NICHD – Patient Safety in the Context of Perinatal, Neonatal, and Pediatric Care (R01, R03 – Clinical Trial Optional)

May 25, 2018 by School of Medicine Webmaster

The following description was taken from the R01 version of this re-issued FOA.

This FOA encourages a wide range of collaborative research projects related to patient safety in the context of perinatal, neonatal and pediatric care both in routine hospital settings and in intensive care units. The FOA welcomes applications related to (but not limited to): the epidemiology of various domains of medical errors and consequent patient harm; assessing the factors at various levels that contribute to such errors; and intervention strategies at individual, systems, and institutional-levels to help reduce and eliminate medical errors. It is anticipated that knowledge gained from these projects will help develop strategies to deliver highest quality of healthcare to all newborn infants and children with utmost safety and effectiveness.


The seminal Agency for Healthcare Research and Quality (AHRQ) Making Health Care Safer report, issued in 2001, was the first effort to use evidence-based medicine principles in identifying practices to improve patient safety. Since the publication of this report, patient safety issues have received more attention from the scientific community and regulatory agencies. The US Food and Drug Administration has systems for reporting medication errors and healthcare device-related errors. Some of examples of progress in patient safety include the World Health Organization (WHO) surgical safety checklists care bundles which have been shown to reduce healthcare-associated infections and childbirth injuries, as well as extreme honesty, and increase in other transparent approaches for disclosures of errors.  Over the past decade, some patient safety practices have resulted in unintended consequences, whereas others have been shown to be highly context dependent, working effectively in a research setting but failing ding broader implementation.

In recognition of these unique challenges, NICHD held a workshop in 2010 to address knowledge gaps and to propose a research agenda on patient safety issues in neonatal intensive care units. Since that time, two program announcements have been published to stimulate the field and catalyze investigations and inquiries to fill the knowledge and practice gaps identified from the workshop.

In 2017, the American Academy of Pediatrics Committee on Pediatric Research listed improvement of systems of care which can mitigate medical errors as a high research priority for future advancements in child health. According to researchers at Johns Hopkins, over a quarter of a million deaths still occur each year because of health care related safety issues and account for a third of the deaths in this population overall.  Although many generic patient safety issues are applicable to neonatology and pediatrics, some unique aspects of patient safety in the neonatal intensive care unit have been recognized. These issues require specific and tailored research strategies.

A high priority of the Pregnancy and Perinatology Branch is to conduct research which increases infant survival free from disease and disability alongside the institute’s mission of ensuring that “all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability”. This announcement is meant to encourage extended research ideas that build on the momentum of investigators committed to developing research that will guide strategies to improve care to neonates by the most safe and effective means possible.

Unique Patient Safety Issues in Neonatal and Pediatric Care

Because of their small size and fragility, and their immaturity of organ systems, newborn infants are uniquely vulnerable to injury from even minor deviations in safe care practices.  Sick newborn infants in the neonatal intensive care units (NICU) are likely to be monitored using a large array of instruments. They are also likely to receive complex levels of care, which can include receiving several medications, undergoing invasive procedures for monitoring, and diagnosis and treatment over extended periods of hospitalization. There is also a possibility for receiving care from a team of experts.  All of the above factors tend to increase the potential for errors and patient harm.  There is also a narrow margin of safety; the patients are more likely to suffer from harmful consequences of errors sooner. Because of their unique vulnerability, even minor errors can lead to devastating short- and long-term consequences. In large general hospitals, patient safety efforts are likely to be targeted toward adult patients or treatment units, with little appreciation for the unique needs of the pediatric and neonatal units and their patients.

Other identified reasons for increased risk for medical errors in the context of neonatal care include unfavorable working conditions, healthcare provider fatigue, and a large array of treatment and investigative modalities needed for the care of high-risk newborn infants (e.g., ventilator, central catheter, medications, bed-side tests).  Additionally, there is paucity of well-tested, safe and effective devices and instruments for use specifically in the NICU.  Research to develop devices for use in the NICU is needed.

