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Screening for Congenital Cytomegalovirus Infection in Newborns

NCT02683096 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2018-05-08

No results posted yet for this study

Summary

Our central hypothesis is that screening newborn infants who either fail their newborn hearing test or have a diagnosis of small for gestational age (SGA) will lead to better identification of infants with congenital CMV infection and enhanced rates of therapeutic intervention. This has the potential to significantly improve outcomes for infants with this common viral infection. This particular cohort of patients have not been well studied locally or regionally. In addition, in view of current legislation that will be effective in January, 2016 this is a timely project that will provide preliminary data for future statewide recommendations around CMV testing of newborn infants. This will be a pilot/feasibility study to obtain preliminary data for an Illinois Department of Public Health (IDPH) Title V grant. Although not guaranteed, preliminary discussions with the IDPH are highly encouraging giving the statewide interest in this topic.

Conditions

  • Cytomegalovirus Infections

Interventions

OTHER

Observation

Viable Infants with a failed hearing screen or a diagnosis of SGA who are born at either St. John's Hospital or MMC at ≥ 28 weeks gestation.

Sponsors & Collaborators

  • University of Alabama at Birmingham

    collaborator OTHER

  • Southern Illinois University

    lead OTHER

Principal Investigators

  • Marcela Rodriguez, MD · SIU School of Medicine

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-28
Completion
2018-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02683096 on ClinicalTrials.gov