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“A federal agency has found that a number of prestigious universities failed to tell more than a thousand families in a government-financed study of oxygen levels for extremely premature babies that the risks could include increased chances of blindness or death.
None of the families have yet been notified of the findings from the Office for Human Research Protections, which safeguards people who participate in government-financed research. But the agency’s conclusions were listed in great detail in a letter last month to the University of Alabama at Birmingham, the lead site in the study. In all, 23 academic institutions took part, including Stanford, Duke and Yale………….”
“Despite growing warnings from pediatricians about feeding newborns anything other than breast milk or formula, many mothers appear to be introducing solid food well before their babies’ bodies can handle it, says a study published Monday in the journal Pediatrics.
In a national survey of 1,334 mothers, conducted by the Centers for Disease Control and Prevention, 40 percent said they gave their baby solid food before they were 4 months old, with 9 percent starting as early as 4 weeks. Doctors now recommend waiting until a baby is at least 6 months old……………….”
Suffocation Deaths Associated with Use of Infant Sleep Positioners — United States, 1997–2011
November 23, 2012 / 61(46);933-937
Unintentional suffocation is the leading cause of injury death among children aged <1 year in the United States, accounting for nearly 1,000 infant deaths annually. Since 1984, an estimated fourfold increase has been observed in accidental suffocation and strangulation in bed, with many of these deaths linked to unsafe sleep environments (1,2). Infant sleep positioners (ISPs) are devices intended to keep an infant in a specific position while sleeping, yet ISPs have been reported to have been present in the sleep environment in some cases of unintentional infant suffocation (3,4) (Figure). Some specific ISPs have been cleared by the Food and Drug Administration (FDA) for the management of gastroesophageal reflux or plagiocephaly (asymmetry of the skull) (5). However, many unapproved ISPs have been marketed to the general public with claims of preventing sudden infant death syndrome (SIDS), improving health, and enhancing sleep comfort (5). To characterize infant deaths associated with ISPs, FDA, the U.S. Consumer Product Safety Commission (CPSC), and CDC examined information reported to CPSC about 13 infant deaths in the past 13 years associated with the use of ISPs. In this case series, all infants but one were aged ≤3 months, and most were placed on their sides to sleep. Many were found prone (i.e., lying on their abdomens). Accompanying medical issues included prematurity and intercurrent respiratory illnesses. When providing guidance for parents of newborns, health-care providers need to emphasize the importance of placing infants to sleep on their backs in a safe sleep environment. This includes reminders about the American Academy of Pediatrics (AAP) recommendations against side sleep position, ISPs and pillows, comforters, and other soft bedding.
A case was defined as an infant death reported to CPSC during January 1997–March 2011 that occurred in the presence of an ISP in the sleep environment. Thirteen cases were identified. Information was abstracted from a CPSC In-Depth Investigation file,* which included medical examiner and police reports made available to CPSC. This report describes the circumstances of one case and summarizes all 13 cases of infant death.
The male victim, aged 7 weeks, was one of twin infants born at 36 weeks’ gestation but otherwise was physically and developmentally normal. Five days before his death, he had a well-baby visit that revealed no health concerns. He slept in an ISP in a crib separate from his twin brother. The morning of his death, the victim was fed, uneventfully, at approximately 1:00 a.m. and was placed to sleep on his side in the ISP. At about 4:00 a.m., a care provider prepared the infants for their next feeding and discovered the victim in the ISP, unresponsive, with his face close to one of the ISP’s foam pads, which were used in conjunction with swaddling to keep a pacifier in the infant’s mouth. The autopsy report listed the cause of death as asphyxia by obstruction of the nose and mouth by a “foam positioning device.”
The ISP was a flat mat with side bolsters, which the mother purchased to prevent SIDS. The device was advertised as helping “position your baby while sleeping or resting” and instructions stated, “This product is to be used if your pediatrician has recommended side sleeping for your baby.”
Summary of 13 Cases
Among the 13 cases of infant death reported to CPSC in association with ISP use, the victims ranged in age from 21 days to 4 months (mean: 9.5 weeks, median: 3 months) (Table). Eight were male. Four victims had been born prematurely, and three of them were one of a pair of twins. One deceased twin had been diagnosed with bronchopulmonary dysplasia and gastroesophageal reflux. Of the 13 infants, four had recent respiratory symptoms and/or diagnoses of respiratory illness, including respiratory syncytial virus infection and colds.
