Karen B Fowler

University of Alabama at Birmingham, Birmingham, Alabama, United States

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Publications (54)424.65 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Viral culture of urine or saliva has been the gold standard for the diagnosis of congenital CMV infection. Results of rapid culture and PCR of urine and saliva from 80 children were compared to determine the utility of a real-time PCR assay for congenital CMV diagnosis. Urine PCR was positive in 98.8% of specimens. Three PCR-positive urine samples were culture-negative. Saliva PCR and culture were concordant in 78 specimens (97.5%). Two PCR-positive saliva samples were culture-negative. PCR of urine or saliva is equivalent to rapid culture for congenital CMV diagnosis. Additionally, saliva samples are easier to collect than urine.
    The Journal of Infectious Diseases 05/2014; · 5.85 Impact Factor
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    ABSTRACT: To evaluate differences in presentation and outcomes in children with symptomatic congenital cytomegalovirus (cCMV) identified on newborn screening (screened group) and those identified based on clinical findings at birth (referred group). Data on 178 infants with symptomatic cCMV were analyzed. Demographic characteristics, clinical and laboratory findings documented in the nursery, and sequelae data were compared between the screened and the referred groups using χ(2) or Fisher exact test. Two or more clinical findings were detected at birth in 91% of referred infants, and only 58% of screened infants (P < .001). Significantly more children in the referred group had hearing loss compared with screened infants (P = .009). Fifty-one percent of screened children were free of sequelae compared with only 28% of the referred group (P < .003). Infants with symptomatic cCMV identified based on clinical suspicion have more severe disease at birth and more commonly have sequelae than those identified on newborn screening. Inclusion of referral infants in many previous reports may have overestimated the severity of disease because of selection bias. Defining the complete spectrum of symptomatic disease due to cCMV and providing precise estimates of disease burden can only be gathered from large newborn screening studies.
    The Journal of pediatrics 01/2014; · 4.02 Impact Factor
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    ABSTRACT: Background & objectives: Most studies on the clinical presentation with influenza viruses have been conducted in outpatient or inpatient medical facilities with only a few studies in community settings. Clinical differences between influenza A (H1N1) pdm 09 and influenza B virus infections have importance for community-based public health surveillance. An active community surveillance at the time of emergence of pandemic influenza provided us with an opportunity to compare the clinical features among patients infected with influenza A (H1N1) pdm09 virus and those with influenza B virus co-circulating in an active community-based weekly surveillance in three villages in Faridabad, Haryana, north India. Methods: Active surveillance for febrile acute respiratory infection (FARI) was carried out in a rural community (n=16,182) in the context of an inactivated trivalent influenza vaccine trial (among children <11 yr). Individuals with FARI were assessed clinically by nurses and respiratory samples collected and tested for influenza viruses by real time RT-PCR from November 2009 to August 2010. Clinical symptoms of patients with influenza A (H1N1) pdm 09 and influenza B infection were compared. Results: Of the 4796 samples tested, 822 (17%) were positive for influenza virus. Of these, 443 (54%) were influenza A (H1N1) pdm09, 373 (45%) were influenza B and six were other subtypes/mixed infections. The mean age was lower for patients with influenza B (16.4 yr) than influenza A (H1N1) pdm09 infection (18.7 yr; P=0.04). Among children aged 5-18 yr, chills/rigours (OR 4.0; CI 2.2, 7.4), sore throat (OR 6.8; CI 2.3, 27.3) and headache (OR2.0; CI 1.3, 3.3) were more common in influenza A (H1N1) pdm09 infection than in influenza B cases. Chills/rigours (OR 2.4; CI 1.4, 4.0) and headache (OR 1.7; CI 1.0, 2.7) were associated with influenza A (H1N1) pdm09 infection in those >18 yr. No significant differences were seen in children <5 yr. Conclusion: Our findings show that the differences in the clinical presentation of influenza A(H1N1)pdm09 and influenza B infections are not likely to be of clinical or public health significance.
