Contemporary use of prophylactic probiotics in NICUs in the United States: a survey update.

OBJECTIVE: In 2015, 14.0% of US NICUs administered probiotics to very low birth weight infants. Current probiotic use prior to and after the Fall of 2023 (when FDA warnings were issued) remains unknown. STUDY DESIGN: A survey was distributed to the American Academy of Pediatrics Section on Neonatal and Perinatal Medicine (August-November/2022) and Neonatology Solutions' Level III/IV NICUs (January-April/2023). Probiotic administration practices were investigated. RESULTS: In total, 289 unique NICUs and 406 providers responded to the survey. Of those, 29.1% of NICUs administered prophylactic probiotics to premature neonates, however, this decreased considerably after FDA warnings were issued. Additionally, 71.4% of providers stated willingness to administer probiotics to premature infants if there was an FDA-approved formulation. CONCLUSIONS: Probiotic use in US NICUs increased between 2015 and the Fall of 2023 and then dropped dramatically following warning letters from the FDA. The introduction of an FDA-approved probiotic may further expand administration.

Trends and Racial and Geographic Differences in Infant Mortality in the United States Due to Necrotizing Enterocolitis, 1999 to 2020.

This cohort study analyzes yearly trends in necrotizing enterocolitis­related infant mortality rates (NEC-IMR) from 1999 to 2020, overall and by Black and White race, and described Black-to-White NEC-IMR ratios and NEC-IMR for US states.

Long-term outcomes and life-impacts of necrotizing enterocolitis: A survey of survivors and parents.

Necrotizing enterocolitis (NEC) is a devastating intestinal disease that primarily affects premature infants. Necrotizing enterocolitis is associated with adverse two-year outcomes, yet limited research has evaluated the impact of NEC on long-term complications and quality of life in children older than two years. We conducted a survey to characterize the long-term impact of NEC on physical and mental health, social experiences, and quality of life as self-reported by adult NEC survivors and parents of children who survived NEC. To our knowledge, this is the first study that describes the lived experience of NEC survivors and parents of children affected by NEC to understand their experience years after the original diagnosis. Our survey results describe that NEC survivors and parents of children affected by NEC experience long-term complications that impact their physical and mental health, social experiences, and quality of life.

Challenges in diagnosing necrotizing enterocolitis.

One of the many challenges with necrotizing enterocolitis (NEC) remains our inability to make an accurate diagnosis of NEC. The lack of a unifying cause and multiple variations in presentations lead to great uncertainty with NEC. Separating out the needs of the researcher wanting to define NEC from the clinician and patient family's perspectives who want an accurate diagnosis for NEC is important. The need to augment and/or replace the outdated modified Bell staging criteria is crucial to improving NEC management. Emerging literature suggests that genetic susceptibility and stool microbiota signatures may help identify preterm infants at increased risk of the disease. Ongoing studies using single or multi-omic approaches may help to characterize biomarkers that will aid in the prediction or early diagnosis of NEC, as well as differentiate other causes of severe bowel injury. Bowel ultrasound shows promise in improving our diagnostic accuracy for NEC but has been slow in adoption. Patient family perspectives are key in accelerating our efforts to integrate newer diagnostic methods into practice.

Strategies to increase the use of mother's own milk for infants at risk of necrotizing enterocolitis.

High-dose mother's own milk (MOM) feedings during the first 14 days post birth reduce the risk of necrotizing enterocolitis in very low birthweight (VLBW; <1500 g birthweight). However, high-dose MOM feedings are only possible if mothers provide sufficient quantities of MOM in a timely manner, and data indicate that the lack of MOM during the early post-birth period is a global problem. This paper reviews the modifiable and unmodifiable barriers to accessing adequate quantities of MOM during the early post-birth period and proposes evidence-based strategies to increase and improve the use of MOM during the neonatal intensive care unit (NICU) hospitalization with an emphasis on the critical first 2 weeks post birth.

New directions in necrotizing enterocolitis with early-stage investigators.