Infants were most commonly placed on their sides to sleep (nine infants). One infant was placed prone. The position placement was not known for two cases; a discrepancy was noted between parental report and medical examiner assessment for the remaining case. Three families reported using the device in an effort to prevent SIDS. Other reported uses included preventing reflux (two cases), elevating the head (one case), preventing rolling over (three cases), and preventing plagiocephaly (one case). Instructions for use of involved ISPs were available for review for five cases; three indicated that side positioning an infant in the device was an acceptable use of the product. At least three cases involved ISPs with cautionary labeling “once your baby begins to move around during sleep, the sleep positioner should no longer be used.”
This case series summarizes characteristics of the 13 infant suffocation deaths related to ISP use reported to CPSC during January 1997–March 2011. In these cases, ISPs often were used to position infants on their sides. At least nine of the infants were placed on their sides (and one prone), raising the concern that the “back-to-sleep” message to position infants on their backs is either not being heard or not being followed. CDC data from the Pregnancy Risk Assessment Monitoring System CPONDER web-based query system provides an indicator of whether infants most often are positioned on their backs for sleep. Data from reporting states in 2008 suggest that approximately 25% of infants are not being placed supine for sleep (6).
Some infants are at increased risk for SIDS; risk factors include premature birth, twin birth, and male gender (7). This case series raises concerns about ISPs contributing to the risk for suffocation, in the absence of any evidence that ISPs are effective in reducing the risk for SIDS.
Although ISPs have been available since the 1980s, only a few ISP manufacturers have been cleared by the FDA to provide products, by prescription, to manage particular medical conditions (e.g., gastroesophageal reflux). Despite other manufacturers’ claims regarding SIDS prevention or other health benefits, FDA has never cleared or approved an ISP for preventing or reducing the risk for SIDS. Cleared ISPs should only be used by prescription for treatment of specific medical conditions.
After reports of infant suffocation related to ISP use in 2010, CPSC and the FDA launched a joint effort; on September 29, 2010, FDA and CPSC released statements concerning the danger associated with the use of ISPs (5,8). The agencies urged families to discontinue use of unapproved ISPs, through media messages indicating that “back-to-sleep” is best and ISPs are not necessary to keep infants on their backs (5,8). In addition, they advised health-care providers to continue counseling families on safe sleep practices in accordance with AAP’s recommendations (7). FDA has contacted all manufacturers requesting that all sales be halted until companies submit safety and effectiveness data that not only support the medical claims of their devices but also demonstrate that benefits from use of the product outweigh the risks for suffocation (3).
An additional concern is the “hand-me-down” availability of ISPs. Many products for children, some of which might have been recalled, are passed along by family and friends or purchased from second-hand stores. Public health education and health-care provider counseling are important ways to reduce the inappropriate use of ISPs.
In 2005, AAP definitively recommended against side positioning (9). In 2011, AAP released a comprehensive policy statement on safe sleep environments for infants to reduce the risk for SIDS and suffocation (7). FDA and CPSC also have issued recommendations consistent with the current AAP statements concerning ISPs. First, parents and caregivers should stop using ISPs unless specifically prescribed by their pediatricians. Supine sleeping is safest; use of a device is not necessary in this position and is potentially hazardous. Second, they should never put pillows, comforters, or unprescribed ISPs in an infant’s sleep environment. Finally, they should place infants to sleep on their backs.
The findings in this report are subject to at least five limitations. First, as with many case series, the total number of cases is unknown because the data are from voluntary reporting. Second, because the number of ISPs in use is not known, the risk for suffocation when an ISP is present cannot be directly compared with the risk when no ISP is present. Third, only information on deaths was collected; nonfatal cases are not reported. Fourth, variability was observed in the type and detail of information in each report because no standardized system is implemented consistently. For example, one report used the more recently available Sudden Unexplained Infant Death Investigation reporting form.† Finally, this series includes cases reported during 1997–2011; products, instructions, and even recommendations have changed over this 13-year period, which might have influenced use of these devices and reporting of cases.
