Xylitol syrup for the prevention of acute otitis media.

BACKGROUND: Acute otitis media (AOM) is a common childhood illness and the leading indication for antibiotic prescriptions for US children. Xylitol, a naturally occurring sugar alcohol, can reduce AOM when given 5 times per day as a gum or syrup, but a more convenient dosing regimen is needed for widespread adoption. METHODS: We designed a pragmatic practice-based randomized controlled trial to determine if viscous xylitol solution at a dose of 5 g 3 times per day could reduce the occurrence of clinically diagnosed AOM among otitis-prone children 6 months through 5 years of age. RESULTS: A total of 326 subjects were enrolled, with 160 allocated to xylitol and 166 to placebo. In the primary analysis of time to first clinically diagnosed AOM episode, the hazard ratio for xylitol versus placebo recipients was 0.88 (95% confidence interval [CI] 0.61 to 1.3). In secondary analyses, the incidence of AOM was 0.53 episodes per 90 days in the xylitol group versus 0.59 in the placebo group (difference 0.06; 95% CI -0.25 to 0.13); total antibiotic use was 6.8 days per 90 days in the xylitol group versus 6.4 in the placebo group (difference 0.4; 95% CI -1.8 to 2.7). The lack of effectiveness was not explained by nonadherence to treatment, as the hazard ratio for those taking nearly all assigned xylitol compared with those taking none was 0.93 (95% CI 0.56 to 1.57). CONCLUSIONS: Viscous xylitol solution in a dose of 5 g 3 times per day was ineffective in reducing clinically diagnosed AOM among otitis-prone children.

Management of acute otitis media by primary care physicians: trends since the release of the 2004 American Academy of Pediatrics/American Academy of Family Physicians clinical practice guideline.

OBJECTIVES: In 2004, the American Academy of Pediatrics and the American Academy of Family Physicians released a clinical practice guideline on the management of acute otitis media that included endorsement of an observation option for selected cases and recommendations of specific antibiotics. We sought to describe primary care physicians' current management of acute otitis media to compare it with the guideline's recommendations and describe trends since 2004. DESIGN: We used a mail survey from March through June 2006 within the Slone Center Office-Based Research Network, a national practice-based pediatric research network. RESULTS: The response rate was 299 (62.7%) of 477. The observation option was considered reasonable by 83.3%, compared with 88.0% in 2004, and was used in a median of 15% of acute otitis media cases over the previous 3 months. The most common physician-identified barriers to the use of the observation option were parental reluctance (83.5%) and the cost and difficulty of follow-up of children who do not improve (30.9%). In terms of antibiotic choices for acute otitis media, agreement with the guideline's antibiotic recommendation for 4 common clinical scenarios was as follows: high-dose amoxicillin for acute otitis media with nonsevere symptoms (57.2%), high-dose amoxicillin-clavulanate for acute otitis media with severe symptoms (12.7%), high-dose amoxicillin-clavulanate for cases that failed to respond to amoxicillin (42.8%), and intramuscular ceftriaxone for cases that failed to respond to treatment with amoxicillin-clavulanate (16.7%). Each of these proportions declined from 2004. CONCLUSIONS: Most primary care physicians accept the concept of an observation option for acute otitis media but use it only occasionally. Antibiotics prescribed for acute otitis media differ markedly from the guideline's recommendations, and the difference has increased since 2004.

Validity of parental reporting of recent episodes of acute otitis media: a Slone Center Office-Based Research (SCOR) Network study.