Several domains of errors and patient harm have been identified in the context of neonatal care.   These include:  medication errors; errors in administration of intravenous parenteral nutrition; delivery room resuscitation-related errors, ventilator care-related errors; error and harm from invasive procedures, health care–associated infections; patient identification errors; and diagnostic errors.  Other unique types of errors in the NICU include: feeding of the human milk to an infant from a wrong mother, inadvertent administration of human milk intravenously; or discharging an infant to the wrong family.


Research in the field of patient safety during neonatal care is challenging, with many dimensions that may require expertise from different fields.  Through this FOA, NIH encourages applications that address a variety of issues in the context of neonatal care. The field and scope of the research proposals sought include, but are not limited to:

Epidemiology of errors and adverse events in the setting of neonatal intensive care

  • Develop prospective and retrospective study designs to collect data on patient safety and adverse events (in collaboration with existing, or new PSOs with well-defined outcome measures and triggers); attempt to include such data from multiple levels, including community hospitals, pediatric and obstetric practices.
  • Study the strengths and limitations of current methods of error reporting systems.
  • Study the best practices and surveillance methods, and determine what adverse events need to be monitored, and how often.
  • Study the role of information technology, electronic health records in reducing medical errors.

Medication errors

  • Define the best processes and develop the safest distribution models for medications in the NICUs.
  • Develop proper instrumentations (small-volume syringes, tubing etc.), dosage calculation packages (taking into account changing weight and maturation).
  • Research on medication compatibility used with total parenteral nutrition.
  • Assess optimal space, personnel, and other logistics at the pharmacy preparing medications for use in the neonatal intensive care.
  • Study the effects of simple alterations in practice on patient safety such as:  color-coded line tubing, or line connectors to distinguish TPN solutions from human breast milk and large color-coded symbols to identify specific equipment and their storage sites.
  • Studies of drugs causing toxicity at standard doses among premature infants.

Diagnostic errors

      • Assess the effects of timeliness and precision (completeness) of diagnoses on outcomes, and assess factors contributing such errors.
      • Errors from patient misidentification.
      • Study the value of improved bar-coding system in proper patient identification.
      • Develop better IDs (non-invasive or minimally invasive systems).
      • Develop biomarkers as unique patient identifiers.

Procedure-related errors

  • Test the value of simulations in training for performing invasive procedures
  • Develop and test various “bundles” of care in reducing adverse events
  • Test the value of newer imaging methods to reduce procedure-related complications

Human factor and fatigue

  • Study the effect of reduction of work-hour of trainees in the NICU on patient safety, and how such measures impact the schedules of others, such as the attending physicians and the nursing staff
  • Study whether   genetic predispositions and sleep disorders among health care staff contribute to human error and fatigue
  • Utilize comparative effectiveness research strategies to assess appropriate work hour reduction to improve patient safety.
  • Study the effects of physician and nurse workload (e.g., optimal healthcare worker-to-patient ratio) on performance and patient safety.

Promotion of a safety culture

  • Testing procedures and processes that enhance safety in the NICU including but not limited to proper patient identification, sample handling, and individual patient breast milk identification.
  • Testing processes that promote adoption of safe practices by families and hospital staff.
  • Study the effects of teamwork training and leadership involvement in developing a culture of safety culture.

Other working conditions and systems issues

  • Study the effects of NICU architecture and other systems designs and environmental factors on performance and patient safety including the impact of sound and noise.
  • Develop a system to learn from ongoing evaluation of patient error and adverse event analyses to improve delivery of healthcare.
  • Assess the role of electronic and mechanical learning modules to enhance education on patient safety (e.g., training in invasive procedures, resuscitation, and setting up mechanical ventilators).
  • Determine the training models that best promote safety and improve quality.

Risk reduction and disclosure practices

  • Develop and test institution-wide practices for meaningful disclosures of medical errors and injuries to patient and the staff and demonstrate their effect.
  • Propose research to tackle the problem of “medical literacy”, such that locally-specific approaches are available for communicating errors and adverse events to the family fully and clearly.

Deadlines:  standard dates and standard AIDS dates apply (letters of intent due 30 days prior to the deadline)


Filed Under: Funding Opportunities