[U.S. Food and Drug
Administration]

This article was published in FDA Consumer magazine several years ago. It is no longer being maintained and may contain information that is out of date. You may find more current information on this topic in more recent issues of FDA Consumer or elsewhere on the FDA Website, by checking the site index or home page, or by searching the site.
Infant Apnea Monitors Help Parents Breathe Easy 
by Dori Stehlin 

It's a rare mother who hasn't tiptoed into her sleeping baby's room and 
listened just to make sure that tiny chest is moving in a gentle breathing
rhythm. 

Occasionally, though, that gentle rhythm is broken by periods of stopped
breathing. As frightening as that may sound, a temporary pause from breathing,
or apnea, is not always cause for alarm.

"All babies pause in their breathing," says Robert G. Meny, M.D., a 
pediatrician with the University of Maryland Medical School's Sudden Infant 
Death Syndrome Institute. "Especially after a sigh, a pause of maybe five 
seconds or eight seconds, depending on the baby, is completely normal." 

Meny adds that "when a baby moves around a lot, you'll very often see that the
child does not breathe for 10 to 15 seconds. That, too, is normal.

"The question is not if--the question is how much, how often, and how long. I 
begin to worry especially when I see the pauses for more than 20 seconds."

Apparent Life-Threatening Events

Twenty seconds. That's the point at which apnea does become cause for alarm.
When apnea lasts for more than 20 seconds, the baby may begin to turn blue or 
pale, choke or gag, and go limp. A pause in breathing for less than 20 seconds
may also be serious if the heart rate slows significantly.

The official medical term for serious episodes of prolonged apnea that don't
result in death is Apparent Life-Threatening Event or ALTE. Babies can be 
saved if the prolonged apnea is detected quickly enough.

"There are a whole variety of responses to apnea of 20 seconds or more," says 
Meny. "Very often the baby will respond to mild stimulation--a flick of the 
fingers on the feet or something like that. If that doesn't do the trick, then
the next step is vigorous stimulation, where you give the baby a painful
stimulus like a good pinch. And finally, if that doesn't work, then the parent
would go to mouth and nose resuscitation."

Do not shake the baby, Meny warns. Infants do not have good head control, and 
vigorous shaking could cause head injury and even death.

In some cases, the episode of prolonged apnea can be traced to a specific 
problem such as infection, airway obstruction, heart disease, seizure, or 
choking, says John G. Brooks, M.D., professor of pediatrics at the University 
of Rochester Medical School. He adds that in approximately half the cases,
however, no specific cause is identified. 

When the cause isn't known, there is no known cure for infant apnea except
time. The number of apnea episodes decreases as the baby gets older, and "in
most cases, the problem is no longer medically significant after the child is 
6 months old," says Brooks. 

Apnea Monitors

But until this time, many infants younger than 6 months who have experienced
an ALTE are put on a home apnea monitor. The main function of these monitors
is to sound an alarm if the baby stops breathing. 

There are three types of infant apnea:

  Central or diaphragmatic--the baby makes no effort to breathe; the chest is 
still, and no air passes through the mouth or nose. 

  Obstructive--the chest is moving but no air passes through the mouth or nose
(usually due to soft tissue such as the tongue blocking the upper airway).

  Mixed--the infant has episodes of both central and obstructive all within 
the same event. 

The variations in types of apnea complicate the function of the monitor. For
example, if the apnea is obstructive, the chest will continue to move. If the 
monitor's only method of detecting breathing is chest movement, this type of
apnea might go undetected.

For that reason, effective apnea monitors also measure a physiological
function that is adversely affected within a relatively short time after the
baby stops breathing. Currently, the function most monitors measure is heart
rate. Normally, the monitor's alarm is set to go off if the baby stops
breathing for 20 seconds or if the heart rate slows to less than 80 beats per 
minute. 

Government Standards

FDA is developing a mandatory performance standard for infant apnea monitors. 
At press time, the requirements for this standard were not final. 

Many features the agency considers to be mandatory on monitors are already
available on some models. Under the tentative performance standard, all 
monitors must be able to detect both a physiological problem that results from
apnea, such as slow heart rate, as well as the absence of breathing. Some of
the other requirements FDA may require include: 

  battery back-up that can supply power for at least eight hours

  both audio and visual alarms

  sensors that can detect improper equipment performance, such as damaged 
electrodes and disconnected or improperly connected lead wires

  safeguards that prevent inadvertent or unauthorized disabling of the alarms.
In some models, for example, an alarm that sounds distinctly different from 
the alarm that signals apnea sounds whenever the machine is turned off or 
unplugged without following a set procedure.

  a remote alarm unit.

