[Show abstract][Hide abstract] ABSTRACT: Dosages of vitamin D necessary to prevent or treat vitamin D deficiency in children remain to be clarified.
To determine the effects of vitamin D3 1000 IU/day on serum 25(OH)D, PTH, and markers of bone turnover (osteocalcin and collagen type 1 cross-linked C-telopeptide) in black and in white children; and to explore whether there is a threshold level of 25(OH)D associated with maximal suppression of serum PTH concentration.
Healthy 8- to 14-yr-old Pittsburgh-area black (N=84) and white (N=73) children not receiving vitamin supplements, enrolled during October through March of 2008 through 2011, were randomized to vitamin D3 1000 IU or placebo daily for 6 months.
The mean baseline concentration of 25(OH)D was <20 ng/mL in both the vitamin D-supplemented and the placebo group (19.8±7.6 and 18.8±6.9 ng/mL, respectively). Mean concentration was higher in the supplemented group than in the placebo group at 2 months (26.4±8.1 vs 18.9±8.1 ng/mL, P<0.0001) and also at 6 months (26.7±7.6 vs. 22.4±7.3, P=0.003), after adjusting for baseline 25(OH)D, race, gender, pubertal status, dietary vitamin D intake, body mass index, and sunlight exposure. Increases were significant only in black children, when examined by race. The association between 25(OH)D and PTH concentrations was inverse and linear without evidence of a plateau. Overall, vitamin D supplementation had no effect on PTH and bone turnover.
Vitamin D3 supplementation with 1000 IU/day in children with mean baseline 25(OH)D concentration <20 ng/mL effectively raised their mean 25(OH)D concentration to ≥20 ng/mL but failed to reach 30 ng/mL. Vitamin D supplementation had no effect on PTH concentrations.
The Journal of Clinical Endocrinology and Metabolism 06/2015; DOI:10.1210/jc.2015-1643 · 6.31 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background: Surveillance of children with acute otitis media (AOM) for nasopharyngeal colonization with Streptococcus pneumoniae before, during and after the introduction of 7-valent pneumococcal conjugate vaccine (PCV7) indicated the near-complete elimination of PCV7 strains and the emergence of pneumococcal serotype 19A. Methods: To determine effects of the introduction of 13-valent pneumococcal conjugate vaccine (PCV13) on pneumococcal nasopharyngeal colonization, we obtained nasopharyngeal cultures from 228 children 6 through 23 of age months presenting with a new episode of AOM during 2012 and 2013 and enrolled in an ongoing clinical trial of antimicrobial efficacy. All children had received at least 2 doses of PCV13. The S. pneumoniae isolates were subjected to serotyping and testing for antimicrobial susceptibility. We compared the findings with results obtained in 3 earlier studies. Results: We found nasopharyngeal colonization with S. pneumoniae in 113 (50%) of the children with AOM. PCV7 and PCV13 serotypes accounted for 2% and 12%, respectively, of the pneumococcal isolates. Of the 14 PCV13 isolates, 8 were serotype 19A. Nonvaccine serotypes accounted for 69% of the isolates. Most frequently occurring were sub-types of serotype 15 (23%) and serotype 35B (9%). Overall, 33% of the isolates were penicillin nonsusceptible, a proportion not significantly different from proportions found in our 3 earlier studies (26%, 36% and 37%, respectively). Serotypes 15 and 35B accounted for 51% of penicillin-nonsusceptible isolates. Conclusions: Expansion of contents of pneumococcal vaccine administered to children is followed by not-fully-predictable changes in nasopharyngeal pneumococcal colonization. Continued surveillance is required to help inform future vaccine development.
[Show abstract][Hide abstract] ABSTRACT: Seasonal fluxes in 25-hydroxyvitamin D [25(OH)D] in children can impact bone turnover, and in turn potentially affect bone accrual and peak bone mass.
To examine the effect of seasonal flux on the association among 25(OH)D and parathyroid hormone (PTH) on markers of bone turnover in pre- and early pubertal black and white children.
Data were collected during summer (June -September) and winter (December - March) in 6- to 12-yr-old children. Measurements included serum 25(OH)D, PTH, osteocalcin (OC), collagen type 1 cross-linked C-telopeptide (CTx), dietary intake of vitamin D and calcium, skin color, sunlight exposure, and body-mass-index (BMI).
