Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children I… (NCT01923636) | Clinical Trial Compass
CompletedNot Applicable
Prognostic Value of Neonatal Markers for the Development of Neurosensorial Sequelae in Children Infected by Cytomegalovirus in Utero
France254 participantsStarted 2013-09-09
Plain-language summary
The main objective of this study is to validate , in the neonatal period, a prognostic score for the development of neurosensorineural sequelae at 1 year and at 2 years in neonates infected in utero by cytomegalovirus. This score will be based on clinical, imaging and biological criteria .
The second objective of the study is to estimate the prevalence of this infection in France and to describe its epidemiology through the screening of 12,000 consecutive neonates.
Who can participate
Age range
1 Day – 1 Month
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Main objective: Neonate less than 1 month with congenital CMV infection at birth objectified by the detection of CMV in a urine sample, in saliva or blood (fresh or Guthrie card) obtained in the first 10 days life
* Whose parents accept regular monitoring by the paediatrician investigator
* For which a medical examination has been made
* Affiliated with a social security system
* And whose mother has given its written consent to the participation of their child to study
Exclusion Criteria:
\- Children participating in an interventional study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prognostic value of neonatal markers (clinical, imaging and biological) for the development of neurosensorial sequelae at 1 year of age