BACKGROUND: The validity of parental reporting of children's health outcomes is an important methodological issue in community-based pediatric research. We assessed the validity of parents' reports of their children's acute otitis media (AOM) history over the previous month in a pilot study of xylitol for AOM prevention. METHODS: Parents of children participating in a study conducted in the Slone Center Office-Based Research (SCOR) Network were interviewed monthly for 3 months and asked whether their child had been diagnosed with AOM in the previous month. A blinded physician reviewed medical records. Results from parental interviews and medical records were compared by correlation analysis. RESULTS: Medical records were obtained for 102 of 120 children (85.0%); 272 monthly interviews were completed. Kappa for the agreement between parental reports and medical records was 0.88 [95% confidence intervals (CI): 0.76 to 0.94]. The positive predictive value of a parental report of an AOM episode within the previous month was 85.0%, and the negative predictive value was 99.1%. CONCLUSIONS: The results of this study suggest that parental reporting of children's recent AOM history correlates well with medical records. Parental interview is a reasonable approach to collecting data on recent AOM outcomes, particularly in large-scale community-based studies where obtaining medical records is often impractical.

Tolerability of oral xylitol solution in young children: implications for otitis media prophylaxis.

OBJECTIVE: Xylitol, given as 2g orally five times-a-day, significantly reduces the incidence of acute otitis media (AOM) in children. A less frequent dosing schedule, if tolerable and efficacious, would promote the more widespread use of this treatment. We sought to determine the tolerability and acceptability in young children of oral xylitol solution at doses of 5g three times-a-day (TID) and 7.5g once daily (QD). METHODS: The study was a 3-month randomized placebo-controlled trial of the tolerability and acceptability of oral xylitol solution in 120 children 6-36 months of age performed in the SCOR Network. RESULTS: Study withdrawals and unscheduled medical visits for gastrointestinal complaints did not differ significantly among the study groups. The proportions of subjects in the xylitol TID group who experienced excessive gas or diarrhea at months 1, 2, and 3 were 22.7%, 10.0%, and 14.3%, respectively, and in the xylitol QD group were 27.3%, 17.4%, and 14.3%, respectively, and these did not differ from the placebo groups. The proportions who accepted the study solution easily or with only minor difficulty at 1, 2, and 3 months in the xylitol TID group were 77.3%, 90.0%, and 90.5% and in the xylitol QD group, 77.3%, 82.6%, and 90.5%, respectively. CONCLUSIONS: Oral xylitol solution at dosages of 5g TID and 7.5g QD is well-tolerated by young children. Given the potential for xylitol as a safe, inexpensive option for AOM prophylaxis, clinical trials using these dosages of xylitol can be conducted.

Characteristics of persistent diarrhea in a community-based cohort of young US children.

OBJECTIVE: The objective of the study was to define the characteristics and microbiology of persistent diarrhea (PD) in US children. METHODS: Six-month prospective cohort study of a convenience sample of 604 healthy 6- to 36-month-old children recruited by the Slone Center Office-based Research Network. RESULTS: Of 611 diarrhea episodes, 50 (8.2%) lasted < or = 14 days. The incidence of PD was 0.18 episodes per person-year, and the median duration of episodes was 22.0 days (range, 14-64 days). PD episodes were more likely than acute episodes to result in a medical visit (28.0% vs 8.2%; P = 0.0001). The most commonly used treatments were oral rehydration solution (12.0% of episodes) and antibiotics (6.0%). No bacterial or parasitic pathogens were associated with PD; but norovirus, rotavirus and sapovirus were each significantly more prevalent in PD stools compared with baseline stools, with relative risks of 12.4, 6.9 and 6.2, respectively. Fifty-nine per cent of the PD specimens tested were negative for all studied pathogens. CONCLUSIONS: PD occurs with a frequency of approximately 1 case per 5 person-years in US infants and young children. It seems to be a generally benign illness, with only 28% of cases presenting to medical care. Although viral pathogens seem to cause a minority of PD episodes in this population, most are not due to currently known infectious agents.

Knowledge and practices relating to the 2004 acute otitis media clinical practice guideline: a survey of practicing physicians.