The 2019 Necrotizing Enterocolitis (NEC) Symposium expanded upon the NEC Society's goals of bringing stakeholders together to discuss cutting-edge science, potential therapeutics and preventative measures, as well as the patient-family perspectives of NEC. The Symposium facilitated discussions and shared knowledge with the overarching goal of creating "A World Without NEC." To accomplish this goal, new research to advance the state of the science is necessary. Over the last decade, several established investigators have significantly improved our understanding of the pathophysiology of NEC and they have paved the way for the next generation of clinician-scientists funded to perform NEC research. This article will serve to highlight the contributions of these young clinician-scientists that seek to elucidate how immune, microbial and nervous system dysregulation contributes to the pathophysiology of NEC.

Opportunities for the federal government to advance necrotizing enterocolitis research.

BACKGROUND: Necrotizing enterocolitis (NEC) is a leading cause of morbidity and mortality in the neonatal ICU with minimal progress in the research. METHODS: Federal webpages were queried to look for funding opportunity announcements (FOAs) and to develop lists of funded projects on NEC to identify gaps in NEC-related research topics. RESULTS: Over the past 30 years, the National Institutes of Health (NIH) issued two FOAs to stimulate research on NEC with $4.1 million set aside for the first year of respective funding. We identified 23 recently funded studies of which 18 were research projects, 4 training grants, and 1 conference grant support. Only one grant focused on parent and family engagement in the NICU. CONCLUSION: There are significant research gaps that can be addressed with adequate funding from the federal government on the prevention and treatment of NEC.

Parent and Provider Perspectives on the Imprecise Label of "Human Milk Fortifier" in the NICU.

In the critical care of preterm infants, feeding is complex and potentially harmful to an immature gastrointestinal system. Parents have expressed the desire to be fully informed about what is being fed to their child, as this places them in the best position to nurture their child's health. In the parent-engaged setting of the Necrotizing Enterocolitis Symposium, NICU parents expressed concern and confusion about how cow's milk product and donor human milk product both carry the label "Human Milk Fortifier" (HMF). Accordingly, two online surveys were developed to characterize how the label HMF is used and interpreted in the NICU by parents and providers. Of 774 United States participants, only 21.9% of providers reported consistently describing the source of HMF to parents, and only 20.6% of parents whose child received an HMF product report knowing the source. Parents expressed that they were "not given information" regarding HMF, while both parents and healthcare providers expressed that "the label (HMF) is misleading". This study documents the ambiguity around the label HMF as well as the need for more specific language and clearer communication.

Development of the NEC-Zero Toolkit: Supporting Reliable Implementation of Necrotizing Enterocolitis Prevention and Recognition.

The goal of the NEC-Zero project is to reduce the burden of necrotizing enterocolitis (NEC) by increasing access to evidence-based tools to help clinicians and parents integrate evidence into daily care. It involves (a) human milk feeding with prioritized mother's own milk; (b) use of a unit-adopted standardized feeding protocol; (c) a unit-adopted strategy for timely recognition that integrates risk awareness and a structured communication tool when symptoms develop; and (d) stewardship of empiric antibiotics and avoidance of antacids. A toolkit for caregivers and parents was developed to make implementation consistent. For clinicians the toolkit includes: the GutCheckNEC risk score, a structured communication tool, the "Avoiding NEC" checklist, and the NEC-Zero website. For parents, NEC-Zero tools include the website, three educational brochures in English and Spanish, and a collaborative care video produced with the NEC Society. This article describes the toolkit and how it has been accessed and used.

Biobanking for necrotizing enterocolitis: Needs and standards.

BACKGROUND: Necrotizing enterocolitis (NEC) is a devastating gastrointestinal disease that primarily affects premature infants. Despite medical advances, mortality and morbidity from NEC are still unacceptably high. This is partly because of the lack of specific biomarkers and therapies for this disease. Availability of high-quality biological samples and the associated data from premature infants are key to advance our understanding of NEC, and for biomarker discovery and drug development. To that end, the NEC Society Biorepository was established with the goal of promoting studies in human infants through sharing specialized biospecimen and data procurement for NEC research. OBJECTIVE: In this review, we will discuss the required infrastructure for biobanks, discuss the importance of informatics management, and emphasize the logistical requirements for sharing specimens. Finally, we will discuss the mechanism for how tissues and material will be shared between the institutions. CONCLUSION: We have developed a state-of-the-art biobank for human infants to advance the field of NEC research. With the NEC Society Biorepository, we seek to facilitate and accelerate the basic and translational studies on NEC to provide hope to the infants afflicted with NEC and their families. STUDY TYPE: Review article, level V.

