Key Dates
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National Heart, Lung, and Blood Institute (NHLBI)
The National Heart, Lung and Blood Institute (NHLBI) intends to promote a new initiative by publishing a Notice of Funding Opportunity (NOFO) which will support a consortium to phenotype 0-2 year old children with severe viral lower respiratory tract infections (LRTI) with follow up until pre-school age for pulmonary sequelae.This Notice of Intent to Publish (NOITP) is being provided to allow potential applicants sufficient time to develop responsive projects.
NHLBI intends to utilize the paired activity codes U24 to fund the Data and Analytics Co-ordinating Center (DACC) and the linked UG3/UH3 (Phased award with built-in milestones for transition) to fund one Clinical Coordinating Center (CCC) and Biorepository along with four Clinical Centers (CCs).
The anticipated project period of both awards is TBD, with a likely budget of up to $7.3 million in total costs to support the DACC (U24), up to $15 million in total costs to fund the CCC and Biorepository (UG3/UH3), and up to $9.3 million in total costs to support each of the four CCs.
The NOFOs are expected to be published in January 2025 with an anticipated application receipt date in June 2025. Funding decisions are anticipated in February 2026.
Viral and bacterial LRTI are leading causes of infant mortality worldwide, and are more severe in children less than two years of age. Viral LRTI cause bronchiolitis, pneumonia and the acute respiratory distress syndrome (ARDS) with greater than 100,000 hospitalizations annually and significant burden on patients, their families and the health care system. When these infections occur during a period of logarithmic growth and change, they inhibit the optimal growth and development of the lung and may impact future respiratory health, with the development of asthma and other conditions.
The intended NOFO will seek applications for building the VINYL (Viral Infections in the Young Lung) consortium with the goal of detailed clinical, molecular and immunological phenotyping of 1500 young children (0-2 years of age) hospitalized with LRTI in the in-patient setting. The cohort will be retained until pre-school age to evaluate pulmonary and other sequelae among the participants. The consortium will include a CCC, overseeing 4 additional clinical centers (CCs) and a biorepository; as well a DACC that will lead the building of a database, data analytics and training. The proposals must include the use of contemporaneous controls, either within the cohort, or by leveraging existing cohorts, aided by collaboration with existing networks. In addition, the NOFO will provide the opportunity to propose mechanistic sub-studies leveraging the core data and biospecimens to answer focused research questions. These could be observational and/or include basic experimental studies in humans, employing the cohort.
The proposed study design should be rigorous with scrupulous attention to harmonized data collection and ingestion across sites for the common protocol, creation of a timely, publicly-accessible database, and a detailed statistical analysis plan to phenotype the cohort that includes follow-up data obtained after hospital discharge.
Applicants will be required to propose a multidisciplinary research team that includes expertise in inpatient clinical and outcomes research, pediatric hospitalists, intensivists, pulmonologists, and neonatologists (when applicable) with appropriate scientific representation in data science, pediatric infectious diseases, immunology, genetics and molecular biology,
This Notice is being provided to encourage investigators with clinical insight and research interest in respiratory viral infections in hospitalized young children and their likely cardiopulmonary, neurocognitive and sleep sequelae, to begin to consider applying for these new anticipated NOFOs. The Notice will help to allow sufficient time for potential applicants to develop meaningful collaborations and responsive projects, given the multidisciplinary expertise involved and the wide variety of research questions that could be asked of this cohort.
The NOFOs are expected to be published in January 2025 with an anticipated application receipt date in June 2025.
NHLBI expects to utilize the paired activity codes UG3/UH3 (phased award with built-in milestones for transition) to fund one CCC and Biorepository, and four additional CCs, and the U24 activity code to fund one linked DACC.
Funding Information
TBD
TBD
93.838
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Inquiries
Aruna Natarajan, MD, PhD
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-827-0180
Email: [email protected]
and Human Services (HHS)
