NOT-HD-23-022: Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Limited Competition: Clinical Centers for Completion of the Outcomes of Babies with Opioid Exposure (OBOE) Study (UG1 Clinical Trial Not Allowed)

Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Limited Competition: Clinical Centers for Completion of the Outcomes of Babies with Opioid Exposure (OBOE) Study (UG1 Clinical Trial Not Allowed)

Notice Number:

NOT-HD-23-022

Key Dates

Release Date:

July 19, 2023

Estimated Publication Date of Notice of Funding Opportunity :

August 31, 2023

First Estimated Application Due Date:

November 15, 2023

Earliest Estimated Award Date:

July 01, 2024

Earliest Estimated Start Date:

July 01, 2024

Related Announcements

July 19, 2023 - Notice of Intent to Publish a Funding Opportunity Announcement for HEAL Initiative: Limited Competition: Data Coordinating Center for Completion of the Outcomes of Babies with Opioid Exposure (OBOE) Study (U24 Clinical Trial Not Allowed). See Notice NOT-HD-23-023.

December 10, 2018 - HEAL Initiative: Antenatal Opioid Exposure Longitudinal Study Consortium (PL1 Clinical Trial Not Allowed). See NOFO RFA-HD-19-025.

Issued by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Purpose

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to issue a Notice of Funding Opportunity (NOFO) for a limited re-competition of the Outcomes of Babies with Opioid Exposure (OBOE) Clinical Centers to complete OBOE's ongoing studies.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The NOFO is expected to be published in late Summer 2023 with an expected application due date in late Fall 2023.

This NOFO will utilize the UG1 activity code. Details of the planned NOFO are provided below.

Research Initiative Details

Among infants covered by Medicaid in 46 states, from 2004 to 2014 the incidence of neonatal opioid withdrawal syndrome (NOWS) increased from 2.8 to 14.0 cases per 1000 hospital births. The Healthcare Cost and Utilization Project (HCUP) 2020 data estimated that six newborns were diagnosed with NOWS for every 1,000 newborns – approximately one baby diagnosed with NOWS every 24 minutes in the United States. Infants with NOWS may experience: tremors, irritability, sleep problems, hyperactive reflexes, seizures, stuffy nose/sneezing, poor feeding and sucking, vomiting, loose stools, dehydration, and increased sweating (https://www.cdc.gov/pregnancy/opioids/basics.html). NOWS also puts these children at increased risk of adverse neurodevelopmental outcomes.

The NIH Helping to End Addiction Long-term (HEAL) Initiative is working to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to: (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management. More information about the HEAL Initiative is available at: https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.

As part of the NIH HEAL Initiative, the purpose of NICHD’s OBOE consortium is to study the effects of antenatal opioid exposure on the trajectory of brain development over the first 2 years of life to better understand the long-term impacts of antenatal opioid exposure and NOWS. It will investigate associations between developmental and neurobehavioral outcomes and explore how specific factors (differing antenatal and postnatal exposures, severity of neonatal opioid withdrawal, maternal stress/depression/parenting) modify these effects. Such research is needed to inform development of appropriate care practices and treatments that would benefit exposed infants.

The objective of OBOE is for awardees to work together as a Consortium to implement a multi-site observational, prospective cohort study with multi-modal assessments of infants exposed to opioids in utero compared to unexposed infants from birth to two years of age to better understand the consequences of in utero opioid exposure. Participants will be assessed at 2-years of age with serial measures including neuroimaging, medical, neurodevelopmental, behavioral, and home, social, and family life assessments. The program will compare neuroanatomical (as measured by serial neuroimaging studies), medical, neurodevelopmental, behavioral, and home, social, and family outcomes between children who have been exposed to opioids in utero and those who have not been exposed.

This Notice encourages current OBOE awardees to apply to the planned NOFO to complete the ongoing studies.

Funding Information

Estimated Total Funding

TBD

Expected Number of Awards

Four (4)

Estimated Award Ceiling

TBD

Primary Assistance Listing Number(s)

TBD

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
For-Profit Organization (Other than Small Business)

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Nahida Chakhtoura, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6872
Email: Nahida.Chakhtoura@nih.gov