Expert consensus to weight an adherence score for audit and feedback of practices that prevent necrotizing enterocolitis in very low birth weight infants.

OBJECTIVE: Necrotizing enterocolitis (NEC) is a catastrophic abdominal complication threatening the life of premature infants, but adoption of prevention and early recognition practices differs as do NEC rates in Neonatal Intensive Care Units (NICUs). The purpose of this research was to validate and weight an evidence-based adherence score (aka NEC-Zero Adherence Score) to prevent and foster timely recognition of NEC. STUDY DESIGN: An electronic Delphi (e-Delphi) approach was used to identify consensus. NEC experts were recruited via the NEC Society and surveyed until consensus and stability criteria for the Delphi were met (≥70% consensus and mean responses changed <15% between rounds). RESULTS: Expert panelists (n=22) were experienced (M=17.6, SD 11years) and predominately physicians (68%) or neonatal nurse practitioners (18%). Consensus (>70% by item) supported a 10 point score. Points were distributed across 1) an exclusive human milk diet (5 points), 2) standardized feeding protocols (3 points), 3) antibiotic stewardship (1 point), and 4) a unit-specified approach to early recognition (1 point). Withholding feeding during transfusion was controversial (M=0.50, SD 0.73) and met consensus criteria to drop from the score. CONCLUSIONS: Holding feeding during transfusion was dropped from the score. Relationships between the score and unit NEC rates as well as its utility for use in audit and feedback should be studied in the future.

Enhancing NICU parent engagement and empowerment.

Within the neonatal intensive care unit (NICU), parent engagement and empowerment are of critical importance, particularly when infants are at risk of developing severe complications, such as necrotizing enterocolitis (NEC). Stakeholders within the NICU, including the fragile patients, families, clinicians, staff, and administration, benefit when parents are a valued member of their baby's care team. The 2017 NEC Symposium explored the experiences of families whose infants were impacted by NEC, the barriers to effective partnership, and promising solutions. Parents want to participate in their baby's care, and crave honest, timely, comprehensive information regarding their baby's health and potential outcomes. Clinicians and staff should implement a specific set of Family-Centered Care policies and practices within the NICU to foster a culture of collaboration with parents of premature and fragile infants.

Roles and Experiences of Parents in Necrotizing Enterocolitis: An International Survey of Parental Perspectives of Communication in the NICU.

BACKGROUND: Although partnering with parents is important to improving neonatal outcomes, no studies have investigated what parents are taught, remember, or experience when their child is afflicted with necrotizing enterocolitis (NEC). PURPOSE: To characterize parental perceptions of communication and support they were given about NEC. METHODS: An online survey was developed, reviewed for face validity, and then administered to parents whose child had experienced NEC. Quantitative data were analyzed using descriptive statistics, and qualitative data were analyzed using a qualitative descriptive approach. FINDINGS: Parents (N = 110) wanted to know the risk factors and warning signs for NEC and wanted to be told as soon as their child was admitted to the neonatal intensive care unit (NICU). Information provided before diagnosis was felt to be poor by the majority of families, with only 32% feeling satisfied or very satisfied. No parent wrote that they were "scared" by information provided to them about NEC; in fact, parents were dissatisfied when they received "sugar-coated" information. Engaged parents were significantly more satisfied than those who were not informed, had their concerns and suggestions dismissed, or who had to advocate for their baby against clinician opposition (eg, activating the chain of command). IMPLICATIONS FOR PRACTICE: Areas for quality improvement include better communication and collaboration with parents through early engagement in NEC prevention using modalities beyond verbal instruction. IMPLICATIONS FOR RESEARCH: More research is needed on how best to engage parents, especially to engage in prevention, and how doing so affects satisfaction and outcomes.