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Trial record 7 of 296 for:    "Cytomegalic inclusion disease"

Screening for Congenital Cytomegalovirus Infection in Newborns (CMV)

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ClinicalTrials.gov Identifier: NCT02683096
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
University of Alabama at Birmingham
Information provided by (Responsible Party):
Southern Illinois University

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.

Condition or disease Intervention/treatment
Cytomegalovirus Infections Other: Observation

Detailed Description:

Congenital cytomegalovirus (CMV) infection is the leading non-genetic cause of sensorineural hearing loss (SNHL) in children in the United States, and is the most frequent known viral cause of mental disability. Approximately one percent of all newborn infants in the United States are infected with CMV. Of those infected, approximately 10% have involvement that is evident at birth (symptomatic congenital CMV disease) with manifestations including microcephaly, central nervous system abnormalities, chorioretinitis, hepatosplenomegaly, and SNHL. The most common sequelae following congenital CMV infection is SNHL and it occurs in up to 50% of infants with symptomatic congenital CMV infection and in 15% of asymptomatic infants. Overall, congenital CMV infection accounts for one-third of all cases of SNHL. Among newborn infants who fail hearing screening, the prevalence of congenital CMV infection is much higher (six to 10%) than the general newborn population (<1%). Since early therapeutic intervention for infants with symptomatic congenital CMV infections improves audiological and neurodevelopmental outcomes early diagnosis is essential for early treatment and maximizing infant outcomes.

The Illinois Legislature passed a bill that was signed into law in August 2015 by Governor Rauner regarding congenital CMV. The main objectives of this law are public education regarding CMV infection and efforts to raise awareness of this infection amongst healthcare providers caring for expectant mothers. This Public Act mandates parents receive information regarding testing opportunities and early intervention services for CMV infection when their newborn infant fails his or her hearing screen. Although this bill does not mandate CMV screening, it does state that the hospitals have to provide information about testing options.

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.


Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Screening for Congenital Cytomegalovirus Infection in Newborns With Failed Hearing Screen or Who Are Small for Gestational Age
Study Start Date : February 2016
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018


Group/Cohort Intervention/treatment
SGA Infants 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.

Failed Hearing Screen Infants 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.




Primary Outcome Measures :
  1. Measure the incidence of congenital CMV infection in neonates with failed hearing screen. [ Time Frame: At birth ]
  2. Measure the incidence of congenital CMV infection in neonates who are SGA. [ Time Frame: At birth ]

Secondary Outcome Measures :
  1. Measure the proportion of patients that receive therapeutic intervention in 2 groups of patients with congenital CMV infection [ Time Frame: First six months of life ]

Biospecimen Retention:   Samples Without DNA
saliva PCR assays


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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683096


Sponsors and Collaborators
Southern Illinois University
University of Alabama at Birmingham
Investigators
Principal Investigator: Marcela Rodriguez, MD SIU School of Medicine

Responsible Party: Southern Illinois University
ClinicalTrials.gov Identifier: NCT02683096     History of Changes
Other Study ID Numbers: ROD-SIU-15-288-CMV
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases