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9/08/2025  |   2:00 PM - 3:00 PM   |  Breakout 2   |  Memorial Hall

PROACTIVE NYS: Preliminary Results and Lessons Learned from a Longitudinal Study of Children with Congenital CMV in New York State

Abstract Summary

Background: Long-term outcomes of children with congenital CMV (cCMV), particularly those with clinically inapparent infections, remain incompletely described. The New York State Newborn Screening Program (NBS) conducted a one-year universal cCMV screening of 206,725 infants from 2023 – 2024. Children identified during screening were invited to enroll in a longitudinal follow-up study, PROACTIVE NYS. Objectives: (1) To describe preliminary findings of infants enrolled in PROACTIVE NYS and (2) to describe challenges and solutions in conducting a longitudinal cCMV study. Methods: Infants detected by NBS or through routine clinical care underwent diagnosis and management at a cCMV referral site. We enrolled infants meeting one of the following criteria: (1) confirmed cCMV initially identified by NBS, (2) false-negative cCMV NBS, (3) false-positive cCMV NBS, and (4) premature infants with postnatal cCMV acquired before 44 weeks gestation. Long-term planned measures include audiological, neurodevelopmental, ophthalmological, and quality of life evaluations at two years old. Results: NBS detected cCMV in 525 infants, including 277 with confirmed cCMV. 104 have been enrolled in PROACTIVE NYS, including 95 with cCMV identified by NBS, four with false-negative and one with false-positive cCMV NBS, and four premature infants with postnatal cCMV. Of 99 infants with confirmed cCMV, 45 (45%) had an abnormality identified on newborn evaluation, including 21 (21%) with one symptom, 12 (12%) with two, and 12 (12%) with three or more. Challenges have included maximizing enrollment, particularly for clinically inapparent cases, determining relatedness of abnormalities to cCMV, and ensuring follow-up assessment completion. Use of electronic and virtual enrollment tools improves study engagement. Discussion: Universal cCMV screening frequently identifies children with subtle abnormalities, who would likely go undiagnosed by hearing- and symptom-based screening. Implications of these mild findings remain unknown. Reducing logistical burdens placed on enrolled participants through use of electronic tools may improve clinical follow-up and study completion rates.

Learning Objectives

  • To characterize the preliminary findings of a longitudinal study of infants with congenital CMV identified through a universal screening program
  • To describe the challenges of conducting a multicenter longitudinal study of infants with congenital CMV
  • To discuss potential solutions for maximizing participant enrollment and retention

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Presenters


Andrew Handel | Primary Presenter, Author

Andrew.handel@stonybrookmedicine.edu;
Andrew Handel, MD, FAAP, is an Assistant Professor of Pediatrics in the division of Infectious Diseases at the Renaissance School of Medicine at Stony Brook University. He is a co-Primary Investigator of PROACTIVE NYS, a longitudinal study of children with congenital CMV in New York State.

ASHA DISCLOSURE

Financial - Receives Grants for Other activities from Eunice Kennedy Shriver National Institute of Child Health and Human Development.  

Nonfinancial - No relevant nonfinancial relationship exists.

AAA DISCLOSURE

Financial - Receives support from Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) for Research funding (75N94021D00018 / 75N94022F0000).  


Christine Salvatore | Author, Co-Author

chs2032@med.cornell.edu;
Christine Salvatore, MD, is a physician specializing in pediatric infectious diseases and serves as a site Primary Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Minnie John | Author, Co-Author

mij9037@nyp.org;
Minnie John, MD, is a physician specializing in pediatric infectious diseases and serves as a site Primary Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Mark Hicar | Author, Co-Author

mhicar@upa.chob.edu;
Mark Hicar, MD, PhD, is a physician specializing in pediatric infectious diseases and serves as a site Primary Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Gitanjali Rebello | Author, Co-Author

grebello@upa.chob.edu;
Gitanjali Rebello, MD, is a physician specializing in pediatric infectious diseases and serves as a site co-Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Sunil Sood | Author, Co-Author

ssood@northwell.edu;
Dr. Sood is a practicing Pediatric Infectious Disease physician and a Professor of Pediatrics. He is an investigator in several NIH-sponsored trials for treatment and follow-up of babies with congenital CMV. His current research focuses on improving recognition and treatment of congenital infections including CMV, Zika and toxoplasmosis. One of his primary goals to increase awareness of these infections among obstetricians and among women of child-bearing age.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Sheila Nolan | Author, Co-Author