A total of 138 children (mean [±SD] age: 9.1±1.7 year, black: 94, male: 81) were studied. 25(OH)D (41.2±13 vs 34.5±11.1 ng/mL, p<0.001) were higher and CTx were lower (0.8±0.3 vs 0.9±0.5 ng/mL, p<0.001) in all participants during summer when compared to winter. Furthermore, seasonal differences in CTx were more pronounced in blacks (summer: 0.7±0.3 vs winter: 1.0±0.5 ng/mL, p<0.001). PTH was a significant predictor of serum CTx and OC after adjusting for race, season, Tanner stage, dietary calcium, skin color and BMI.
25(OH)D declined significantly in both black and whites during winter. CTx significantly increased during winter in blacks than whites suggesting increased rates of resorption in blacks during winter. Benefits of enhancement of wintertime vitamin D status on bone health need further exploration.
Pediatrics International 09/2013; DOI:10.1111/ped.12210 · 0.73 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: OBJECTIVE:: Differentiating acute bacterial sinusitis from viral upper respiratory tract infection (URI) is challenging; 20% to 40% of children diagnosed with acute sinusitis based on clinical criteria likely have an uncomplicated URI. The objective of this study was to determine which signs and symptoms could be used to identify the subgroup of children who meet current clinical criteria for sinusitis but who nevertheless have a viral URI. METHODS:: We obtained sinus radiographs in consecutive children meeting a priori clinical criteria for acute sinusitis. We considered the subgroup of children with completely normal sinus radiographs to have an uncomplicated URI despite meeting the clinical diagnostic criteria for sinusitis. We examined the utility of signs and symptoms in identifying children with URI. RESULTS:: Of 258 children enrolled, 54 (20.9%) children had completely normal radiographs. The absence of green nasal discharge, the absence of disturbed sleep, and mild symptoms were associated with a diagnosis of URI. No physical exam findings were particularly helpful in distinguishing between children with normal vs. abnormal radiographs. CONCLUSIONS:: Among children meeting current criteria for the diagnosis of acute sinusitis, those with mild symptoms are significantly more likely to have a URI than those with severe symptoms. In addition to assessing overall severity of symptoms, practitioners should ask about sleep disturbance and green nasal discharge when assessing children with suspected sinusitis; their absence favors a diagnosis of URI.
[Show abstract][Hide abstract] ABSTRACT: IMPORTANCE A child's health, positive perceptions of the research team and consent process, and altruistic motives play significant roles in the decision-making process for parents who consent for their child to enroll in clinical research. This study identified that nonconsenting parents were better educated, had private insurance, showed lower levels of altruism, and less understanding of study design. OBJECTIVE To determine the factors associated with parental consent for their child's participation in a randomized, placebo-controlled trial. DESIGN Cross-sectional survey conducted from July 2008 to May 2011. The survey was an ancillary study to the Randomized Intervention for Children with VesicoUreteral Reflux Study. SETTING Seven children's hospitals participating in a randomized trial evaluating management of children with vesicoureteral reflux. PARTICIPANTS Parents asked to provide consent for their child's participation in the randomized trial were invited to complete an anonymous online survey about factors influencing their decision. A total of 120 of the 271 (44%) invited completed the survey; 58 of 125 (46%) who had provided consent and 62 of 144 (43%) who had declined consent completed the survey. MAIN OUTCOMES AND MEASURES A 60-question survey examining child, parent, and study characteristics; parental perception of the study; understanding of the design; external influences; and decision-making process. RESULTS Having graduated from college and private health insurance were associated with a lower likelihood of providing consent. Parents who perceived the trial as having a low degree of risk, resulting in greater benefit to their child and other children, causing little interference with standard care, or exhibiting potential for enhanced care, or who perceived the researcher as professional were significantly more likely to consent to participate. Higher levels of understanding of the randomization process, blinding, and right to withdraw were significantly positively associated with consent to participate. CONCLUSIONS AND RELEVANCE Parents who declined consent had a relatively higher socioeconomic status, had more anxiety about their decision, and found it harder to make their decision compared with consenting parents, who had higher levels of trust and altruism, perceived the potential for enhanced care, reflected better understanding of randomization, and exhibited low decisional uncertainty. Consideration of the factors included in the conceptual model should enhance the quality of the informed consent process and improve participation in pediatric clinical trials.