The need for a safe sleep environment for infants (i.e., in a crib, on their backs [not their sides], without soft objects, loose bedding, or an ISP) is still an important public health message. The original Back-to-Sleep campaign (launched in 1994 by the National Institute of Child Health and Human Development, the U.S. Department of Health and Human Services Child Care Bureau and Maternal and Child Health Bureau, and AAP) did not preclude side sleeping; consequently, manufacturers developed ISPs to keep babies in specific positions. However, ISPs are not necessary to keep a baby supine, and other positions increase the risk for SIDS and/or suffocation. Although some ISPs contained cautionary statements like “discontinue use once baby begins to move around,” these statements are unclear, and caregivers cannot accurately predict when an infant will achieve milestones. Clear, consistent, and frequent reinforcement of the safe sleep messages by public health practitioners and health-care providers is needed to prevent further infant suffocations.
Additional information is available online from FDA at http://www.fda.gov/forconsumers/consumerupdates/ucm227575.htm, from CPSC at http://www.cpsc.gov/cpscpub/prerel/prhtml10/10358.html, and from CDC at http://www.cdc.gov/sids.
Michelle Gillice, JD. John Topping, Div of Hazard Analysis, Directorate for Epidemiology, Jonathan Midgett, PhD, Div of Human Factors, Consumer Product Safety Commission.
* Contains data from investigations on death or injury associated with a particular consumer product.
† Additional information available at http://www.cdc.gov/sids/suidrf.htm#1.
What is already known on this topic?
Infant suffocation is a common cause of infant death and often is associated with the sleep environment. The safest sleep environment for infants is in a crib, on their backs (not their sides), without soft objects, loose bedding, or an infant sleep positioner (ISP).
What is added by this report?
Thirteen cases of infant deaths that occurred in the presence of an ISP in the sleep environment were reported to the U.S. Consumer Product Safety Commission during January 1997–March 2011. In this case series, all but one infant were aged ≤3 months, and most were placed on their sides to sleep.
What are the implications for public health practice?
Parents should continue to be made aware of what is the safest sleep environment for infants and reminded that commercial devices are not necessary to keep infants on their backs to sleep.
|TABLE. Unexplained infant deaths associated with infant sleep positioners, by selected characteristics — United States, 1997–2011|
|Year||Age||Sex||Race (ethnicity, if noted)||Positioner type||Reported use or Advertised use*||Placement position||Position when found||Medical issues||Comments|
|1997||2 mos||Male||Unknown||Flat mat with bolsters||“to prevent SIDS by placing infant on side when sleeping”||Side||Prone; after rolling forward, arm trapped between body and wedge||NA||NA|
|1998||2 mos||Female||White||Flat mat with bolsters||“helps keep sleeping infant on its back” with side position diagram and instructions||Supine||Prone with face in pillow part of positioner||NA||Similar device used with older sibling|
|1999||4 mos||Female||White||Incline with harness (12 in. incline)||“maintain them in semi-upright position” and “to reduce the incidence of SIDS”||Unknown||Prone; out of harness lying on crib mattress||30 wks gestation; twin; diagnosed with bronchopulmonary dysplasia (on no active medical therapy); gastroesophageal reflux disease||NA|
|2002||7 wks||Male||White||Flat mat with bolsters||“helps position baby while sleeping or resting” with side position diagram and instructions||Side||On side between bolsters; face close to bolsters||36 wks gestation, twin||Foam pad of device was used to brace pacifier|
|2004||15 wks||Female||White||Flat mat with bolsters||“to prop baby on left side”||Side||Prone||NA||NA|
|2006||3 mos||Male||White (Hispanic)||Flat mat with bolsters||“lets baby sleep safer and cooler” with “Side Sleeping Position: (Alternative)” instructions||Unknown||Supine||Recent upper respiratory infection; taking prescribed medication||NA|
|2006||3 mos||Male||White||Inclined with wedges||“Designed to prevent flat head syndrome and common acid reflux”||Side||Prone||Constipation during 24 hrs prior, vomited once 1–2 hours before bedtime||NA|
|2008||3 mos||Male||Black||Inclined with bolsters||“elevate head”||Side||Prone; head entrapped between positioner and bassinet||6 wks premature||NA|