    The Indian Journal of Medical Research 12/2013; 138(6):962-8. · 2.06 Impact Factor
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    ABSTRACT: Data on influenza illness rates with population denominators are needed to quantify overall morbidity and to prioritize public health intervention strategies. The rates of influenza A(H1N1)pdm09 infection during pandemic phases were determined in a longitudinal community cohort study as part of an influenza vaccine study in a rural community of North India. During the 711 731 person-weeks of surveillance, a total of 1410/7571 (19%) febrile acute respiratory illness cases were positive for influenza. Of these, 749 (53%) were influenza A(H1N1)pdm09, 643 (46%) influenza B, and 18 (1%) influenza A (H3N2). The overall incidence rate of influenza-associated febrile acute respiratory illness was 128/1000 person-years. The incidence rates of influenza A(H1N1)pdm09 were high during both the pandemic phase (179/1000 person-years; November 2009 to January 2010) and post-pandemic phase (156/1000 person-years; August to October 2010), with children <18 years of age being at the greatest risk of influenza infection in the community. These findings provide important information for planning clinical and public health intervention strategies to mitigate the impact of influenza epidemics.
    International journal of infectious diseases: IJID: official publication of the International Society for Infectious Diseases 09/2013; · 2.17 Impact Factor
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    ABSTRACT: Population-based active surveillance in India showed higher incidence rates for influenza A(H1N1)pdm09 among children during pandemic versus postpandemic periods (345 vs. 199/1,000 person-years), whereas adults had higher rates during postpandemic versus pandemic periods (131 vs. 69/1,000 person-years). Demographic shifts as pandemics evolve should be considered in public health response planning.
    Emerging Infectious Diseases 09/2012; 18(9):1472-5. · 6.79 Impact Factor
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    ABSTRACT: 18,500 laboratory-confirmed deaths caused by the 2009 pandemic influenza A H1N1 were reported worldwide for the period April, 2009, to August, 2010. This number is likely to be only a fraction of the true number of the deaths associated with 2009 pandemic influenza A H1N1. We aimed to estimate the global number of deaths during the first 12 months of virus circulation in each country. We calculated crude respiratory mortality rates associated with the 2009 pandemic influenza A H1N1 strain by age (0-17 years, 18-64 years, and >64 years) using the cumulative (12 months) virus-associated symptomatic attack rates from 12 countries and symptomatic case fatality ratios (sCFR) from five high-income countries. To adjust crude mortality rates for differences between countries in risk of death from influenza, we developed a respiratory mortality multiplier equal to the ratio of the median lower respiratory tract infection mortality rate in each WHO region mortality stratum to the median in countries with very low mortality. We calculated cardiovascular disease mortality rates associated with 2009 pandemic influenza A H1N1 infection with the ratio of excess deaths from cardiovascular and respiratory diseases during the pandemic in five countries and multiplied these values by the crude respiratory disease mortality rate associated with the virus. Respiratory and cardiovascular mortality rates associated with 2009 pandemic influenza A H1N1 were multiplied by age to calculate the number of associated deaths. We estimate that globally there were 201,200 respiratory deaths (range 105,700-395,600) with an additional 83,300 cardiovascular deaths (46,000-179,900) associated with 2009 pandemic influenza A H1N1. 80% of the respiratory and cardiovascular deaths were in people younger than 65 years and 51% occurred in southeast Asia and Africa. Our estimate of respiratory and cardiovascular mortality associated with the 2009 pandemic influenza A H1N1 was 15 times higher than reported laboratory-confirmed deaths. Although no estimates of sCFRs were available from Africa and southeast Asia, a disproportionate number of estimated pandemic deaths might have occurred in these regions. Therefore, efforts to prevent influenza need to effectively target these regions in future pandemics. None.
    The Lancet Infectious Diseases 06/2012; 12(9):687-95. · 19.97 Impact Factor
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    ABSTRACT: The burden of disease due to influenza is not well characterized for children in developing countries and the effectiveness of available influenza vaccines in lower resource settings has not been established. We initiated a prospective, longitudinal, phase IV, household-randomized, controlled, observer-blinded three year study (2009-2011) in a rural community of India to measure the total and indirect household protective effects of immunizing children ages 6 months through 10 years with seasonal inactivated trivalent influenza vaccine (TIV) or a control vaccine (n=3697). Active weekly surveillance was conducted year round with home visits for identification of febrile acute respiratory illness (FARI) conducted for all vaccine recipients and household members (n=18,220). Nasal and throat swabs were collected from each FARI episode for influenza detection by real-time reverse transcription polymerase chain reaction. The primary outcome was reduction in laboratory confirmed influenza infections in the influenza vaccine versus control vaccine group, with secondary outcome assessing indirect effects among the entire study population. This report describes the study site, cluster study design, choice of study and control vaccines, and the initial enrollment in the study.
