November 7, 2014

Don’t Let Babies Sleep on Couches

A recent study confirms that babies who sleep or nap on soft surfaces, like sofas, are at risk of dying.

According to the research published in Pediatrics, about 1 in 8 cases of so-called “crib death,” occurs among infants who have been placed on sofas. Crib death, also known as sudden infant death syndrome (SIDS), is the unexplained death, usually during sleep, of an otherwise healthy baby younger than 1 year.

Earlier research, according to the New York Times, showed that couches were hazardous for infants, and the new research set out to pin down all the factors contributing to these deaths.

Researchers analyzed data on 7,934 sudden infant deaths in 24 states. They compared those that occurred on sofas with those in cribs, bassinets or beds. Almost 3 in 4 deaths occurred among infants 3 months or younger.

Most parents in the study shared the sofa with the baby they placed there. But researchers said it was a mistake to believe that if you’re awake or watching the child, he or she is not at risk of SIDS.

Sleep-deprived parents, the thinking goes, are more likely to fall asleep on the couch next to their newborns. The design of the furniture can be a problem, too — some sofas slope toward the back cushions, and infants get wedged into a position where they can’t breathe.

Dr. Barbara Ostfeld, program director of the SIDS Center of New Jersey, told The Times, “Many parents think for safety, ‘I’ll put the baby between myself and the back of the sofa.'” But, “the unplanned and unexpected happens. The grief is beyond painful and endures for a lifetime.”

The lead researcher said that infants “need to sleep alone, on their backs and in a crib, and it doesn’t matter if it’s for a nap or overnight. And it doesn’t matter if the parent is awake or asleep.”

The New York Times has assembled a resource for SIDS information. See our blog about the Consumer Product Safety Commission and crib safety here.

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September 27, 2013

How Big Pharma and the Feds Caused Infant Deaths Over Confusing Acetaminophen Dosages

For 15 years, McNeil Consumer Healthcare, a division of Johnson & Johnson, had sold two versions of Tylenol for young children even though the company knew that parents and doctors were confusing the two. They knew that confusion could have serious, even deadly, results. The FDA ignored the problem.

We’ve addressed the problem with dosing with acetaminophen, the active ingredient in Tylenol, and now a shocking story by the investigative news site ProPublica.org probes even deeper into the confusion over the two types of pediatric Tylenol, and why that’s so dangerous. Remarkably, the story says, “Drop for drop, the strength of Infants’ Tylenol far exceeded that of Children’s Tylenol.

“In addition, the active ingredient in Tylenol, acetaminophen, has what the FDA deems a narrow margin of safety. The drug is generally safe at recommended doses, but the difference between the dose that helps and the dose that can cause serious harm is one of the smallest for any over-the-counter drug.”

Other manufacturers’ products compounded the problem by also offering two children’s products with different concentrations of acetaminophen. Between 2000 and 2009, 20 reports of children who died from acetaminophen toxicity were filed with the FDA, which acknowledged that the figure probably “significantly underestimates” the true incidence.

Between 2001 and 2010, according to the American Association of Poison Control Centers, about twice as many deaths each year were associated with acetaminophen than with all other over-the-counter pain relievers combined, according to data from. Tens of thousands more are hospitalized for overdoses.

ProPublica tells the heartbreaking stories of babies who suffered unnecessarily. To see how the intersection of federal regulatory sloth and pharmaceutical company misbehavior conspired to harm and sometimes kill people seeking only to relieve pain, see our blog, “Acetaminophen Continues to Rack Up Casualties and Escape Regulatory Control.”

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October 27, 2011

Stripping Down the Crib to Cut the Risk of Sudden Infant Death

When it comes to babies and sleep, the American Academy of Pediatrics (AAP) has made it official: Less is more.

Its new guidelines call for cribs empty of everything except the baby and the tightly sheeted mattress. No blankets. No bumpers, pillows or toys. They’re all hazardous for babies because they present a risk of suffocation, entrapment and asphyxia.

In a report for NPR, pediatrician Rachel Moon, chairwoman of the AAP Task Force on Sudden Infant Death Syndrome (SIDS), said, "Babies can roll into [anything] soft and suffocate against it, and babies can crawl under it and suffocate. Even the hard bumper pads are a problem because babies can scoot in and get their head wedged in between the mattress and the bumper pad and can't get out."