OBJECTIVE: To identify primary care physicians' familiarity with the 2004 acute otitis media (AOM) clinical practice guideline and to compare their practices with its recommendations. DESIGN: Mail survey October through December 2004 to all active physician members of the Slone Center Office-based Research Network, a national, practice-based, pediatric research network. RESULTS: The response rate was 276 of 469 (58.8%). Overall, 90.5% had read the guideline or summaries of it. Pneumatic otoscopy was always used by 16.2%, used half the time or more by 23.1%, used less than half the time by 34.6% and never used by 26.2%. Observation is considered a reasonable option for some AOM cases by 88.0% and, over the previous 3 months, these physicians used observation a median of 10% of the time (25th and 75th percentiles, 5% and 25%, respectively). In terms of concern that the observation option may increase AOM complications, 75.6% were not at all or only slightly concerned; 24.4% were moderately or very concerned. In general, these physicians have altered their antibiotic prescribing practices for AOM towards the guideline's recommendations since its publication. However, antibiotic choices deviated most widely from the guideline in cases of AOM with severe illness, where only 17.9% follow the recommendation for high-dose amoxicillin-clavulanate, and in cases of children who fail treatment with amoxicillin-clavulanate, where only 27.7% favor the recommended intramuscular ceftriaxone. CONCLUSIONS: Most physicians in this survey are familiar with the AOM guideline, but many do not follow its diagnostic and antibiotic recommendations. Observation for selected cases is acceptable to most of these physicians and is currently used in a small proportion of cases.

Diarrhea in American infants and young children in the community setting: incidence, clinical presentation and microbiology.

OBJECTIVE: The characteristics and microbiology of the full spectrum of pediatric diarrhea occurring in the U.S. community setting are not well-understood. METHODS: Six-month prospective cohort study of 604 healthy 6- to 36-month-old children recruited by the Slone Center Office-based Research Network. RESULTS: The incidence of parent-defined diarrhea was 2.2 episodes per person-year. The median duration of diarrhea was 2 days with a median of 6 stools per episode. Outpatient visits and hospitalization were prompted by 9.7 and 0.3% of episodes, respectively. The most common microorganisms identified in healthy baseline stools were atypical enteropathogenic Escherichia coli (12.2%), enteroaggregative Escherichia coli (3.7%), Clostridium difficile (3.5%) and Clostridium perfringens (2.9%), and each of these was no more common in diarrhea stools. In contrast, all of the viruses analyzed were more prevalent in diarrhea specimens than in baseline specimens: enteric adenovirus (5.7% diarrhea versus 1.4% baseline), rotavirus (5.2% versus 1.4%), astrovirus (3.5% versus 1.4%), Sapporo-like virus (3.0% versus 0.8%) and norovirus (1.9% versus 0.8%). A likely pathogen was detected in 20.6% of diarrhea specimens. Vomiting and > or =16 stools in an episode were predictive of isolating a pathogen from the stool, each with a relative risk of approximately 2. CONCLUSIONS: Healthy young children in this study experienced more than 2 cases of diarrhea per person-year, but most were brief and do not require medical attention. Although most diarrhea-associated pathogens were viruses, no likely pathogen was found in almost 80% of cases; possible etiologies for these cases include currently unknown gastrointestinal infections, nongastrointestinal illnesses and dietary/environmental factors.

Sleep-disordered breathing symptoms are associated with poorer cognitive function in 5-year-old children.

OBJECTIVE: To assess the relation of sleep-disordered breathing (SDB) symptoms in children to neurocognitive function. STUDY DESIGN: A cross-sectional, population-based study of 205 5-year-old children. A parent-completed questionnaire was used to ascertain SDB symptoms, defined as frequent snoring, loud or noisy breathing during sleep, or witnessed sleep apnea. Polysomnography (PSG) data were available in 85% of children. Standardized neurocognitive tests were administered by a trained psychometrist unaware of the children's SDB status. Children with (n=61) and without SDB symptoms were compared using analysis of variance to adjust for demographic and respiratory health variables. RESULTS: Children with SDB symptoms scored significantly lower than those without SDB symptoms on tests of executive function (95.5 vs 99.9 on NEPSY Attention/Executive Core Domain, P=.02; 10.4 vs 11.2 on Wechsler Preschool and Primary Scale of Intelligence, Revised [WPPSI-R] Animal Pegs test, P=.03), memory (96.8 vs 103.0 on NEPSY Memory Domain, P=.02), and general intellectual ability (105.9 vs 111.7 on WPPSI-R Full Scale IQ, P=.02). There were no significant differences on a computerized continuous performance task. These findings persisted when children with PSG evidence of obstructive sleep apnea (OSA) were excluded from analysis. CONCLUSION: Even in the absence of OSA, SDB symptoms are associated with poorer executive function and memory skills and lower general intelligence in 5-year-old children.

