Cytomegalovirus InfectionsCMVNCT02683096
Screening for Congenital Cytomegalovirus Infection in Newborns
An observational study of Cytomegalovirus Infections, run by Southern Illinois University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 10 days
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- Observation
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborn infants who either fail their newborn hearing test or have a diagnosis of small for gestational age (SGA)
Who may be able to join
- 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.
Who cannot join
- Infants born ≤ 27 weeks gestation, infants who are not SGA, infants who pass their newborn hearing screen.
About this study
Official title: Screening for Congenital Cytomegalovirus Infection in Newborns With Failed Hearing Screen or Who Are Small for Gestational Age
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.
Read the 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.
- Conditions
- Cytomegalovirus Infections
- Being tested
- Observation
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SGA Infants | Not described Receives: Other: Observation | |
| Failed Hearing Screen Infants | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the incidence of congenital CMV infection in neonates with failed hearing screen.
Measured: At birth
Measure the incidence of congenital CMV infection in neonates who are SGA.
Measured: At birth
Secondary outcomes (1)
Measure the proportion of patients that receive therapeutic intervention in 2 groups of patients with congenital CMV infection
Measured: First six months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Illinois University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Marcela Rodriguez, MD, Principal investigator, SIU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02683096
- Sponsor's protocol ID
- ROD-SIU-15-288-CMV
- Acronym
- CMV
- Status last verified
- May 2018
- First submitted
- 11 Feb 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Congenital Cytomegalovirus Infection in Newborns With Failed Hearing Screen or Who Are Small for Gestational Age
- ClinicalTrials.gov ID
- NCT02683096
- Acronym / sponsor ID
- CMV / ROD-SIU-15-288-CMV
- Conditions
- Cytomegalovirus Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Southern Illinois UniversityUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Feb 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 17 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGA Infants | – | Other: Observation |
| Failed Hearing Screen Infants | – | Other: Observation |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn infants who either fail their newborn hearing test or have a diagnosis of small for gestational age (SGA)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants born ≤ 27 weeks gestation, infants who are not SGA, infants who pass their newborn hearing screen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationViable 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. | Other | Failed Hearing Screen Infants, SGA Infants |
Primary outcome
Measure the incidence of congenital CMV infection in neonates with failed hearing screen.
Time frame: At birth
Measure the incidence of congenital CMV infection in neonates who are SGA.
Time frame: At birth
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Individual participant dataSharing planned: No
Related trials for Cytomegalovirus Infections
RecruitingObservational study
A Study of LIVTENCITY (Maribavir) in Adults With Cytomegalovirus (CMV) Infection After Transplantation in South Korea
Cytomegalovirus (CMV)
RecruitingObservational study
The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
EBV, HSV
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
CMV CTLs in Neonates With CMV Infection
Congenital Cytomegaloviral (CMV) Disease
RecruitingPhase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcela Rodriguez, MD principal investigator
SIU School of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections, run by Southern Illinois University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the incidence of congenital CMV infection in neonates with failed hearing screen. (time frame: At birth). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.