In the last two decades, the incidence of SIDS has fallen dramatically, thanks to the academy’s evolving understanding of the syndrome. All parents now are schooled in the "Back to Sleep" idea: Put your baby to sleep on her back, not her stomach; the admonition to keep cribs clear is another effort to address SIDS, which still causes about 2,300 babies to die every year in the U.S.

Some products claim they can help prevent SIDS, but that’s bogus. In fact, the FDA has issued a consumer alert about such claims.

The only proven methods to reduce the chances of SIDS are proper sleeping posture and clear cribs. In addition, the academy recommends that cribs be located in the parents’ room -- but babies should not sleep in the same bed – and that babies be breast fed and immunized to prevent infant death. The latter two help prevent infection, which often precedes an incident of SIDS.

Other habits pregnant women indulge that appear to increase the risks are smoking, drinking alcohol and taking illicit drugs.

Still, accidental suffocation may account for some SIDS casualties, and some babies are particularly vulnerable because their brains haven’t fully matured and they don't wake up easily when faced with an obstacle.

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August 21, 2011

Learning from Tragedy: The Faces of Children Hurt by Medical Error

The Empowered Patient Coalition has put together a moving short video of some of the many children killed from malpractice and other medical errors. Watch it here.

Then check out the Coalition's website for tools on how you can be a safer, smarter patient for yourself and your loved ones.

Helen Haskell and Dr. Julia Hallisy are mothers of children harmed by medical error who founded the Empowered Patient Coalition to try to make the medical system better and safer for future patients.

Another touching video on turning medical tragedy into something positive was put together recently by Mary Ellen Mannix, a mom who lost a baby to medical mistakes in 2001. She went on to start James's Project, which focuses on patient safety to improve infant mortality and maternal health. Watch the video here.

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February 18, 2011

Fetal heart rate monitoring significantly cuts baby deaths

The use of fetal heart rate monitors lowers the rate of infant mortality, according to a new study. Previous studies were too small to definitively prove the effectiveness of fetal monitoring, and some obstetricians maintained that the technology had been adopted too quickly.

But the new study, which was presented at the Society for Maternal-Fetal Medicine's (SMFM) annual meeting in San Francisco, used data from the 2004 National Birth Cohort to get a large enough sample (1,945,789 singleton births that met the studies inclusion criteria) to gauge its effectiveness.

The study found that in 2004, 88% of singleton pregnancies had fetal heart-rate monitoring and associated the monitoring with significantly lower infant mortality (3.8 per thousand live births without monitoring vs. 3.0 with monitoring), which in turn was mainly driven by a 53% decrease in early neonatal mortality. The decreased risk was associated with both low- and high-risk pregnancies.

Source: Science Daily

You’ll find an abstract of the study here.

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February 9, 2011

Governments plan to make polio a disease of the past

Two U.S. government agencies - the Centers for Disease Control and Prevention (CDC) and the the U.S. Agency for International Development (USAID) - joined the World Health Organization WHO) and the Russian Ministry of Health and Social Development to sign the global protocol of intent to eradicate polio wherever it occurs. The agreement also has the support of international charity organizations, such as Rotary International, and will reach out to communities throughout the world.

Polio has long been eradicated in North America due to successful vaccination programs, but outbreaks of this highly infectious crippling disease continue to occur in some central Asian and African countries. And because polio is extremely contagious, there is always a risk of it being transmitted to countries where it no longer exists or was thought to be eradicated, including the U.S. Since this poses a risk to unvaccinated children, the goal of the agreement is to eradicate all strains of polio.

Since 2006, only four countries - Afghanistan, India, Nigeria and Pakistan - remain polio-endemic with indigenous poliovirus circulation. Additionally, in four African countries wild poliovirus was either known (Angola, Chad) or suspected (Democratic Republic of the Congo, southern Sudan) to have persisted for for more than 12 months as of mid-2009, leading to their designation as having “re-established” transmission.

Unfortunately, the list does not end there, as the following countries have had imported polio cases or cases related to an imported poliovirus within the past 24 months: Angola, Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Côte d'Ivoire, the Democratic Republic of the Congo (DRC), Ghana, Guinea, Kazakhstan, Kenya, Liberia, Mali, Mauritania, Nepal, Niger, Russia, Senegal, Sierra Leone, Sudan, Tajikistan, Togo, Turkmenistan and Uganda.

Source: USAID

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August 1, 2010

Protecting Babies from Hospital Malpractice in Labor and Delivery Units

Who's at fault for the high rate of Cesarean sections in the United States? If you listen to the obstetricians, it's all about lawsuits -- they are at risk of being sued for "anything short of a perfect outcome," as two doctors wrote last week in a letter to the editor in the New York Times.

But maybe the real issue is basic patient safety, and the failure of hospitals and doctors to have the right staffing necessary to make vaginal childbirth safe after a previous C-section.

If you listen to the euphemisms from the medical industry, "less than perfect outcome" sounds like parents suing over a small blemish or other trivial injury. What is really at stake, however, is permanent devastating brain injury caused by a hospital not having the resources to deliver a baby quickly enough when the vaginal birth attempt has gone south.

Three in ten American women now deliver their babies by Cesarean section, which seems like a lot. And many of those are repeat Cesareans which only happen because of the prior Cesarean, even if it might be safe to at least try normal labor and see if the baby can be delivered safely. Recent headlines suggested that hospitals were refusing to even let women try a course of normal labor after a prior Cesarean. They couldn't afford the lawsuits, it was suggested.

But here's the problem with VBAC -- vaginal birth after Cesarean. In one in 100 to one in 200 VBAC attempts, the uterus ruptures. This cuts off the baby's lifeline. The best studies show that brain damage begins in around 17 to 18 minutes, and worsens dramatically every minute after that the baby remains undelivered. After 30 minutes, most babies in ruptured uteruses are dead if not delivered.

New guidelines from the American College of Obstetricians and Gynecologists (ACOG) for VBAC have stuck to the group's 1999 recommendation that a surgical team has to be "immediately available" to deliver the baby by C-section in the event of a rupture. Immediate means right there in the hospital, ready to operate.

Hospitals don't like the "immediately available" standard, and prefer the old, looser guideline of "readily available," whatever that means. After the 1999 guidance of "immediately available" was issued, a number of hospitals, rather than having the right staffing level to ensure baby safety, simply banned VBAC procedures and said any pregnant woman with a prior C-section had to have another C-section in their hospital. This conjures up an image of tying women to hospital beds and hovering over them with scalpels, so that doesn't sound right either.

In March 2010, the National Institutes of Health convened a panel of experts who took a step backward by asking the obstetricians to consider softening the guidance back to the old "readily available" or some other mushy language.

Thankfully, ACOG didn't do that. But -- and this is a big but -- the obstetricians are now talking about pushing the risk of brain damage back onto the parents -- without giving them the full picture to make an intelligent decision.

As quoted in the New York Times, the new ACOG guideline adds the recommendation that if an immediate Caesarean is not available, it should be explained to the patient, and she should be "allowed to accept increased levels of risk." And Dr. Richard Waldman, president of the obstetricians' group, said: "What I'm hoping is that everybody will get together and do the right thing. That includes patients. If they take the risk, they have a certain responsibility not to sue the physician if there's a bad outcome, knowing that they took the risk."

You can search ACOG's statement about its new guidelines high and low, and you will never find the key facts spelled out about what this risk really means -- a child who can never walk, talk or have normal development.

ACOG and the hospitals seem more focused on the risk of lawsuits than the risk of catastrophically injured babies. It would be like talking about the danger of oil spills from deepwater drilling based on how many lawsuits would happen, not on how much damage to the environment would result.

Let's make sure our communications are very clear. We're talking about delivering babies safely. The lawsuit buzz is just a convenient whipping boy for those who want to avoid tough questions about why they're not investing in safe childbirth facilities for mothers and families.


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July 24, 2010

Getting the Word Out on Dangerous Kids' Products

Many kids' products -- cribs, high chairs, strollers and more -- last for years and years, which can be a tragic problem if the product turns out to have a hidden danger that only becomes obvious long after purchase. Now there's a law intended to deal with the issue.

As of this summer, manufacturers of children's products have to comply with new safety requirements per the “Danny Keysar Child Product Safety Notification Act,” named after a child who was strangled to death in a defective crib. The act requires manufacturers of children products to “establish and maintain a registration card program,” reports Lisa Parker of NBC Chicago. The registration cards will be included with the product and the program will keep records for at least 6 years of consumers who do register. This will facilitate notification of any recalls or safety concerns regarding the product.

The act, which took effect on June 28, 2010, affects the following product categories, according to Parker: Full-size and other cribs, Toddler beds, High chairs, Booster chairs, Hook-on chairs, Bath seats, Gates, Play yards, Stationary activity centers, Infant carriers, Strollers, Walkers, Swings, Bassinets, Cradles, Children’s folding chairs, Changing tables, Infant bouncers, Infant bathtubs, Portable toddler bed rails, and Infant slings.

An announcement of the act going into effect can be found on the Kids In Danger website.

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July 23, 2010

Higher Risk of Death for Babies Born at Night?

There might be a greater risk for medical malpractice in childbirth when babies are born at night, a provocative but inconclusive study suggests.

In a study published in British Medical Journal’s July 2010 issue, researchers from University of Cambridge and University of Glasgow report a slightly higher mortality rate of babies born outside of normal working hours, according to NHS News of the U.K.

The study analyzes Scotland’s records of more than one million full-term, single baby births from 1985 to 2004. After adjusting several factors (e.g. socioeconomic and maternal age, among others), the researchers find that babies born over weekends or overnight during weekdays are three times more likely to die of lack of oxygen than those born during normal working hours. However, the mortality rates in both groups are still very low: the mortality rate of those born during normal working hours is 4.2 out of 10,000 births; and that of babies born outside of the “safer” hours is 5.6 out of 10,000.

Authors of the study did not explore causes of the higher mortality rate for births outside of normal working hours, but cited fatigue and shortage of hospital staff as some of the possibilities. The BMJ article can be found here.

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June 14, 2010

Muscle Spasms: Uncommon but Dangerous Condition in Infants

Infantile spasm is an uncommon condition in babies between 4 to 8 months that, if untreated, can lead to irreversible brain damage. Babies suffering from the condition stop developing and can even regress. They can lose abilities to sit, babble or roll over. Although infantile spasm is a serious condition, it is often misdiagnosed as gas or colic because its symptoms mimic these other less serious problems.

Infantile spasm (IS) presents itself in the form of muscle contractions. Different from other conditions, IS occurs in clusters: “Babies can have clusters of 100 spasms or more at a time, dozens of times a day,” according to Jeanne Milsap in her article for Sun-Times Media. Milsap describes the spasms as “a sudden bending forward of the body with stiffening of the arms and legs. Some babies arch their backs. Most typical are little flexion jerks similar to the startle reflex.”

IS can be diagnosed simply with an EEG that would show chaotic brain waves. It is treated with anti-convulsants, hormonal injections, diet change, or surgery in more serious cases.

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June 3, 2010

Watch Out for Button Batteries and Kids

Tiny lithium batteries the size and shape of buttons can kill or cause severe injury in a child who swallows one, doctors are reporting.

The batteries, which are found in remote controls, watches, and other home electronics and toys, cause a chemical reaction when swallowed that can burn through the delicate tissues in the neck. Kids sometimes swallow them when they take apart a toy, find the battery, and think it's candy.

While rare, a death was reported in one child where the battery burned through the esophagus and attacked the aorta. Another child was left with a lifelong whisper from vocal cord damage. Another had to have feeding tubes and multiple surgeries for the damage to the gastric tract.

The journal Pediatrics reports the dangers of ingestion of lithium batteries by infants, which can and has caused deaths, writes Tara Parker-Pope of the New York Times.

The lead author of the medical journal article on this subject, Dr. Litovitz, says there is a “tight timeline” in which to rescue children from the injuries caused by lithium ingestion: while the batteries start causing severe damages as quickly as within 2 hours of ingestion, the problem is difficult to be diagnosed because small children cannot verbally communicate, and their symptoms (which can be loss of appetite, vomiting, coughing up blood) are nonspecific.

Pediatricians and parents are working to raise awareness of the dangers of small lithium batteries and to urge manufacturers of electronics to secure the battery in all electronic devices, not just toys. A woman whose 18-month-old daughter died after ingesting a lithium battery said that “there should be warnings on every item the batteries are in. They are in greeting cards and children’s books that talk. They’re everywhere.”

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June 1, 2010

Warning Labels Urged on Foods that Can Choke Children

Popcorn and hot dogs can pose a deadly choking hazard for children under four, and the risk isn't lowered by parents monitoring their kids' eating of these foods, says the official group representing American pediatricians. So experts are saying the best thing is to avoid risky foods before age four. According to the American Academy of Pediatrics’ policy statement on the prevention of choking among children, choking is a leading cause of death in children and is most frequently caused by food, coins and toys. However, unlike with toys, there are not yet requirements for warning labels on foods that present choking hazards. The Academy’s new policy statement urges the Food and Drug Administration to impose safety requirements on foods that are known to be choking hazards, Laurie Tarkan reports in a New York Times article. In addition to putting warning labels on food packaging, the Academy also suggests that manufacturers redesign the foods to reduce dangers of children choking on them. Toddlers, especially those under 4 whose throat at its narrowest has the diameter of a straw, easily choke on small pieces of foods, among which popcorn and hot dogs are considered high-risk foods. The risk is not reduced by parents being present and watching when children ingest these foods. “The only way” to prevent kids choking on small objects and food is to keep the items out of their mouth, according to Chrissy Cianflone, director of programs for Safe Kids USA, an advocacy group. Currently, only two-thirds of hot dogs have warning labels on the packages, says the National Hot Dog and Sausage Council. And even on the packages that do carry warning messages, the labels are not always obvious to consumers. The FDA in a statement indicates that “it was reviewing the pediatrics academy’s new policy and was considering steps to prevent further deaths,” according to the NY Times story. Dr. Gary Smith, director of the Center for Injury Research and Policy at Nationwide Children’s Hospital in Ohio, suggests that parents wait till children turn 4 or 5 years of age to allow them to eat high-risk foods such as popcorn, hot dogs, and grapes.

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December 10, 2009

Infant Deaths Prompt Baby Hammock Recalls

This week the Consumer Product Safety Commission announced a voluntary recall of 24,000 motion beds for babies, writes Jennifer Kerr of the Associated Press. Manufactured by Amby Baby of USA and sold online through its website since 2003, Amby Baby Motion Beds consist of a steel frame and a fabric hammock that has mesh sides and hangs from a spring. The bed gently swings as the baby moves, a feature designed to resemble babies’ motion in the maternal womb.

Although many babies have found comfort in these hammock beds, there is a hidden risk of suffocation: as the bed moves back and forth, babies could roll and become trapped or wedged against the fabric or the mattress pad. In fact, as Jennifer Kerr reports, two infant deaths in the United States have been associated with Amby Baby Motion Beds, which prompted the CPSC’s recall of the product.

In her story, Jennifer Kerr quotes Nancy Cowles, executive director of Kids In Danger, “There is currently no safety standards that would cover hammocks.” Kerr says that safety advocates maintain that it’s safest for babies to be “in cribs or bassinets with a firm bottom support and no soft bedding, gaps or other points where they could become trapped.”

The CPSC urges parents to immediately stop using the hammock beds for the safety of their babies.

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December 4, 2009

Are Your Children's Toys Safe?

According to a Consumer Product Safety Commission (CPSC) report, in 2007, there were 22 toy-related deaths in the United States, and in 2008 there were 19. That translates to at least one death every month in from dangerous toys – toys that should provide enjoyment but instead have hidden death traps.

The causes of deaths include, among others, airway obstruction, strangulation, and blunt force. Dangerous toys also account for other serious injuries like laceration and burns, as well as more than 170,000 emergency room visits annually for injuries to children 15 years or younger, according to Don Keenan, Atlanta attorney and child advocate.

Don Keenan has put together a list of Top 10 Dangerous Toys for 2009, available on his website, Keenan’s Kids Foundation. He also has a link to CPSC’s list of recalled toys.

Notably, in Don Keenan’s introduction to the Top 10 Dangerous Toys list, he cautions consumers that many of these dangerous toys, although banned or recalled by the CPSC, still made their way onto the shelves in stores like Target or Walmart. The recalled toys are also easily available on the Internet at sites like eBay or in used toy stores. Other toys that were not recalled also may not be completely safe – in February 2009, the government enacted stringent standards, but Keenan’s Kids Foundation estimates that as many as 5% of toys currently on the market probably do not meet the new safety standards (such as requiring all children products to be tested by a third-party lab to ensure they meet safety standards, and banning the use of phthalates, a plastic softener, or products that contain trace amounts of lead).

Therefore, in this holiday gift-buying season, parents are urged to use extra caution in selecting safe toys, by carefully reading the safety warning label to see if the toy is age-appropriate for your children, and comparing against the CPSC’s recall list.

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May 13, 2009

Third Jardine Crib Recall in a Year

On May 1, 2009, the U.S. Consumer Product Safety Commission announced another recall of cribs made by Jardine Enterprises, the third safety recall since June 2008, reports Patricia Callahan of the Chicago Tribune. All three recalls involved cribs made in China and Vietnam.

The Jardine cribs in the recalls, mostly sold at Toys R Us and Babies R Us, are responsible for more than 30 reports of broken slats, one of the deadliest hazards of baby cribs. When a slat breaks, babies’ bodies slip through the gaps but their heads get stuck, resulting in strangulation and even death.

Parents can access a full list of recalled models at www.cpsc.gov. For those who bought one of the recalled cribs, a credit is available toward the purchase of a replacement.

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May 4, 2009

Infant Car Seats Failed Safety Standard Tests

The Chicago Tribune uncovered federal safety test results of infant car seats that were never publicized or even made known to some of the infant-seat manufacturers, reported Chicago Tribune’s Patricia Callahan. In the frontal crash tests, a video showed the car seats flying off their bases, throwing baby dummies face-first into the back of the driver’s seat. The test reports also documented that almost half of the 66 seats that were tested in front crashes “either separated from their bases or exceeded injury limits.”

As a result of the Chicago Tribune’s investigations, the National Highway Traffic Safety Administration has ordered a thorough review of safety regulations for car seats and taken steps to make the safety test results more available to consumers. Before, parents could compare safety ratings for cars, but would have no way of comparing which car seats do better at protecting their babies. They would not have known that more expensive car seats are not necessarily safer, or that some smaller cars performed better than the larger ones in these collision tests.

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August 16, 2008

Highway Proximity and Infant Health

A recent Canadian study shows that pregnant women who live near highways are more likely to give birth to premature or low-birth-weight infants--but only among wealthy mothers. Pollution from the highways is what causes these effects, researchers say. The reason why these results are not found among poorer mothers is, says lead researcher Dr. Melissa Generoux, because poorer mothers have so many more risk factors that this particular single factor has less of an obvious effect. Wealthier mothers, safe from other risks, are more likely to be noticeably affected by this one factor.

Expecting mothers are bombarded with advice and even lectures on the minutest details of what they consume during pregnancy, and are often overcome with anxiety over these matters. Yet they and their children are still powerfully affected by factors outside their personal control, such as the level of pollution near residential areas.

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March 27, 2008

Anne Arundel County Infant Mortality Reduction Program at Risk

The Healthy Start Program for reduction of infant mortality in Anne Arundel County, Maryland is at risk after its recent loss of $610,000 in federal funding.

From the article:

The black infant mortality rate became a "widespread concern" for the county five years ago, when data indicated that the rate increased to 23 infant deaths for every 1,000 live births, the Capital reports. Currently, the infant mortality rate for blacks in Anne Arundel County is four times higher than that of whites, and 21 black infants in the county die before age one for every 1,000 live births, a rate three times higher than the national average.

County Health Officer Frances Phillips hopes to "cobble together a diminished Healthy Start program," but nurses would be unable to complete the 500 home visits or address the 3,000 in annual referrals as they did before, according to the Capital. If county or state funds are not made available for the program, it "would be catastrophic" for the health department, Phillips said, adding, "There is no fat. There is no ability to shave [that much money]."

The loss of funding for this program threatens to have a serious effect on the infant mortality rate in Anne Arundel County.

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