Racial/ethnic disparities in the diagnosis of otitis media in infancy.

OBJECTIVE: Otitis media (OM) is an extremely common pediatric diagnosis. Several risk factors have been associated with OM, but the relationship between OM and race/ethnicity remains controversial. We sought to define the relationship between OM diagnosis and race/ethnicity in infants. METHODS: By multivariable logistic regression, we evaluated the association between OM diagnosis and race/ethnicity in 11,349 non-low-birthweight infants who were participants in a prospective cohort study of infant care practices. RESULTS: As in previous studies, breastfeeding was associated with a decreased risk of OM diagnosis while other factors were independently associated with a substantially increased risk of OM diagnosis: out-of-home daycare, multiple children living in the home, and mother's multiparity. Daycare was associated with a "dose effect" in that the risk of OM diagnosis increased with an increasing number of children in the daycare. While the crude analysis suggested little relation of OM diagnosis and race/ethnicity, the association was confounded by several covariates including maternal marital status, number of children living in the home, breastfeeding status, and maternal age. After adjustment for relevant confounders, Black (OR 0.74; 95% CI 0.61-0.89) and Asian infants (OR 0.77; 95% CI 0.57-1.0]) were less likely to be diagnosed with OM than White infants. CONCLUSIONS: This large prospective study confirms previous risk factors for OM and demonstrates a strong "dose effect" of the size of daycare centers on OM. The study also demonstrates that the association between race/ethnicity and OM diagnosis is confounded by social factors. After adjusting for such factors, Black and Asian infants are less likely to be diagnosed with OM than White infants. The reason for this racial disparity remains unknown.

Symptoms of sleep-disordered breathing in 5-year-old children are associated with sleepiness and problem behaviors.

OBJECTIVE: Sleep-disordered breathing (SDB) in children is reportedly associated with problem behaviors suggestive of attention-deficit/hyperactivity disorder; however, there are few data on the relation of SDB to problem behaviors in the general pediatric population. The goal of this study was to assess the prevalence of SDB symptoms in 5-year-old children and their relation to sleepiness and problem behaviors. METHODS: A population-based, cross-sectional survey was conducted of a birth cohort of children who were born in eastern Massachusetts. Subjects were 3019 5-year-old children (1551 boys, 1468 girls) who were enrolled in the Infant Care Practices Study and whose mothers were contacted within 3 months of their child's fifth birthday. A parent-completed questionnaire was used to ascertain the presence and intensity of snoring and other SDB symptoms and the presence of daytime sleepiness and problem behaviors. Parent-reported hyperactivity, inattention, and aggressiveness were each assessed by a single question that was validated against the Conners' Parent Rating Scale. SDB was defined as frequent or loud snoring; trouble breathing or loud, noisy breathing during sleep; or witnessed sleep apnea. RESULTS: Parent-reported hyperactivity (19%) and inattention (18%) were common, with aggressiveness (12%) and daytime sleepiness (10%) reported somewhat less often. SDB symptoms were present in 744 (25%) children. Compared with children without snoring or other symptoms of SDB, children with SDB symptoms were significantly more likely to have parent-reported daytime sleepiness (odds ratio [OR]: 2.2; 95% confidence interval [CI]: 1.7-2.8) and problem behaviors, including hyperactivity (OR: 2.5; CI: 2.0-3.0), inattention (OR: 2.1; 95% CI: 1.7-2.6), and aggressiveness (OR: 2.1; 95% CI: 1.6-2.6). These associations remained significant after adjustment for sex, race/ethnicity, maternal education level, maternal marital status, household income, and respiratory health history. CONCLUSIONS: SDB symptoms are common in 5-year-old children and are associated with an increased risk of daytime sleepiness and with problem behaviors suggestive of attention-deficit/hyperactivity disorder.

