Development of Primer and Reference Tool to Assess Neonatal Abstinence Syndrome
This topic addresses the demand to promote awareness and knowledge of the best practice in management of Neonatal Abstinence Syndrome (NAS). The need is caused by clinical rigor and raised concerns among neonatal and pediatric practitioners regarding a constellation of various withdrawal symptoms and treatment approaches. The ultimate goal of this solicitation is to develop a skill-building Primer and Reference Tool to assist clinicians in identifying, interpretation, scoring and responding to NAS symptoms toward improving neonatal outcomes.
NAS is a group of withdrawal problems that occur in a newborn who was exposed to addictive drugs while in the mother?s womb. NAS characterized by gastrointestinal, respiratory, autonomic, and central nervous system disturbances from drug withdrawal that affect critical regulatory areas for postnatal life adaptation. Withdrawal signs may develop in 37% to 94% of neonates exposed by various addictive substances including illegal drugs or prescribed analgesics and antidepressants.
In the past decade, the use of prescription opioids and the incidence of opioid addiction among women of childbearing age increased substantially. According the American Academy of Pediatrics, the number of opioid-dependent NAS diagnoses increased threefold reaching more than 13,000 babies across the United States annually. Currently, the consistent use of pain relievers with other drugs become more common that causes the NAS symptoms to be more severe and poorly manageable. At the consequence, newborns with NAS present new challenges for the neonatal hospitals and may require prolonged hospitalization in order to alleviate the symptoms. The national health cost to care for such infants jumped from $190 million in 2000 to $720 million per year in 2009. In addition, there is the growing concern, that hospitals may discharge some newborns before the symptoms appearance, if newborns were exposed by long-acting opioids with five or more days to show signs of withdrawal. These newborns present the significant challenge for diagnostics at hospital emergency rooms or out-patient pediatric units outside of the nation?s epicenters of drug abuse.
To date, there is neither a standard diagnostic tool, preventive treatment strategy, nor a comprehensive educational program to manage NAS. Among educational resources, few existing online applications (Neonatal Drug Withdrawal Protocol App, Kaiser Permanente; Neonatal Abstinence Syndrome CE581, Nurse.com) are limited in the context and provide general text-based information with no interactivity rather than helping practitioners to adapt the clinical symptoms to the established diagnostic and treatment guidelines.
Responding to the demand for NAS awareness and medical care standardization, the National Institute on Drug Abuse (NIDA) supports development of a medical Primer and Reference Tool to specifically address the information gap in this critical pediatric health problem. With the long-term goal of improving neonatal health care, NIDA is soliciting proposals for a SBIR contract to develop and evaluate a bedside assisting App for NAS management.
Currently, the modified Neonatal Abstinence Scoring System (or Modified Finnegan Scoring system) is the predominant scoring tool used in the United States. Despite of its complexity and bulkiness as the 21-item related observation checklist, the Modified Finnegan Scoring remains more comprehensive system. The value of NAS severity, calculated by this tool, is a critical feature for any NAS assessment which serves as the basis for treatment selection and start. Recently, the Modified Finnegan Scoring was incorporated into the electronic medical record (EMR) platforms in the national centers of pediatric care excellence and the nation?s epicenters of drug abuse. However, outside the recognized medical centers, most nurses and pediatricians have little experience in NAS evaluation and Finnegan Scoring. These hospital codes are unfamiliar with the criteria of NAS and may give the neonatal an alternative diagnosis that shares signs with NAS such as infection, hypoglycemia, hypocalcemia, hyperthyroidism, intracranial hemorrhage, hypoxic-ischemic encephalopathy, and hyperviscosity. At presentation, signs of NAS vary and usually include excessive cry, irritability, short sleep, tremors, stiffened muscles, gastro-intestinal and respiratory problems. NAS unawareness or different practice standards cases the number of challenges in diagnostics and therapeutic strategies.