    Vaccine 06/2012; 30(35):5235-9. · 3.77 Impact Factor
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    ABSTRACT: Human metapneumovirus (hMPV) causes acute respiratory infections in children and adults. It is classified into two major genetic lineages and each lineage into two sublineages. The purpose of the study was to identify and characterize hMPV in children who presented to the All India Institute of Medical Sciences, New Delhi, India with acute respiratory infection from April 2005 to March 2007. By reverse-transcription polymerase chain reaction, hMPV was detected in 21 (3%) of the 662 nasopharyngeal samples from children with acute respiratory infection and in none of the 120 control children. Seven of the 21 (33%) children infected with hMPV required hospital admission for pneumonia or bronchiolitis. Most hMPV detections were during the winter and spring seasons. The majority (67%, 11/21) of children positive for hMPV were within 24 months of age. Phylogenetic analysis of partial F and N gene and the full G gene sequences showed three sub-lineages of hMPV circulated during the study period, B1, B2, and the novel sub-lineage A2b. The circulation pattern of hMPV genotypes varied by season. Comparison of the F and G genes of eight strains revealed incongruencies in lineage assignments, raising the possibility that recombination had occurred. Sequence analysis also revealed the F gene was relatively conserved whereas the G gene was more variable between the A and B lineages. This study demonstrates that hMPV is an important contributor to acute respiratory infection in children in India, resulting in both outpatient visits and hospitalizations.
    Journal of Medical Virology 10/2011; 83(10):1799-810. · 2.37 Impact Factor
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    ABSTRACT: Cytomegalovirus (CMV), the most common cause of congenital infection, exhibits extensive genetic variability. We sought to determine whether multiple CMV strains can be transmitted to the fetus and to describe the distribution of genotypes in the saliva, urine, and blood. Study subjects consisted of a convenience sampling of 28 infants found to be CMV-positive on newborn screening as part of an ongoing study. Genotyping was performed on saliva specimens obtained during newborn screening and urine, saliva, and blood obtained at a later time point within the first 3 weeks of life. Six (21.4%) of the 28 saliva samples obtained within the first 2 days of life contained >1 CMV genotype. Multiple CMV genotypes were found in 39% (5/13) of urine, saliva, and blood samples obtained within the first 3 weeks of life from 13 of the 28 newborns. There was no predominance of a CMV genotype at a specific site; however, 4 infants demonstrated distinct CMV strains in different compartments. Infection with multiple CMV strains occurs in infants with congenital CMV infection. The impact of intrauterine infection with multiple virus strains on the pathogenesis and long-term outcome remains to be elucidated.
    The Journal of Infectious Diseases 10/2011; 204(7):1003-7. · 5.85 Impact Factor
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    ABSTRACT: Failure of a cytomegalovirus (CMV) real-time PCR assay targeting glycoprotein B (gB) was investigated. A multiplex assay targeting gB and immediate-early 2 (IE2) genes showed discordant results (gB negative and IE positive or a >10-fold-higher viral load with IE primers) in saliva from 14.6% of CMV-infected newborns. Sequencing revealed 3 patterns of gB variations.