Sheila_Nolan@bchphysicians.org;
Sheila Nolan, MD, is a physician specializing in pediatric infectious diseases and serves as a site Primary Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Patricia DeLaMora | Author, Co-Author

Patricia_DeLaMora@bchphysicians.org;
Patricia DeLaMora, MD, is a physician specializing in pediatric infectious diseases and serves as a site co-Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Danielle Daniels | Author, Co-Author

DanieDan@upstate.edu;
Danielle Daniels, MD, is a physician specializing in pediatric infectious diseases and serves as a site Primary Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Leonard Weiner | Author, Co-Author

weinerl@upstate.edu;
Leonard Weiner, MD, is a physician specializing in pediatric infectious diseases and serves as a site co-Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Gillian Taormina | Author, Co-Author

taormig@amc.edu;
Gillian Taormina, DO, is a physician specializing in pediatric infectious diseases and serves as a site Primary Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Jency Daniel | Author, Co-Author

danielj7@amc.edu;
Jency Daniel, MD, is a physician specializing in pediatric infectious diseases and serves as a site co-Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Saul Hymes | Author, Co-Author

hymess@amc.edu;
Saul Hymes, MD, is a physician specializing in pediatric infectious diseases and serves as a site co-Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Michael Quinn | Author, Co-Author

michael_quinn@urmc.rochester.edu;
Michael Quinn, MD, PhD, is a physician specializing in pediatric infectious diseases and serves as a site Primary Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Jennifer Nayak | Author, Co-Author

Jennifer_Nayak@URMC.Rochester.edu;
Jennifer Nayak, MD, is a physician specializing in pediatric infectious diseases and serves as a site co-Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Geoffrey Weinberg | Author, Co-Author

geoff_weinberg@urmc.rochester.edu;
Geoffrey Weinberg, MD, is a physician specializing in pediatric infectious diseases and serves as a site co-Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Julia Piwoz | Author, Co-Author

jpiwoz@montefiore.org;
Julia Piwoz, MD, is a physician specializing in pediatric infectious diseases and serves as a site Primary Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Stephanie Ungar | Author, Co-Author

Stephanie.Ungar@nyulangone.org;
Stephanie Ungar, MD, is a physician specializing in pediatric infectious diseases and serves as a site Primary Investigator for PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Norma Tavakoli | Author, Co-Author

norma.tavakoli@health.ny.gov;
Norma Tavakoli, Ph.D. received a Bachelor of Science degree in Microbiology and a doctoral degree in Molecular Biology from the University of Bristol, UK. Her postdoctoral research at the Wadsworth Center involved investigating transposable elements in bacteria. As the Director of Molecular Methods Development in the Clinical Virology Program at the Wadsworth Center, Dr. Tavakoli developed molecular assays for the detection of viral pathogens and was involved in outbreak response. She became the Director of the Viral Encephalitis Laboratory in 2004. Dr. Tavakoli joined the Newborn Screening Program in 2007 and has overseen the Immunoassay Laboratory since 2010. Her laboratory performs screening for congenital hypothyroidism, congenital adrenal hyperplasia, cystic fibrosis and HIV and recently performed a 1-year pilot study to screen newborns for congenital cytomegalovirus. She has worked as a consultant for the Association of Public Health Laboratories and is an Assistant Professor at State University of NY, Albany.

ASHA DISCLOSURE

Financial - No relevant financial relationship exists.

Nonfinancial - No relevant nonfinancial relationship exists.

AAA DISCLOSURE

Financial - No relevant financial relationship exists.


Sharon Nachman | Author, Co-Author

sharon.nachman@stonybrookmedicine.edu;
Sharon Nachman, MD is a SUNY Distinguished Professor of Pediatrics, Associate Dean of Research, Division Chief of Pediatric Infectious Diseases, and Chair of the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network. She serves as co-Primary Investigator of PROACTIVE NYS.

ASHA DISCLOSURE

Financial -

Nonfinancial -

AAA DISCLOSURE

Financial - No relevant financial relationship exists.