Thus, the lack of the standard management and bed-side references causes bias and subjectivity in NAS scoring and assessment. To address this problem, the new electronic tool should adapt and unify the existing knowledge regarding NAS risks, symptoms, Finnegan Scoring, diagnostic and therapeutic approaches. New tool is sought to better explain the withdrawal symptoms in newborns and provide bed-side instructions how to assess the Modified Finnegan Score. The primary target audience for the proposed tool includes neonatal practitioners, pediatricians, and nurses. However, the material are sought to be useful for a wide range of health care professionals from family or GYN physicians, pain prescription provides to medical and nurse students who wish to continue their medical carrier to pediatrics.
Phase I Activities and Expected Deliverables:
1. Assemble a consultant team and determine availability of data, references, educational and clinical guidelines, and presentation strategies. Offerors are expected to have in house capabilities or the established practice or experience to contact consultative and CME educational services, neonatal centers, hospitals, professional associations and medical practitioners including but not limited to neonatal providers, nurses, pediatricians, and pain prescription physicians.
2. Develop a curriculum for education modules and interactive resources. An electronic Tool should adapt the skill-building multimodal Primer and serve as a bed-site Reference Tool for neonatal and pediatric providers.
A Primer and Reference Tool proposed in response to this solicitation should provide the repository of necessary information in following areas:
a. Epidemiology and pathophysiology of NAS.
b. The clinical phenomenon of NAS symptoms. Clinical signs, frequency, severity and duration of NAS. Mechanisms of opioids withdraw. Clinical facts of multi-drug exposures and their impact to NAS development and representation.
c. Interpretation of the Modified Finnegan Score system. Guidelines in assessment and scoring.
d. Overview of available and appropriate toxicology tests to determine the exposure level. All drug screening procedures should contain corresponding references to the test sensitivity, efficiency, time for analysis, cost and diagnostic limitations.
e. Description of pharmacologic and non- pharmacologic interventions. Interactive referral and references how to select the appropriate therapy based on the symptoms appearance and NAS scoring. The materials should describe the importance of breastfeeding in stable mothers.
3. Define and collect all reference materials such as medical publications, scientific references, best-practice guidelines, and other downloadable tools. A Tool may be built with the option for interactive questions.
4. Identify an electronic platform for the software implementation. A Tool?s App should have full compatibility with both Flash and FULL compatibility with HTML5 standards.
5. Develop a detailed project plan for Phase II activities which includes, but is not limited to:
a. Project Gantt
b. Task linked budget for Phase II Activities
c. Mock Ups outlining of Phase I Deliverables 2 (a-e) and Description of the Software
d. Plan for the case study recording
e. Examples of surveys to be used in Phase II Activities
f. Plan for piloting, evaluation, and refinement of draft modules
g. Plan to address FDA-regulations if a Tool is to be disseminated as a NAS scoring and a clinical/treatment reference device w/wo compatibility with electronic medical records (EMR) software.
Phase I Activities and Expected Deliverables:
Develop a multimodal awareness building program of a Primer and Reference Tool:
a. Collect case presentations (video and descriptive) to supplement tool?s modules and address the challenges in NAS symptoms recognition and interpretation;
b. Create reliable software as required. Code the device as needed.
Conduct a Pilot study of the draft module with professionals representing the target audience to a Primer and Reference Tool. Conduct community?s feedback survey and analyze data.
Revise and improve software in response to perceived needs. Complete the web-based lesson context, iterative design and development of the software operation tools.
Conduct efficiency study and evaluate the effectiveness of a Primer and Reference Tool. Complete satisfaction and acceptance testing.
Prepare strategy for implementation and dissemination.
- Agency: Department of Health and Human Services,Department of Health and Human Services
- Program: SBIR
- Phase: Phase I
- Release Date: July 24, 2015
- Open Date: July 24, 2015
- Close Date: October 16, 2015
- URL: https://sbir.nih.gov/sites/default/files/PHS2016-1.pdf