    Journal of clinical microbiology 06/2011; 49(8):3033-5. · 4.16 Impact Factor
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    ABSTRACT: Congenital cytomegalovirus (CMV) infection is an important cause of hearing loss, and most infants at risk for CMV-associated hearing loss are not identified early in life because of failure to test for the infection. The standard assay for newborn CMV screening is rapid culture performed on saliva specimens obtained at birth, but this assay cannot be automated. Two alternatives--real-time polymerase-chain-reaction (PCR)-based testing of a liquid-saliva or dried-saliva specimen obtained at birth--have been developed. In our prospective, multicenter screening study of newborns, we compared real-time PCR assays of liquid-saliva and dried-saliva specimens with rapid culture of saliva specimens obtained at birth. A total of 177 of 34,989 infants (0.5%; 95% confidence interval [CI], 0.4 to 0.6) were positive for CMV, according to at least one of the three methods. Of 17,662 newborns screened with the use of the liquid-saliva PCR assay, 17,569 were negative for CMV, and the remaining 85 infants (0.5%; 95% CI, 0.4 to 0.6) had positive results on both culture and PCR assay. The sensitivity and specificity of the liquid-saliva PCR assay were 100% (95% CI, 95.8 to 100) and 99.9% (95% CI, 99.9 to 100), respectively, and the positive and negative predictive values were 91.4% (95% CI, 83.8 to 96.2) and 100% (95% CI, 99.9 to 100), respectively. Of 17,327 newborns screened by means of the dried-saliva PCR assay, 74 were positive for CMV, whereas 76 (0.4%; 95% CI, 0.3 to 0.5) were found to be CMV-positive on rapid culture. Sensitivity and specificity of the dried-saliva PCR assay were 97.4% (95% CI, 90.8 to 99.7) and 99.9% (95% CI, 99.9 to 100), respectively. The positive and negative predictive values were 90.2% (95% CI, 81.7 to 95.7) and 99.9% (95% CI, 99.9 to 100), respectively. Real-time PCR assays of both liquid- and dried-saliva specimens showed high sensitivity and specificity for detecting CMV infection and should be considered potential screening tools for CMV in newborns. (Funded by the National Institute on Deafness and Other Communication Disorders.).
    New England Journal of Medicine 06/2011; 364(22):2111-8. · 51.66 Impact Factor
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    ABSTRACT: Viruria and DNAemia patterns were investigated in 205 seroimmune women enrolled in a prospective cytomegalovirus (CMV) reinfection study. CMV DNA was detected at least once in urine and blood specimens from 83% and 52% of patients, respectively. At baseline, 39% of patients had viruria, and 24% had DNAemia. Intermittent viruria and viremia was observed throughout the study. There were no differences in baseline CMV positivity by polymerase chain reaction or in longitudinal DNAemia and viruria between the women with and without serological evidence of reinfection. In young seropositive women, CMV DNAemia and viruria are common, which suggests that naturally acquired immunity to CMV does not alter shedding patterns.
    The Journal of Infectious Diseases 11/2010; 202(12):1800-3. · 5.85 Impact Factor
  • Suresh B Boppana, Karen B Fowler, Shannon A Ross
    JAMA The Journal of the American Medical Association 07/2010; 304(4):407-408. · 29.98 Impact Factor
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    ABSTRACT: Reliable methods to screen newborns for congenital cytomegalovirus (CMV) infection are needed for identification of infants at increased risk of hearing loss. Since dried blood spots (DBS) are routinely collected for metabolic screening from all newborns in the United States, there has been interest in using DBS polymerase chain reaction (PCR)-based methods for newborn CMV screening. To determine the diagnostic accuracy of DBS real-time PCR assays for newborn CMV screening. Between March 2007 and May 2008, infants born at 7 US medical centers had saliva specimens tested by rapid culture for early antigen fluorescent foci. Results of saliva rapid culture were compared with a single-primer (March 2007-December 2007) and a 2-primer DBS real-time PCR (January 2008-May 2008). Infants whose specimens screened positive on rapid culture or PCR had congenital infection confirmed by the reference standard method with rapid culture testing on saliva or urine. Sensitivity, specificity, and positive and negative likelihood ratios (LRs) of single-primer and 2-primer DBS real-time PCR assays for identifying infants with confirmed congenital CMV infection. Congenital CMV infection was confirmed in 92 of 20,448 (0.45%; 95% confidence interval [CI], 0.36%-0.55%) infants. Ninety-one of 92 infants had positive results on saliva rapid culture. Of the 11,422 infants screened using the single-primer DBS PCR, 17 of 60 (28%) infants had positive results with this assay, whereas, among the 9026 infants screened using the 2-primer DBS PCR, 11 of 32 (34%) screened positive. The single-primer DBS PCR identified congenital CMV infection with a sensitivity of 28.3% (95% CI, 17.4%-41.4%), specificity of 99.9% (95% CI, 99.9%-100%), positive LR of 803.7 (95% CI, 278.7-2317.9), and negative LR of 0.7 (95% CI, 0.6-0.8). The positive and negative predictive values of the single-primer DBS PCR were 80.9% (95% CI, 58.1%-94.5%) and 99.6% (95% CI, 99.5%-99.7%), respectively. The 2-primer DBS PCR assay identified infants with congenital CMV infection with a sensitivity of 34.4% (95% CI, 18.6%-53.2%), specificity of 99.9% (95% CI, 99.9%-100.0%), positive LR of 3088.9 (95% CI, 410.8-23 226.7), and negative LR of 0.7 (95% CI, 0.5-0.8). The positive and negative predictive values of the 2-primer DBS PCR were 91.7% (95% CI, 61.5%-99.8%) and 99.8% (95% CI, 99.6%-99.9%), respectively. Among newborns, CMV testing with DBS real-time PCR compared with saliva rapid culture had low sensitivity, limiting its value as a screening test.
