Prospective Observational Study of Asymptomatic cCMV Transmission to Infants for Virological Evaluation in New York State
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Congenital CMV infection rate
研究概览
简要总结
PROACTIVE NYS is a long-term follow-up study of all infants who test positive for congenital Cytomegalovirus infection (CMV) throughout New York State on the Newborn Screen. By following all infants who screen positive, we will learn important information about the range of symptoms caused by congenital CMV, from those babies with more severe findings to those with no symptoms.
In particular, our study will provide new information about many facets of congenital CMV, including:
- Developmental, hearing, neurologic, and vision outcomes
- The spectrum and timing of symptoms
- The impact congenital CMV has on the baby and its family
- How many babies are infected with congenital CMV in New York State How antiviral medications and other interventions impact outcomes of children with congenital CMV
Throughout the duration of the study, children will undergo routine developmental and hearing assessments, which will assist with early diagnosis of any infection complications.
Any child found to have a neurodevelopmental, hearing, or vision abnormality will be referred for appropriate evaluation and treatment.
Families will also be asked to complete periodic surveys about their experience with congenital CMV, both as a medical diagnosis and as it affects their day-to-day activities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates born in New York State during cCMV NBS Pilot Program (September 27, 2023 - October 1, 2024)
- •cCMV evaluation provided by a designated NYS cCMV clinical referral site
- •Family willing and able to complete all study procedures
- •Study participants meet criteria for one of the following four categories:
- •Category 1 (Confirmed cCMV identified by NBS Program): cCMV NYS newborn screen positive AND cCMV confirmatory test positive
- •Category 2 (Confirmed cCMV not identified by NBS Program): cCMV NYS newborn screen negative AND cCMV confirmatory test positive
- •Category 3 (False-positive cCMV screen): cCMV NYS newborn screen positive AND negative cCMV confirmatory test
- •Category 4 (Premature infants with confirmed CMV infection on late positive NBS): Infant born prior to 37 weeks gestation AND cCMV positive on any NYS newborn screen collected prior to 44 weeks gestational age AND Positive cCMV confirmatory test obtained within 14 days of a positive NBS
排除标准
- •Neonate whose parents refuse participation in the long-term follow-up study
结局指标
主要结局
Congenital CMV infection rate
时间窗: Study initiation to 1 year time point
To determine the rate of confirmed congenital CMV in a statewide cohort
次要结局
- cCMV neonatal sensorineural hearing loss(Through 4 weeks old)
- cCMV antiviral therapy utilization(2 years)
- cCMV acquired sensorineural hearing loss(2 years)
- cCMV-related quality of life(2 years)
- cCMV neurodevelopmental outcomes(2 years)
研究者
Andrew S Handel
Physician
Stony Brook University