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Principal Investigator: Irene A. Stafford
Organization: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
Fiscal Year: 2024
Award: $654,914
Funding agency: Eunice Kennedy Shriver National Institute of Child Health and Human Development
Abstract
The re-emergence in maternal and congenital syphilis (CS) infection in recent years has brought
this sexually transmitted infection (STI) to the forefront of policy discussions among federal and
state health and human services departments. The recommended tests at birth demonstrate poor
sensitivity for the diagnosis of CS, necessitating longitudinal follow up for up to 18 months until
infection can be definitively excluded. This strategy inevitably results in cases of delayed or even
missed treatment, leading to serious adverse outcomes that could have been prevented. With data
suggesting a missed diagnosis rate approaching 15%, there is an urgent need for improved
diagnostic modalities to detect CS through direct identification ofT. pallidum using highly
sensitive contemporary nucleic acid amplification tests (NAA Ts). Two potential options include:
real-time quantitative polymerase chain reaction (qPCR) and the Aptima Treponema pallidum
transcription-mediated amplification (TMA) assay. By directly detecting the pathogen in
neonatal biospecimens, these assays may provide more timely detection of CS in order to initiate
timely evaluations and treatment. The aim of this study is to conduct a large, multicenter,
prospective observational cohort trial of 924 maternal and neonatal dyads at risk for CS to
effectively evaluate the test performance of these NAATs compared to the 2021 STD CS
infection categories assigned to that patient at birth ( confirmed proven/highly probable, possible
CS, CS less likely, CS unlikely) to determine if a superior diagnostic algorithm exists.
Longitudinal follow up confirming infection status will be performed up to 18 months of age.
Based on existing scientific premise, our central hypothesis is that the contemporary NAA Ts will
result in a more sensitive, specific and timely diagnosis of congenital infection with T. pallidum
compared to the standard recommended testing algorithms. In addition, we plan to leverage the
resulting clinical cohort to more accurately define adverse neurodevelopmental outcomes
associated with CS. This study will be the first to evaluate neurodevelopmental outcomes of
affected children by performing Bayley Scales of Infant and Toddler Development™ at 18
months on the offspring of infected women. Beyond the importance of this research in terms of
pure science, the results could have far-reaching public health implications that may contribute to
improved quality and guideline efforts.
Terms: <0-11 years old><0-4 weeks old><21+ years old><Active Follow-up><Address><Adult><Adult Human><Affect><Age Months><Algorithms><Assay><Bioassay><Biological Assay><Birth><Blinded><Blood><Blood Reticuloendothelial System><CNS Nervous System><Categories><Cells Placenta-Tissue><Centers for Disease Control><Centers for Disease Control and Prevention><Centers for Disease Control and Prevention (U.S.)><Central Nervous System><Cerebrospinal Fluid><Child><Child Youth><Childhood><Children (0-21)><Chronologic Fetal Maturity><Clinical><Collaborations><Congenital Syphilis><Data><Department of Health and Human Services><Detection><Development><Diagnosis><Diagnostic><Diagnostic tests><Disease><Disorder><Early Intervention><Enrollment><Evaluation><Exclusion><Exposure to><Fetal Age><Gestation><Gestational Age><Globus Pallidus><Guidelines><History><Hour><Individual><Infant><Infection><Interdisciplinary Research><Interdisciplinary Study><Intervention><Intervention Strategies><Lab Findings><Laboratory Finding><Lesion><Letters><Linear Regressions><Live Birth><Mann-Whitney U Test><Medical Inspection><Methods><Modality><Modernization><Molecular><Mucosa><Mucosal Tissue><Mucous Membrane><Multidisciplinary Collaboration><Multidisciplinary Research><Neonatal><Neural Development><Neuraxis><Newborn Infant><Newborns><Normal Placentoma><Nucleic Acid Amplification Tests><Nucleic Acid Testing><Outcome><Parturition><Pathogen detection><Patients><Perinatal><Peripartum><Physical Examination><Placenta><Placenta Embryonic Tissue><Placentome><Policies><Polymerase Chain Reaction><Postpartum Period><Pregnancy><Prevalence><Probability><Prospective cohort><Public Health><Recommendation><Recording of previous events><Regression Analyses><Regression Analysis><Regression Diagnostics><Research><Risk><Sample Size><Science><Seizures><Serodiagnoses><Serological Diagnosis><Serology test><Sexually Transmitted Diseases><Sexually Transmitted Disorder><Sexually Transmitted Infection><Side><Statistical Regression><Students><Swab><Symptoms><Syphilis><Syphilis Serodiagnosis><T pallidum><T. pallidum><Techniques><Test Result><Testing><Time><Toddler><Treatment Protocols><Treatment Regimen><Treatment Schedule><Treponema pallidum><United States Centers for Disease Control><United States Centers for Disease Control and Prevention><United States Department of Health and Human Services><United States Dept. of Health and Human Services><Urine><Venereal Diseases><Venereal Disorders><Venereal Infections><Woman><active followup><adulthood><adverse consequence><adverse outcome><cerebral spinal fluid><co-infection><cohort><coinfection><congenital infection><developmental><diagnostic algorithm><diagnostic serology><early childhood><enroll><follow up><follow-up><followed up><followup><great pox><head-to-head analysis><head-to-head comparison><healthcare burden><histories><improved><infected neonate><infected newborn><innovate><innovation><innovative><intervention program><interventional strategy><kids><neonatal infection><neonatal morbidity><neonate><neurodevelopment><new diagnostics><newborn child><newborn children><newborn infection><newborn morbidity><next generation diagnostics><novel><novel diagnostics><offspring><pallidum><pediatric><performance tests><physical examinations><post-partum><prevent><preventing><primary outcome><prospective><recruit><screening><screenings><serology assay><sex><sexually acquired infection><spinal fluid><syphilis test><transcription mediated amplification><youngster>