|2009||1 mos||Female||Black||Flat mat with bolsters||“Recommended for use in positioning baby to help reduce the risk of SIDS.”||Side||Prone; head on layers of added soft bedding||NA||NA|
|2009||3 mos||Male||White||Flat mat with pillow attached and side bolsters||“to keep him from rolling over”||Prone||Prone; face in pillow part of positioner||Cold 3 wks prior||NA|
|2010||7 wks||Male||White||Inclined with wedges||“to prevent the baby from getting a flat head … and prevent him from rolling over”||Side||Prone; wedged between sleep positioner and crib bumper||Recent viral illness; respiratory symptoms, vomiting, and treatment with antibiotic||Similar device used with an older sibling|
|2010||3 mos||Male||White||Contains two bolsters; unknown if flat mat or inclined||Not reported||Side||Prone; wrapped in swaddling blanket with arms inside between two bolsters||36 wks gestation; twin; diagnosed 6 wks prior with respiratory syncytial virus||NA|
|2010||21 days||Female||Black||Inclined with bolsters||“elevates baby’s head to help ease breathing and enhance digestion” and “eliminate over-heating”||Side||Prone||NA||NA|
|Abbreviations:SIDS = sudden infant death syndrome; NA = not applicable or not available.* Reported use includes information reported by parents on why they were using the device. In the absence of parental report, advertised use (in italics) is provided from the available product packaging or advertisement claim by manufacturer.|
Van 23 niños muertos durante el año
Altamente contagiosa: Alerta en Bogotá por rebrote de Tos ferina
Bogotá, noviembre 7 – “La tos ferina, una enfermedad infecciosa y altamente contagiosa que se puede prevenir en los niños con la vacunación, resurgió en Bogotá y este año ha causado ya la muerte de 23 menores de 5 años……”
Por: Agencias |
June 6, 2012, 6:30 pm
“CT scans in children can cause small but significant increases in the risk of leukemia and brain cancer, a new study finds.
Researchers say the results do not mean that CT scans should be avoided entirely — they can be vitally important in certain situations, like diagnosing severe head injuries — but that the test should be performed only when necessary, and with the lowest possible dose of radiation…….. Concern about potential harm from the scans has grown as their use has climbed steeply; at least four million children a year receive scans in the United States, and researchers estimate that a third of the scans are unnecessary or could be replaced by safer tests like ultrasound or magnetic resonance imaging, which do not use radiation.
The new study, published online on Wednesday in The Lancet……is based on the records of nearly 180,000 children who had scans from 1985 to 2002 in Britain. There were 74 cases of leukemia and 135 cases of brain cancer in the group. The authors estimated the radiation doses and found that the more scans the children had and the more radiation they received, the higher their risk. Children under 15 who had two or three scans of the head had triple the risk of brain cancer compared with the general population….and 5 to 10 scans tripled the risk of leukemia. But the baseline risk is extremely low — 4.5 cases of leukemia per 100,000 people under 20, and 3.5 cases of cancer of the brain or central nervous system — so that even tripled, it remains small……”
Mumps outbreak infected 11 at city school
By: Nick Martin
Posted: 04/21/2012 1:00 AM
Winnepeg Free Press
“EIGHT students and three adults at one Winnipeg school contracted mumps in an unusual outbreak this winter that resulted in more than 200 people being immunized.
The Winnipeg Regional Health Authority is using the outbreak to draw attention to Immunization Awareness Week next week…..”
Leroy Z, Broder K, Menschik D, et al. Febrile seizures after 2010-11 influenza vaccine in young children, United States: a vaccine safety signal from the Vaccine Adverse Event Reporting System. Vaccine 2012 Mar;30(11):2020-23 [Abstract]
During the 2010–2011 influenza season…..[CDC] conducted enhanced vaccine safety monitoring for possible febrile seizures in all trivalent influenza vaccine (TIV) products in the United States using the Vaccine Adverse Event Reporting System (VAERS)…….. On November 23, 2010, the combination of the coding term “febrile convulsion” and the Fluzone® TIV product exceeded a predetermined threshold in the VAERS database. By December 10, we confirmed 43 reports of febrile seizure following TIV in children aged 6–23 months. Clinical features of most reports were consistent with typical uncomplicated febrile seizures, and all children recovered….”