Screening for Congenital Cytomegalovirus Infection in Newborns

NCT02683096 | Completed

• 1 other identifier: ROD-SIU-15-288-CMV
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Measure the incidence of congenital CMV infection in neonates with failed hearing screen.

  At birth

• Measure the incidence of congenital CMV infection in neonates who are SGA.

  At birth

Secondary Outcomes (1)

• Measure the proportion of patients that receive therapeutic intervention in 2 groups of patients with congenital CMV infection

  First six months of life

Study Arms (2)

SGA Infants

Other: Observation

Failed Hearing Screen Infants

Other: Observation

Interventions

Observation OTHER

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.

Failed Hearing Screen Infants; SGA Infants

Eligibility Criteria

• Age: Up to 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Newborn infants who either fail their newborn hearing test or have a diagnosis of small for gestational age (SGA)

You may qualify if:

• 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.

You may not qualify if:

• Infants born ≤ 27 weeks gestation, infants who are not SGA, infants who pass their newborn hearing screen.

Sponsors & Collaborators

• Southern Illinois University: lead
• University of Alabama at Birmingham: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

saliva PCR assays

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Observation

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Marcela Rodriguez, MD

  SIU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 17, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share