A NEW GLOBAL INITIATIVE: THE INTERNATIONAL NEONATAL CONSORTIUM
The National Association of Neonatal Nurses (NANN) has engaged in a new collaboration in 2015 with a global organization to advocate for the patients we are committed to serve-neonates.
National Association of Neonatal Nurses's partnership with the recently launched "International Neonatal Consortium (INC)" began in May 2015, after a representative from NANN participated in the INC's launch meeting held at the European Medicines Agency in London, United Kingdom. International Neonatal Consortium was convened under the leadership of Critical Path Institute, a nonprofit organization that was established in 2005 to support the US Food and Drug Administration's Critical Path Initiative program.1,2
Neonates are the patient population most frequently exposed to understudied therapies, as evidenced by one report noting that those born before 28 weeks' gestation are exposed to 12 unapproved drugs while in the neonatal intensive care unit.3 This means that they receive medications or therapies that have not been fully studied to establish safety or efficacy in the neonatal population. Another study demonstrated that 93% of hospitalized neonates were exposed to at least 1 off-label medication during their stay.4 Another study reports that extremely preterm neonates are exposed to more than 60 different medications during the hospitalization.5 National Association of Neonatal Nurses members are keenly aware of the therapeutic predicament that our patients and their families are placed in.
The global neonatal community is aware that targeted development of new therapies for the neonatal population has been overlooked for decades. Very few innovations have been marketed that have a positive impact on the outcomes of neonatal specific conditions since the introduction of surfactant and antenatal steroids.6
Although some have previously argued that there are significant ethical challenges when conducting clinical studies in the neonatal population, today, it is considered to be unethical to expose neonates to understudied therapies.2 Development of new drug therapies demands a highly complex process requiring coordinated collaboration across all stakeholders. Prior to the generation of clinical efficacy and safety data, extensive preclinical testing and clinical pharmacology studies must be completed. The unique physiology of our fragile population further complicates this process, which has led to stagnation of the neonatal drug development process.
International Neonatal Consortium was formed with a mission to specifically address these critical needs by combining resources from stakeholder groups worldwide, including such regulatory bodies as the Food and Drug Administration or European Medicines Agency, pharmaceutical industry partners, academic leaders in neonatal research, international neonatal research networks from multiple continents, funding organizations, special interest groups, parent organizations, and neonatal nursing organizations. The value of the voice of neonatal nurses was evident in INC's invitation for NANN to participate in this initiative. National Association of Neonatal Nurses and the Council of International Neonatal Nurses are the 2 nursing organizations actively involved with INC to represent the voice of neonatal nurses.
Recently, Senate bill S. 2041, "Promoting Life-Saving New Therapies for Neonates Act of 2015" was introduced.7 This bill supports INC's commitment and purpose to advocate the development of new treatments specifically for the neonates. While previous policy initiatives have led to numerous drug products being labeled to include pediatric information, they did not sufficiently address the needs of the neonatal population.8,9 The Senate bill is designed to stimulate neonatal therapy development to drive additional improvements in newborn health outcomes. It is the intention of the bill's sponsor to provide a unique incentive to expand the ability of industry partners to develop new therapies specifically for the neonatal population.
The new partnership with INC has allowed NANN to engage with this advocacy effort immediately. National Association of Neonatal Nurses was able to share the voice of neonatal nurses across congressional offices in Washington, District of Columbia, by drafting a letter of support describing our commitment to the newborns, who truly need the "lifesaving therapies."
National Association of Neonatal Nurses' representative to INC believes that the INC launch marked a significant point in history for the global neonatal community. International Neonatal Consortium is not simply a scientific community that will stimulate research but an entity with extensive involvement of a wide range of partners including the families and the nurses who stand by our vulnerable neonates. The ultimate mission of INC is to bring families, nurses, researchers, regulatory agencies, and other stakeholders closer together so that we can reduce perceived barriers to collaboration, share expertise and resources, and increase our understanding of each member's role in the complex process of developing new medicines. International Neonatal Consortium is the voice for neonates, who do not cast votes or speak for themselves. National Association of Neonatal Nurses is proud to actively engage in this global initiative.
Contributed by Wakako M. Eklund, DNP, APN, NNP-BC.