[Show abstract][Hide abstract] ABSTRACT: Seasonal variation of vitamin D status and adequacy of dietary vitamin D and impact of race on maintaining vitamin D sufficiency was assessed in 140 healthy 6- to 12-year-old African American (AA) and Caucasian (C) children residing in Pittsburgh, Pennsylvania during summer and winter. Vitamin D insufficiency was not rare in either group (AA vs C, summer, 17.2% vs 14.3%, nonsignificant; winter, 34.1% vs 32.5%, nonsignificant) despite a mean dietary intake of vitamin D above the American Academy of Pediatrics (AAP) recommended intake (400 IU/d; AA vs C, summer, 421 vs 456 IU/d, nonsignificant; winter, 507 vs 432 IU/d, nonsignificant). Race/season and dietary vitamin D were predictors of serum 25-hydroxyvitamin D [25(OH)D] concentrations. However, dietary vitamin D influenced 25(OH)D only in Caucasians during winter. Current AAP recommended daily intake for vitamin D is inadequate for maintaining vitamin D sufficiency in children.
[Show abstract][Hide abstract] ABSTRACT: Recommendations vary regarding immediate antimicrobial treatment versus watchful waiting for children younger than 2 years of age with acute otitis media.
We randomly assigned 291 children 6 to 23 months of age, with acute otitis media diagnosed with the use of stringent criteria, to receive amoxicillin-clavulanate or placebo for 10 days. We measured symptomatic response and rates of clinical failure.
Among the children who received amoxicillin-clavulanate, 35% had initial resolution of symptoms by day 2, 61% by day 4, and 80% by day 7; among children who received placebo, 28% had initial resolution of symptoms by day 2, 54% by day 4, and 74% by day 7 (P=0.14 for the overall comparison). For sustained resolution of symptoms, the corresponding values were 20%, 41%, and 67% with amoxicillin-clavulanate, as compared with 14%, 36%, and 53% with placebo (P=0.04 for the overall comparison). Mean symptom scores over the first 7 days were lower for the children treated with amoxicillin-clavulanate than for those who received placebo (P=0.02). The rate of clinical failure--defined as the persistence of signs of acute infection on otoscopic examination--was also lower among the children treated with amoxicillin-clavulanate than among those who received placebo: 4% versus 23% at or before the visit on day 4 or 5 (P<0.001) and 16% versus 51% at or before the visit on day 10 to 12 (P<0.001). Mastoiditis developed in one child who received placebo. Diarrhea and diaper-area dermatitis were more common among children who received amoxicillin-clavulanate. There were no significant changes in either group in the rates of nasopharyngeal colonization with nonsusceptible Streptococcus pneumoniae.
Among children 6 to 23 months of age with acute otitis media, treatment with amoxicillin-clavulanate for 10 days tended to reduce the time to resolution of symptoms and reduced the overall symptom burden and the rate of persistent signs of acute infection on otoscopic examination. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT00377260.).
New England Journal of Medicine 01/2011; 364(2):105-15. DOI:10.1056/NEJMoa0912254 · 54.42 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The objective of this study was to develop a patient-reported outcome measure (Strep-PRO) for assessing symptoms of group A Streptococcus (GAS) pharyngitis from the child's point of view and to present preliminary data on its internal reliability, construct validity, and responsiveness.
We selected 8 symptoms for inclusion in the Strep-PRO. We used the Strep-PRO to assess improvement in children who were aged 5 to 15 years and had confirmed GAS pharyngitis. Children completed the scale at study visits and as a diary at home. To evaluate internal reliability, we examined correlations between the items on the scale. To evaluate construct validity, we examined the correlation at entry between Strep-PRO scores and scores on other, previously validated measures of pain and functional status. To evaluate responsiveness, we examined the change in score from enrollment to follow-up. The correlation between the Strep-PRO score and parental assessment of symptoms was also evaluated.