Infant sleep position and associated health outcomes.

BACKGROUND: The incidence of sudden infant death syndrome has decreased in the United States as the percentage of infants sleeping prone has decreased, but persisting concerns about the safety of supine sleeping likely contribute to prone sleeping prevalence rates that remain higher than 10%. OBJECTIVE: To document health outcomes in infants aged 1 to 6 months in relation to sleep position. DESIGN: Prospective cohort study. SETTING: Massachusetts and Ohio, from February 21, 1995, to December 31, 1998. STUDY PARTICIPANTS: A total of 3733 infants with consistent sleep positions at ages 1, 3, and 6 months. MAIN OUTCOME MEASURES: Descriptive statistics and multiple logistic regression analysis relating sleep position at each follow-up age to symptoms in the prior week (fever, cough, wheezing, stuffy nose, trouble breathing or sleeping, diarrhea, vomiting, or spitting up) and outpatient visits in the prior month (ear infection, breathing problem, vomiting, spitting up, colic, seizure, accident, or injury). RESULTS: No symptoms or outpatient visits were significantly more common among infants sleeping on the side or supine than in infants sleeping prone, and 3 symptoms were less common: (1) fever at 1 month in infants sleeping in the supine (adjusted odds ratio [OR], 0.56; 95% confidence interval [CI], 0.34-0.93) and side positions (OR, 0.48; 95% CI, 0.28-0.82); (2) stuffy nose at 6 months in the supine (OR, 0.74; 95% CI, 0.61-0.89) and side positions (OR, 0.82; 95% CI, 0.68-0.99); and (3) trouble sleeping at 6 months in the supine (OR, 0.57; 95% CI, 0.44-0.73) and side positions (OR, 0.69; 95% CI, 0.53-0.89). Also, outpatient visits for ear infections were less common at 3 and 6 months in infants sleeping in the supine position (OR, 0.64; 95% CI, 0.46-0.88; and OR, 0.73; 95% CI, 0.58-0.92, respectively) and at 3 months in the side position (OR, 0.68; 95% CI, 0.49-0.96). CONCLUSIONS: No identified symptom or illness was significantly increased among nonprone sleepers during the first 6 months of life. These reassuring results may contribute to increased use of the supine position for infant sleeping.

Sleep position of low birth weight infants.

OBJECTIVES: To describe sleep positions among low birth weight infants, variations in sleep position according to birth weight, and changes in sleep position over time. To analyze risk factors and influences associated with prone sleep. DESIGN: Prospective cohort study. SETTING: Massachusetts and Ohio, 1995-1998. STUDY PARTICIPANTS: Mothers of 907 low birth weight infants. RESULTS: At 1, 3, and 6 months after hospital discharge, the prevalence of prone sleeping was 15.5%, 26.8%, and 28.3%, respectively. The corresponding rates for supine sleeping were 23.8%, 37.9%, and 50.2% and for side sleeping were 57.3%, 32.4%, and 20.6%. Very low birth weight (VLBW) infants (<1500 g) were most likely to be placed in the prone position. From 1995 through 1998, prone sleeping 1 month after hospital discharge declined among all low birth weight infants from 19.9% to 11.4%; among VLBW infants, the decline in prone sleeping was replaced almost entirely by an increase in side sleeping, whereas in larger low birth weight infants, it was replaced primarily by supine sleeping. Among mothers who placed their infants to sleep in nonprone positions, professional medical advice was cited most frequently as the most influential reason, whereas among mothers of prone-sleeping infants, the infant's preference was cited most frequently. However, mothers of prone-sleeping VLBW infants also frequently cited the influence of medical professionals and nursery practices as most important in the choice of sleeping position. The factors most strongly associated with prone sleeping were single marital status (odds ratio [OR]: 3.0; 95% confidence interval [CI]: 1.5-6.2), black race (OR: 2.6; 95% CI: 1.5-4.5), birth weight <1500 g (OR: 2.4; 95% CI: 1.3-4.3), and multiparity (OR: 2.1, 95% CI: 1.2-3.5). CONCLUSIONS: Prone sleep decreased among low birth weight infants from 1995 to 1998. However, VLBW infants, who are at very high risk for sudden infant death syndrome, are more likely to sleep prone than larger low birth weight infants.