1. Brumfield M. The Critical Path Institute: transforming competitors into collaborators. Nature Rev Drug Discov. 2014;13:785-786. [Context Link]
2. Offringa M, Davis JM, Turner MA, et al. Applying regulatory science to develop safe and effective medicines for neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28-29, 2014. Ther Innov Regul Sci. 2015;49:623-631. [Context Link]
3. Warrier I, Du W, Natarajan G, Salari V, Aranda J. Patterns of drug utilization in a neonatal intensive care unit. J Clin Pharmacol. 2006;46:449-455. [Context Link]
4. Conroy S, McIntyre J. The use of unlicensed and off-label medicines in the neonate. Semin Fetal Neonatal Med. 2005;10:115-122. [Context Link]
5. Kumar P, Walker JK, Hurt KM, Bennett KM, Grosshans N, Fotis MA. Medication use in the neonatal intensive care unit: current patterns and off-label use of parenteral medications. J Pediatr. 2008;152:412-415. [Context Link]
6. Davis JM, Connor EM, Wood AJ. The need for rigorous evidence on medication use in preterm infants: is it time for a neonatal rule? JAMA. 2012;308:1435-1436. [Context Link]
7. Library of Congress. S.2041-Promoting Life-Saving New Therapies for Neonates Act of 2015. https://www.congress.gov/bill/114th-congress/senate-bill/2041/text. Published 2015. Accessed December 1, 2015. [Context Link]
8. McCune SK, Mulugeta YA. Regulatory science needs for neonates: a call for neonatal community collaboration and innovation. Front Pediatr. 2014;2:135. [Context Link]
9. Laughon MM, Avant D, Tripathi N, et al. Drug labeling and exposure in neonates. JAMA Pediatr. 2014;168:130-136. [Context Link]
DEADLY CRIB BUMPERS
In spite of being listed as one of the most dangerous baby products,1 and guidance from the American Academy of Pediatrics to avoid their use, crib bumper pads remain popular with parents. Except where banned, parents purchase crib bumpers purportedly to protect their infants from the trauma of bumping against the crib rails or having an arm or leg stuck in the gap. Parents no doubt believe that the store would not sell them if they were not safe. And let's face it, they are cute.
Crib bumpers are known to be associated with accidental death in infants, but few systematic data on crib bumper deaths have been conducted. The question of causal mechanisms, and whether any other factors, such as clutter (comforters, blankets, pillows, toys) in the crib, increase risk for bumper-related deaths was recently examined in a study by Scheers and colleagues.1
Bumper-related deaths and injuries were identified from the US Consumer Product Safety Commission databases and according to the mechanism of death or injury. Deaths and injuries from bumper pads have increased over previous years.
From 1985 to 2012, Consumer Product Safety Commission received reports of 48 bumper-related suffocations, 67% of which were associated with a bumper alone (no additional crib clutter) and 33% with a bumper and another object. When added to deaths reported to the National Center for the Review and Prevention of Child Deaths from 2008 to 2011, the total number of reported bumper-related deaths is 77. The mechanisms of bumper-related deaths vary but include the infant being smothered between the bumper and a part of the crib and choking on bumper ties. Older infants have used the bumper as a stepping stone to climb out of the crib and fall, striking their heads on the floor.
It is clear that neither public health messages nor voluntary industry modifications of crib bumper pads to date have been sufficient to curb preventable deaths associated with bumpers. Parents and caregivers of newborn infants must be strongly cautioned against using crib bumper pads. Explaining that bumper pads do not, in fact, prevent injury to the infant, making their use entirely superfluous, might encourage parents to heed this warning.
1. Scheers NJ, Woodard DW, Thach BT. Crib bumpers continue to cause infant deaths: a need for a new preventive approach [published online ahead of print November 24, 2015]. J Pediatr. [Context Link]
PSYCHOSOCIAL SUPPORT IN THE NEONATAL INTENSIVE CARE UNIT, FROM A TO Z
A special supplemental issue of the Journal of Perinatology is devoted to articles that aim to help neonatal intensive care units (NICUs) improve psychosocial support of everyone within their walls: parents, babies, and staff.1 Beginning with the standards of psychosocial support in the NICU, the 6 articles that follow cover the topics of involving family in developmental care,2 peer-to-peer support for parents,3 the role of mental health professionals in the NICU,4 palliative and bereavement care,5 discharge planning,6 and staff education to enhance psychosocial support for parents.7 The articles emphasize the concept that providing comprehensive psychosocial support requires interdisciplinary collaboration, and the importance of continuity of care, beginning in the antepartum period and extending to follow-up after discharge from the NICU. Each article was written by a multidisciplinary team and includes recommendations to help NICUs develop or improve psychosocial support, developmental care, and other family-centered programs in the NICU. This issue is a tremendous resource for NICU caregivers, and, at the time of this writing, is available online, with full-text access.
1. Hynan MT, Hall SL. Psychosocial program standards for the NICU. J Perinatol. 2015;35(suppl 1):S1-S4. [Context Link]
2. Craig JW, Glick C, Phillips R, Hall SL, Smith J, Browne J. Recommendations for involving the family in the developmental care of the NICU baby. J Perinatol. 2015;35(suppl 1):S5-S8. [Context Link]
3. Hall SL, Ryan DJ, Beatty J, Grubbs L. Recommendations for peer-to-peer support for NICU parents. J Perinatol. 2015;35(suppl 1):S9-S13. [Context Link]
4. Hynan MT, Steinberg Z, Baker L, et al. Recommendations for mental health professionals in the NICU. J Perinatol. 2015;35:S14-S18. [Context Link]
5. Kenner C, Press J, Ryan D. Recommendations for palliative and bereavement care in the NICU: a family-centered integrative approach. J Perinatol. 2015;35:(suppl 1):S19-S23. [Context Link]
6. Purdy IB, Craig JW, Zeanah P. NICU discharge planning and beyond: recommendations for parent psychosocial support. J Perinatol. 2015;35(suppl 1):S24-S28. [Context Link]
7. Hall SL, Cross J, Selix NW, et al. Recommendations for enhancing psychosocial support of NICU parents through staff education and support. J Perinatol. 2015;35(suppl 1):S29-S36. [Context Link]