A total of 131 children were enrolled; 113 returned completed diaries. The internal reliability of the scale was high. The magnitude of correlations between Strep-PRO scores and other measures of pain and functional status ranged from 0.39 to 0.63. The responsiveness of the Strep-PRO was very good. The overall level of agreement between child Strep-PRO scores and parental assessment of symptoms was 0.57.
The scale seems to measure effectively both pain and overall functional status in children with GAS pharyngitis. These data support the use of Strep-PRO as a measure of outcome in future clinical trials.
[Show abstract][Hide abstract] ABSTRACT: We developed a program for training in the diagnosis of otitis media that included images illustrating various otoscopic findings, mnemonic guides to recollection, and discrimination sessions that included feedback and assessments of diagnostic skills.
We prepared a computerized, interactive curriculum, Enhancing Proficiency in Otitis Media (ePROM), that was centered around assemblages of clinically diverse, still and video images of tympanic membranes (TMs). To assess curriculum effectiveness, we constructed a test, the Diagnostic Ear Assessment Resource, that consisted of 50 video TM images. We administered the test to 84 residents in pediatrics or family practice who had not been exposed to ePROM and, varying the order in which the images were presented, to another group of 102 residents in the same programs both before and after exposure to ePROM.
o Mean proportions of correct diagnoses in the Diagnostic Ear Assessment Resource were larger among residents who had been exposed to ePROM than among residents at comparable levels of training who had not been exposed (67% vs 62%; P = .007). Among residents exposed to ePROM, mean proportions of correct diagnoses were larger after exposure than before (67% vs 55%; P < .001).
A structured, computerized curriculum to supplement standard clinical training can enhance residents' abilities to interpret still and video images of TMs and may improve their skills in diagnosing otitis media.
[Show abstract][Hide abstract] ABSTRACT: Vague terminology is a problem in cleft palate research. No classification scheme for palatal fistulas has been proposed to date. Although a well-healed velum is a significant outcome of palatoplasty, it is nearly impossible to compare fistula-related palatoplasty results in the literature or in medical records without a standardized vocabulary. We endeavor to devise a palatal fistula classification system that may have clinical and research applicability.
PubMed was searched for definitions and classifications of palatal fistula as well as incidence and recurrence rates of this outcome. Next, a 25-year retrospective review of our Cleft Center's records was performed, and fistulas were identified (n=641 charts reviewed). The fistula descriptions yielded by this chart review were evaluated in the context of anatomical descriptions in the literature, and a clinician-friendly classification scheme was designed.
A literature review failed to reveal a standardized fistula classification system. An anatomically based numerical fistula classification system was devised: type I, bifid uvula; type II, soft palate; type III, junction of the soft and hard palate; type IV, hard palate; type V, junction of the primary and secondary palates (for Veau IV clefts); type VI, lingual alveolar; and type VII, labial alveolar.
We propose a standardized numerical classification system for palatal fistulas. Its clinical adoption may prospectively clarify ambiguities in the literature and facilitate future cleft palate research and clinical practice.
[Show abstract][Hide abstract] ABSTRACT: The straight-line palatoplasty with intravelar veloplasty (IVVP) is one option for cleft palate repair. However, not all IVVPs are performed uniformly. Many IVVPs only address the medialmost portion of the levator muscle, an "incomplete IVVP," failing to completely dissect and adequately transpose the entire levator muscle, "complete IVVP." We believe that for optimal speech results, IVVPs should completely mobilize and posteriorly displace the levator. We propose that a conversion Furlow palatoplasty performed with a "complete IVVP" will correct postoperative velopharyngeal insufficiency (VPI) and alleviate the need for pharyngoplasty.
Nineteen patients with postoperative VPI, having had prior straight-line palatoplasty and reported "IVVP," underwent conversion Furlow palatoplasty. Those with a pre- and postoperative Pittsburgh Weighted Speech Scale (PWSS) value and no other history of palatal surgeries were included in this study. Statistical analysis was performed by using the Wilcoxon signed ranks test.