Secular changes in sleep position during infancy: 1995-1998.

OBJECTIVE: Prone sleeping among infants has been associated with an increased risk of sudden infant death syndrome. The objective of this study was to compare factors associated with sleep position in 1995-1996 and 1997-1998 and to assess secular trends in use of prone infant sleep position from 1995 through 1998 among families stratified by race and education. METHODS: A prospective cohort study was conducted in eastern Massachusetts and northwest Ohio of 12 029 mothers of infants who weighed > or =2500 g at birth. Descriptive statistics and multivariate odds ratios were used to relate maternal and infant characteristics to prone and supine sleeping. RESULTS: A total of 14 206 mothers (25% of those eligible) were enrolled. A total of 12 029 mothers (85% of enrolled) responded to the 1-month and 11 552 mothers (81% of enrolled) responded to the 3-month follow-up questionnaire. A decline in use of the prone sleep position and increase in use of the supine position was observed during the 4 years of the study. Factors associated with prone and supine sleep position were similar in 1995-1996 and 1997-1998. In 1997-1998, use of prone sleeping at 1 month of age reached the goal of < or =10% only among infants of white and Asian women, married women, women who were older than 25 years, women who were college graduates, and women with incomes >$55 000 per year. At 3 months of age, however, prone sleeping increased to 12% to 17% in these groups. These same groups were most likely to use the supine position; 38% to 45% were supine at 1 month, increasing to 56% to 64% by 3 months of age. However, as of the end of 1998, approximately 27% of infants of non-college-educated black and Hispanic mothers were placed to sleep in the prone position and only 20% to 30% were being placed to sleep in the supine position at 3 months of age. CONCLUSIONS: Recommendations to avoid prone sleep position and especially the recommendation that supine sleep position is preferred have not been effectively delivered to black and Hispanic families and to families of low-income and less than a college education.

Asthma morbidity after the short-term use of ibuprofen in children.

OBJECTIVE: To test the hypothesis that short-term use of ibuprofen increases asthma morbidity in children. METHODS: A randomized, double-blind, acetaminophen-controlled clinical trial was conducted. Children who had asthma and a febrile illness were randomly assigned to receive either acetaminophen suspension or ibuprofen suspension for fever control. Rates of hospitalization and outpatient visits for asthma during follow-up were compared by randomization group. RESULTS: A total of 1879 children receiving asthma medications were studied. Rates of hospitalization for asthma did not vary significantly by antipyretic assignment; compared with children who were randomized to acetaminophen, the relative risk for children who were assigned to ibuprofen was 0.63 (95% confidence interval: 0.25-1.6). However, the risk of an outpatient visit for asthma was significantly lower in the ibuprofen group; compared with children who were randomized to acetaminophen, the relative risk for children who were assigned to ibuprofen was 0.56 (95% confidence interval: 0.34-0.95). CONCLUSIONS: Rather than supporting the hypothesis that ibuprofen increases asthma morbidity among children who are not known to be sensitive to aspirin or other nonsteroidal antiinflammatory drugs, these data suggest that compared with acetaminophen, ibuprofen may reduce such risks. Whether the observed difference in morbidity according to treatment group is attributable to increased risk after acetaminophen use or a decrease after ibuprofen cannot be determined. These data provide evidence of the relative safety of ibuprofen use in children with asthma.