The remote enables parents to leave the baby's room to carry on some of their 
usual activities. However, parents shouldn't get too far away, warns James J. 
McCue Jr., director of FDA's office of standards and regulations in the 
agency's Center for Devices and Radiological Health.

"Once the alarm goes off, you only have a short time to get back and get that 
child revived before there's a possibility of permanent brain damage," says 
McCue. "So you don't want parents out in the garden who won't be able to run
fast enough to get there in time."

False Alarms and Missed Alarms

Apnea monitors are not perfect. "Most apnea monitors will miss some apneas,"
says FDA in its February 1990 safety alert letter "Important Tips for Apnea 
Monitor Users." The agency adds that false alarms can't be completely avoided 
either. 

Probably the most common reason for a false alarm is shallow breathing, says
Rochester's Brooks. "The baby may be doing more abdominal breathing, so the 
chest wall where the electrodes are isn't moving enough to register," he
explains. 

Another common reason is loosened wires connecting the electrodes to the
monitor. This is a frequent problem because babies move around while they 
sleep.

FDA advises that parents be tolerant of false alarms and continue to use the
monitor as instructed. "The monitor can only do its job if it is turned on and
properly connected to your baby," according to the safety alert.

FDA warns, however, that while adjustments in the monitor or placement of the 
electrodes may help decrease the number of false alarms, parents shouldn't
make those adjustments themselves; that's a job for the health professionals
in charge of the baby's care. 

There are also situations in which the alarms might not go off even though the
baby has stopped breathing. For example, parents should not have the baby 
sleep in their bed because their movements might be picked up by the monitor. 
Other sources of interference with proper monitor function include: 

  electrical appliances such as electric blankets, electric water-bed heaters,
TV sets, air conditioners, and remote telephones. Keep these sources of 
interference at least a foot away from the monitor. 

  radio signals from police stations, fire stations, or airports. In some 
locations such interference may keep the monitor from working properly. 

Other tips from FDA's letter include: 

  Keep children and pets away from the monitor and the baby to prevent the
monitor from being accidentally disconnected. 

  Test the monitor before each use to ensure the alarm is working.

  Make sure the monitor's breath detection indicator light flashes only once
for each breath the baby takes while the baby is still. (The light may also 
flash when the baby moves.) If the baby is still and the light does not flash 
in unison with his or her breathing, contact your equipment provider
immediately.

  Make sure battery and charger connections are tight. If the monitor has a 
light that indicates when the battery is charging, it should not flicker when 
the connectors are gently wiggled or twisted. 

  Follow the manufacturer's recommendations and report problems to the monitor
provider or, if the provider can't help you, to the manufacturer. 

"It's important for parents to be as well acquainted with the monitor as they 
can be so they'll be able to detect problems right away," says Wally
Pellerite, a consumer safety officer with FDA's Center for Devices and
Radiological Health.

He says that there have been several recalls of apnea monitors over the last
three years due to problems in the design or production of the devices, and 
while it is the distributor's and manufacturer's responsibility to notify 
parents about defective monitors, "it's a good idea for parents to keep the 
lines of communication open" with the monitor provider. 

Memory Monitors 

There is no way to distinguish between false and real apnea episodes when the 
alarm first sounds. But even after the parents reach their baby's side, it may
not be clear what happened to set off the alarm.

Dorothy Bunn remembers bolting out of bed whenever her son Michael's monitor
alarm sounded. "My adrenaline would really be pumping," she said. Yet, as 
often as the alarm sounded--"one night it went off 17 times," she said--he was
always breathing when she reached his crib. 

"In some cases, the alarm itself will wake the baby up [and breathing will
start again]," says Meny. So, while the alarm may signal a true apnea episode,
parents have no way of knowing because the situation has resolved by the time 
they reach the crib.

Sometimes, upon hearing the alarm, parents run into the room and pick up the
baby without pausing to see if the baby has truly stopped breathing. This can 
make it hard to determine if it was really an instance of apnea. Although it
is recommended that parents turn on the light and look for signs of breathing 
before taking any action, it isn't easy for many parents to follow those
instructions, says Brooks.

"It's hard for parents to hear an alarm, be afraid their baby's dying, run
into the room, and before they touch the baby stand there and calmly assess 
everything," says Brooks. But whether the baby is truly not breathing or just 
taking shallow breaths, immediately picking the baby up frequently results in 
the baby taking a deep breath and waking up, and "we don't have a clue whether
that was a real alarm or not."

Though parents have no way of distinguishing a false alarm from a real one if 
the baby is breathing when they get there, some monitors are equipped to solve
the mystery after the event. Monitors with computer memories can store
information, such as the length of time the monitor didn't detect any 
breathing and what the heart rate was. (The proposed FDA standard does not
require a memory for minimum safety and effectiveness.) 

