Viral INfections in the Young Lung- The VINYL Clinical Consortium- Data Analytics and Coordinating Center (DACC)(U24 Clinical Trial Optional) | RFA HL 26 008

FAQs: NIH RFA-HL-26-008 (VINYL Clinical Consortium Data Analytics and Coordinating Center)

What is RFA-HL-26-008 funding?

RFA-HL-26-008 is an NIH funding opportunity to support creation of the VINYL Clinical Consortium and, specifically, a Data Analytics and Coordinating Center (DACC). The award mechanism is a U24 cooperative agreement, and the clinical trial designation is listed as optional.

What is being built through this opportunity?

The goal is to build an organized, multi-site clinical research network that can enroll and study very young children who are hospitalized with severe viral lower respiratory tract infections (LRTIs), collect standardized clinical and biological data at scale, and follow participants over time to understand longer-term lung health outcomes.

What is the main purpose of the VINYL Clinical Consortium?

The consortium is designed to collect consistent, high-quality clinical and biological data from hospitalized young children with severe viral LRTIs and then track them longitudinally to learn how early-life severe viral illness influences later respiratory outcomes such as chronic lung disease and asthma.

Who are the patient participants this program focuses on?

The program focuses on babies, infants, and toddlers from birth through 2 years of age who are hospitalized with acute bronchiolitis, pneumonia, and/or pediatric acute respiratory distress syndrome (PARDS).

What conditions are included under the severe viral LRTI umbrella in this program?

The described hospitalized conditions include acute bronchiolitis, pneumonia, and PARDS in children from birth to age 2, all in the context of severe viral lower respiratory tract infection.

Why does the opportunity emphasize bronchiolitis?

The opportunity notes that bronchiolitis is unique to the young lung and is the leading cause of hospitalization for viral LRTI in children ages 0 to 2, including children born preterm.

What does "deep phenotyping" mean in this consortium?

The consortium aims to perform deep phenotyping on about 1,500 hospitalized children. While the notice does not list every variable, deep phenotyping in this context generally implies collecting detailed information beyond routine clinical documentation, such as careful characterization of clinical course and severity, detailed virology (which virus or viruses are involved), host factors (including immune response features), and other risk modifiers like prematurity.

How many children are expected to be deeply phenotyped?

About 1,500 hospitalized children are expected to undergo deep phenotyping as described in the opportunity summary.

What scientific gaps is the consortium meant to address?

The consortium is designed to address major gaps in how bronchiolitis and related viral LRTIs are defined, how severity can be predicted early, and why hospitalization occurs in some children but not others. It also aims to help explain why children may respond differently depending on the virus and the maturity of the infant immune system during the first two years of life.

Why is standardization across sites important for this program?

The opportunity highlights significant practice variation in diagnosis and management across hospitals. A coordinated consortium with standardized approaches is intended to reduce inconsistencies, make outcomes more comparable, and clarify what drives differences in severity, recovery, and longer-term lung health.

What longer-term outcomes will the consortium assess?

A major component is longitudinal follow-up to determine later respiratory outcomes, including signs of chronic lung disease and asthma, when participants reach about 4 to 5 years of age.

At what age are children followed up for longer-term respiratory outcomes?

The opportunity describes follow-up to around age 4 to 5 years to assess longer-term respiratory outcomes.

Why is longitudinal follow-up a major component?

The program reflects long-standing concerns that severe bronchiolitis and other early-life viral LRTIs can be associated with later wheezing disorders and asthma, while recognizing that pathways, subtypes, and predictors are still not well understood. Following children over time helps link early hospitalization features to later outcomes.

What is the DACC in the VINYL Clinical Consortium?

DACC stands for Data Analytics and Coordinating Center. In practical terms, it serves as the backbone for data coordination and analytics across the multi-site clinical consortium.

What kinds of responsibilities are implied for the DACC?

Based on the description, the DACC role typically includes building or managing shared data systems across sites, supporting consistent data collection and quality control, coordinating data harmonization and documentation, supporting statistical and computational analyses, and helping maintain the infrastructure needed for long-term follow-up.

Why is a coordinating center especially important for this population?

Because the consortium involves enrolling very young hospitalized children and tracking outcomes years later, coordinating center functions are central to maintaining standardized procedures, minimizing missing data, and producing analyzable datasets that can support robust conclusions about disease mechanisms, severity prediction, and long-term respiratory risk.

What award mechanism is used for this opportunity?

The opportunity uses a U24 cooperative agreement mechanism.

What does a cooperative agreement imply compared with a standard research grant?

The summary notes that a cooperative agreement usually means NIH staff will have substantial programmatic involvement compared with a standard research grant.

Is a clinical trial required under this opportunity?

The listing indicates "clinical trial optional," meaning a clinical trial is not necessarily required as part of the proposed work, based on the provided information.

What is the CFDA number and NIH category mentioned?

The opportunity is described as a discretionary NIH opportunity in the health category with CFDA 93.838.

When was this opportunity created?

The opportunity was created on 2025-09-18.

What is the original closing date?

The posted original closing date is 2025-11-10.

How many awards will NIH make and what is the award ceiling?

The expected number of awards and the award ceiling are not specified in the provided listing. Applicants would need to consult the full announcement for budget expectations and related details.

Who is eligible to apply?

Eligibility is broad and includes many U.S.-based public and private entities, including: state, county, and local governments; special districts; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other eligible organizations.

Are U.S. territories and regional organizations eligible?

Yes. The notice mentions additional eligible applicant types including regional organizations and U.S. territories or possessions.

Are faith-based or community-based organizations eligible?

Yes. The notice explicitly mentions faith-based or community-based organizations among additional eligible applicant types.

Can federal agencies apply?

The notice mentions eligible federal agencies as an eligible applicant type.

Are foreign organizations eligible to apply as the applicant?

No. Foreign organizations (non-U.S. entities) are not eligible to apply as applicant organizations based on the provided information.

Can a U.S. organization include non-U.S. components or foreign components?

Yes. The summary states that non-U.S. components of U.S. organizations are allowed, and foreign components (as defined in NIH policy) are permitted. This can matter for specialized analyses, assays, or collaborations that require unique expertise or resources outside the U.S.

What is the overall research strategy this consortium enables?

The consortium model is intended to generate harmonized data across multiple sites so researchers can sort out heterogeneity, identify meaningful subgroups, and link early hospitalization features (including severity and virology) to later respiratory outcomes.

Does the opportunity list the exact data elements to be collected?

No. The description notes that the notice does not list every variable, even though it emphasizes consistent, high-quality clinical and biological data and deep phenotyping.

What types of factors might be examined to explain why some children become very sick?

The summary points to host factors, including immune response features, as well as other risk modifiers such as prematurity, and it highlights that responses may differ depending on the virus and the maturity of the infant immune system.

What practical problem does the consortium address in real-world hospital care?

It addresses practice variation across hospitals in diagnosis and management of bronchiolitis and related viral LRTIs, which can make comparisons difficult and obscure what drives differences in severity and recovery.

Where can applicants find budget expectations, consortium structure, and detailed DACC responsibilities?

The summary indicates those details are not fully specified in the provided listing and that applicants would need to consult the full funding announcement for budget expectations, consortium structure, and detailed DACC responsibilities.