Patients' median age was 5.5 years (range, 4-15 years), with 13 males and 7 females. The median preoperative PWSS score was 11.00 (range, 3-24.5), and the median postoperative was 1.00 (range, 0-5) (P < 0.001). All subcategories of the PWSS were also improved. Eight children had a preoperative fistula, and all were successfully corrected. At the time of conversion Furlow palatoplasty, all patients demonstrated no evidence of previous IVVP as the levator muscle was found to be scarred to the posterior edge of the hard palate.
The conversion Furlow palatoplasty can be used to significantly improve VPI and salvage speech after a straight-line palatoplasty with an "incomplete IVVP." Patients with postoperative VPI should first be considered for conversion Furlow palatoplasty performed with a "complete IVVP" prior to progressing to pharyngoplasty.
Annals of Plastic Surgery 06/2006; 56(5):505-10. DOI:10.1097/01.sap.0000210154.72830.3d · 1.46 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: It has been suggested that urinary tract infections (UTIs) early in life predispose to dysfunctional elimination syndrome (DES). This study evaluated the relationship between early UTI, vesicoureteral reflux (VUR), and DES by comparing two cohorts of school-aged children.
The UTI cohort (n = 123) included children previously enrolled in a prospective treatment trial conducted between 1992 and 1997. All were diagnosed with a febrile UTI before 2 years of age. The comparison cohort (n = 125) included children who were evaluated for fever in the emergency department between 1992 and 1997, whose urine culture was negative. Dysfunctional elimination symptoms were compared in the two cohorts by having families complete a revised version of the Dysfunctional Voiding Scoring System.
Completed questionnaires were received from 248 children. There were no significant differences in selected demographic or clinical characteristics between the two cohorts. DES was present in 22% and 21% of children with and without a history of early UTI, respectively. Among children with UTIs, 18% of those with VUR and 25% of those without VUR had DES.
Dysfunctional elimination is common in a general pediatric population. Neither UTI nor VUR diagnosed before 2 years of age was associated with DES in school-aged children.
[Show abstract][Hide abstract] ABSTRACT: Acute otitis media (AOM) frequently complicates influenza infection. Previous studies have found influenza vaccine effective in reducing the occurrence of AOM in children mainly older than 2 years.
To evaluate the effectiveness of inactivated influenza vaccine in preventing AOM in children aged 6 to 24 months.
Randomized, double-blind, placebo-controlled trial of 786 children aged 6 to 24 months enrolled at Children's Hospital of Pittsburgh before the 1999-2000 (411 children) and 2000-2001 (375 children) respiratory seasons (defined as December 1 through March 31 of the respective following year). Children received influenza vaccine or placebo in a 2:1 ratio. The first cohort was observed for 1 year and the second cohort until the end of the ensuing respiratory season.
Two doses (0.25 mL each) of inactivated trivalent subvirion influenza vaccine or placebo were administered intramuscularly approximately 4 weeks apart.
Proportion of children who developed AOM, monthly occurrence rate of AOM, estimated proportion of time with middle ear effusion, and utilization of selected health care and related resources.
Of the 66 children in the vaccine group from whom serum samples were collected, seroconversion against strains in the vaccine formulations developed in 88.6% to 96.8%, depending on the specific strain. The efficacy of the vaccine against culture-confirmed influenza was 66% (95% confidence interval [CI], 34%-82%) in 1999-2000 and -7% (95% CI, -247% to 67%) in 2000-2001; however, influenza attack rates differed between these 2 periods (in the placebo group, 15.9% and 3.3%, respectively). Compared with placebo, influenza vaccine did not reduce the proportion of children who had at least 1 episode of AOM during the respiratory season (in the first cohort: vaccine, 49.2% vs placebo, 52.2%; P =.56 ]; in the second cohort: vaccine, 55.8% vs placebo, 48.3%; P =.17). The vaccine also did not reduce the monthly rate of AOM; the estimated proportion of time with middle ear effusion; or the utilization of selected health care and related resources. There were also no differences between the vaccine and placebo groups regarding any of these outcomes during peak influenza periods. The vaccines administered to both cohorts of children were well tolerated.
Administration of inactivated trivalent influenza vaccine to children aged 6 to 24 months did not reduce their burden of AOM or their utilization of selected health care and related resources.
JAMA The Journal of the American Medical Association 10/2003; 290(12):1608-16. DOI:10.1001/jama.290.12.1608 · 30.39 Impact Factor