Other advantages of memory monitors include:

  detecting loose lead wires: Unlike a true problem, in which the heart rate
gradually drops, a loose lead wire will cause recorded heart rate to drop 
abruptly. 

  recording how much the heart rate dropped: "Say we set the monitor to alarm 
if the heart rate drops below 80 beats per minute," says Teri Reid, R.N., 
director of the apnea clinic at Children's Hospital in Washington, D.C. "But
how low did it go? Did it go to 75 or to 45? There's no way parents can know
that in the home. But we know when we get the printout [from the memory]. It
affects what kind of medical treatment we might give that baby."

  ensuring that parents use the machine: Memory monitors keep date and time 
records of when the machine is in use.

"I think memory is vital," says Meny. "I think every monitor that goes out on 
every baby in this country should have memory built into it, period." 

Brooks disagrees. "Memory isn't essential for every baby. It is, however, an
important tool when a baby has a lot of alarms that we just can't explain." 

Life with a Monitor 

"I have the feeling that in the beginning several parents not only did not
leave the monitor, but sat and watched it blink as well," writes Anne Barr in 
her booklet At Home With a Monitor, A Guide for Parents.

"It's very stressful," says Patricia Hughson, whose son Hassan was on a home
monitor until he was 8 months old. "You're anxious about using it. You don't
know what's going to happen." 

According to a report from the 1986 NIH Consensus Development Conference on 
Infantile Apnea and Home Monitoring, the parental stress comes not only from
the full-time responsibility of monitoring but also from assuming the 
responsibility for resuscitating a baby who stops breathing.

In addition, monitors invade every aspect of day-to-day life, says Brooks.
"Because they're afraid they'll miss an alarm, many parents won't take a
shower, go get the mail, or even turn on the TV in another room," says Brooks.

"There were times when it was definitely an inconvenience," Hughson says. "He 
slept in the room with us the first three months he was home, and if he moved 
the wrong way, it would go off. Of course, that would be at 2 a.m., and then
just as we would doze off, he'd wake up for a 2:30 or 3 a.m. feeding."

She adds, however, that having the monitor, overall, was wonderful because on 
three occasions Hassan, who was born almost three months prematurely, did stop
breathing.

While the stress of home monitoring is very real, it can be minimized if the
parents have support. "We make sure to train our parents in CPR," says Meny.
"We're also available to the parents 24 hours a day, seven days a week, and we
make sure that the vendors of the home monitors are also available around the 
clock." 

Parents of babies in the apnea clinic program at Children's Hospital in 
Washington, D.C., are assigned a visiting nurse. "The nurse goes to the house 
within 24 hours after the baby leaves the hospital," says Reid. "She reviews
how to use the monitor and checks the baby's room to make sure nothing like 
humidifiers will interfere with the monitor's operation." 

Reid has also set up a phone support program that puts parents in touch with
each other. "I tried to start a support group here at the hospital, but it was
too much trouble for the parents to get down here with their babies--and, of
course, the monitors--in tow. It's much easier for them to call each other
whenever they have a free moment."

Even the best of support programs cannot change the fact that monitor 
technology is still imperfect, and even when the monitor works as intended it 
can't save a baby's life. 

"Sometimes the alarms will go off, and the parents respond appropriately and
still the baby dies," says Brooks. "It's not 100 percent effective. It seems
like such a clear-cut way to prevent a baby's death, but it's nowhere near as 
clear-cut and straightforward as it seems at first blush."

Dori Stehlin is a staff writer for FDA Consumer magazine. 

Does Apnea Cause SIDS?

Talking about infant apnea without talking about sudden infant death syndrome 
is nearly impossible. But while apnea is of considerable interest to SIDS 
researchers, whether apnea causes SIDS is still unknown.

In the United States, between 5,000 and 7,000 infants die each year from SIDS,
making it the leading cause of death in children between the ages of 1 month
and 1 year, according to the U.S. Centers for Disease Control in Atlanta. The 
incidence of SIDS has remained fairly constant since it was first recognized
as a specific medical entity 20 years ago, even though infant mortality has 
been reduced overall. 

Infants thought to be at high risk for SIDS include:

  babies born prematurely 

  babies exposed before birth to drugs such as heroin or cocaine

  babies who survived an apparent life-threatening event

  twins of SIDS victims 

Whether subsequent siblings of SIDS victims are at increased risk is
controversial. "However, the anxiety of parents of siblings is often so 
intense that these babies are frequently treated as high-risk by the
clinician," says pediatrician Robert G. Meny, M.D., of the University of
Maryland. n 

--D.S.

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