    JAMA The Journal of the American Medical Association 04/2010; 303(14):1375-82. · 29.98 Impact Factor
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    ABSTRACT: Cytomegalovirus (CMV) reinfections have been associated with damaging congenital infection and adverse outcomes in transplant recipients. To determine the frequency of and risk factors for CMV reinfections, 205 seropositive women were followed up prospectively. The appearance of new antibody specificity against 1 of 4 polymorphic epitopes was considered as evidence of CMV reinfection. Approximately one-third of the study participants (59 [29%] of 205) were noted to have CMV reinfection during follow-up. None of the exposure factors were associated with CMV reinfection. Women with antibodies against at least 1 of the 4 antigens at baseline had a 63% decreased risk of reinfection, suggesting a protective role for strain-specific immunity.
    The Journal of Infectious Diseases 02/2010; 201(3):386-9. · 5.85 Impact Factor
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    ABSTRACT: The pathogenesis of cytomegalovirus (CMV)-related hearing loss is not well understood. To evaluate the relationship between persistent CMV shedding and delayed sensorineural hearing loss in children born with congenital CMV. Serial audiologic assessments and CMV cultures of urine and saliva were performed on 580 children who had been diagnosed with congenital CMV infection. Prevalence of CMV culture-positivity in any specimen decreased to approximately 50% by the third birthday and approximately 5% after the seventh birthday. Intermittent shedding occurred in 28% of children. Seventy-seven children had hearing loss at birth and 38 children developed delayed hearing loss by the end of follow-up. In multivariate analyses, delayed hearing loss was strongly associated with symptomatic infection at birth (OR = 5.9, 95% CI: 1.8-18.9) and modestly associated with older age at last culture-positive visit (OR = 1.6, 95% CI: 1.1-2.0, comparing 1-year age differences) Observed rates of delayed hearing loss were 0.79 per 100 person-years for children asymptomatic at birth and 4.29 per 100 person-years for children symptomatic at birth. Between the ages of 6 months and 8 years, we would expect delayed hearing loss to occur in 6.9% of asymptomatic children and in 33.7% of symptomatic children. The strongest risk factor for delayed hearing loss was CMV-related symptoms at birth, but many asymptomatic children also developed delayed hearing loss. Longer duration of CMV shedding may also be a predictor of delayed hearing loss.
    The Pediatric Infectious Disease Journal 07/2009; 28(6):515-20. · 3.57 Impact Factor
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    ABSTRACT: This study was designed to determine whether elevated viral load in infants and young children is associated with congenital cytomegalovirus (CMV)-related hearing loss. Blood samples were obtained from 135 children with congenital CMV infection. CMV DNA in the peripheral blood was quantitated with a real-time polymerase chain reaction assay. Viral load measurements were analyzed in 3 different age groups (<2 months, 2-12 months, 12-36 months). In children with symptomatic and asymptomatic infection, CMV DNA levels were not different between children with hearing deficit and those with normal hearing in all 3 age groups. In children with asymptomatic infection, the positive predictive value of a peripheral blood viral load >3500 genomic equivalents per milliliter (ge/mL) at <2 months and 2 to 12 months of age is 8%, and at 12 to 36 months of age is 11.8%. However, the negative predictive value of a viral load <3500 ge/mL is 94.4% at <2 months of age, and 100% at 2 to 36 months of age. Peripheral blood viral load is not associated with hearing loss in children with congenital CMV infection. However, a viral load of <3500 ge/mL is associated with a lower risk of hearing loss in children born with asymptomatic congenital infection.
