, and limited amounts thereafter. As far as kiddie BiPAP... hmmm... perhaps parents should feed their children better so as not to have morbidly obese little couch-potato monsters who are out of control because all the do is sit around and become overstimulated by video games and flashy TV programs, rewiring their brains to have "high stimulation" become a baseline threshold, and then wonder why they are hyperactive. What ever happened to reading and growing your imagination, playing outside, and actually having to figure out ways to have fun? I can't help but think that we, as adults and parents, are primarily responible for doing this to our children, and that all the Ritalin, BiPAP, therapy, and behavior modification isn't going to change things much until we modify our behavior and ultimately remember who is the parent in the parent-child relationship. -Dr. Imago
	__________________ DISCLAIMER: The above post is for informational and/or educational purposes only. It is not a substitute for the professional judgment of, in direct consultation with, a health care professional in diagnosing, treating, and/or preventing any disease or disorder. It is not to be construed as individualized medical advice, diagnosis, or a treatment recommendation. Your reliance upon the information obtained or used by you at, through, or as a result of this post is solely at your own risk.

13th May 2006, 01:39 PM	#5
SteveGrenard Philosopher Join Date: Oct 2002 Location: Wherever the airline sends my luggage Posts: 5,528	I agree with everything you say. PAP therapy is NOT for every child. There is the decision to do a T&A and see if that works ..if the child had OSA on initial testing. The American Academy of Pediatrics also came out with a concensus statement a couple years back saying if the child snores they should be evaluated for OSA. PAP in kids should be reserved for those in whom surgery did not work or is not an option (e.g. normal tonsils and adenoids) and for kids that test positive for OSA on overnight polysomnography. Childhood obesity is definitely a factor. I can't believe we see 11 year olds who outweigh adults. What next, pediatric lap-band surgery?
	__________________ "We are facing a neurosis at the level of an entire civilization” Pierre Rehov Last edited by SteveGrenard; 13th May 2006 at 01:42 PM.

13th May 2006, 10:36 AM	#2
Goshawk Graduate Poster Join Date: Jan 2003 Location: Decatur, Illinois, USA Posts: 1,319	Boy, I'd sure rather see kids diagnosed with learning disorders being treated with these as a first line of defense, rather than drugs. IMO "Let's help you sleep better and see if that helps" is much more desirable than "Let's automatically throw some ADHD drugs at you and assume that that will fix what's wrong with you".