    The Pediatric Infectious Disease Journal 05/2009; 28(7):588-92. · 3.57 Impact Factor
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    ABSTRACT: To determine the incidence and natural history of congenital cytomegalovirus (CMV) infection in a population of women with near universal serologic reactivity for CMV, a prospective study of 423 women attending the antenatal clinic of the Comprehensive Rural Health Center in northern India was conducted. All 9 (2.1%) CMV positive infants were born to mothers who were CMV seropositive at the first antenatal visit. One child had hepatosplenomegaly at birth and another child had mild unilateral hearing loss at 4 months of age.
    The Pediatric Infectious Disease Journal 09/2008; 27(9):841-3. · 3.57 Impact Factor
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    ABSTRACT: We examined the impact of advanced maternal age (>40 years old) on the survival of twin small-for-gestational-age (SGA) infants, that is, infants who were smaller in size than was expected for the baby's sex, genetic heritage, and gestational age. The present study was a retrospective cohort study on twin live births in the USA from 1995 to 1998 inclusive. Two categories of SGA babies were defined: discordant (when only one of a twin pair was SGA) and concordant (when both were SGA). Otherwise, the twin pair was appropriate-for-gestational-age (AGA) concordant. 192,195 twin pairs were analyzed. The incidence of SGA discordance and concordance was 11.8% and 3.9%, respectively. The occurrence of both SGA subtypes tended to decrease with increasing maternal age. The unadjusted risk for neonatal mortality increased when both twins were affected (15.8: 22.8 and 56.6 per 1000 among AGA concordant, SGA discordant and SGA concordant twins; P-value for trend < 0.0001). Using maternal-age-specific AGA babies as reference, the adjusted risk for neonatal mortality climbed progressively with advancing maternal age in a dose-dependent pattern, being lowest among teenagers and highest in mothers aged > or =40 years. SGA discordance and concordance declined with advancing maternal age. In contrast, neonatal mortality of both SGA subtypes worsened with the increase in maternal age compared with that of the age-specific AGA infants. These findings are potentially useful to care providers in counseling older women, a group that is progressively increasing in size and is most susceptible to twining.
    Journal of Obstetrics and Gynaecology Research 07/2007; 33(3):259-65. · 0.84 Impact Factor
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    ABSTRACT: Congenital cytomegalovirus (CMV) infection is a leading cause of sensorineural hearing loss (SNHL) in children. Whether connexin mutations are factors in the development of CMV-related hearing loss has not been explored. We examined gap junction protein beta-2 (GJB2) and gap junction protein beta-6 (GJB6) mutations in 149 children with congenital CMV infection and 380 uninfected neonates. Mutations in GJB2 and GJB6 were assessed by nucleotide sequencing and polymerase chain reaction (PCR) methods, respectively. The study population was predominantly African American, and 4.3% of the subjects were carriers of a connexin 26 mutation. The overall frequency of GJB2 mutations was significantly higher in the group of children with CMV infection and hearing loss (21%) compared with those with CMV infection and normal hearing (3%, p = 0.017) and the group of uninfected newborns (3.9%, p = 0.016). Eight previously reported mutations (M34T, V27I, R127H, F83L, R143W, V37I, V84L, G160S), and four novel mutations (V167M, G4D, A40T, and R160Q) were detected. None of the study children had the 342-kb deletion (delGJB6-D13S1830) in GJB6, which suggests that this mutation does not play a role in hereditary deafness in the African American population. Although GJB2 mutations were detected in children with and without CMV-related hearing loss, those with hearing loss had a higher frequency of GJB2 mutations.
    Pediatric Research 06/2007; 61(6):687-91. · 2.67 Impact Factor

Publication Stats

3k Citations
424.65 Total Impact Points

Institutions

  • 1991–2014
    • University of Alabama at Birmingham
      • • Department of Pediatrics
      • • Department of Medicine
      Birmingham, Alabama, United States
  • 2006–2011
    • All India Institute of Medical Sciences
      • Department of Microbiology
      New Delhi, NCT, India
  • 2007
    • Cambridge Eco
      Cambridge, England, United Kingdom