James I. Hagadorn

Inhaled Nitric Oxide Use in Neonates With Congenital Diaphragmatic Hernia

OBJECTIVE: To describe the use of inhaled nitric oxide (INO) in newborns with congenital diaphragmatic hernia (CDH). METHODS: Pediatric Health Information System data were queried for newborns with CDH admitted at <8 days of age at tertiary care US pediatric hospitals between 2003 and 2011. INO treatment status and timing in relation to CDH repair were determined for each infant. Hospital-specific rates of INO use, extracorporeal membrane oxygenation (ECMO) use, and mortality were determined. RESULTS: Data were analyzed for 1713 neonates with CDH admitted to 33 hospitals. More than half (57%) received INO during their inpatient stay, and utilization varied dramatically between hospitals (34% to 92%). Neonates treated with INO accumulated >

Trends and variation in management and outcomes of very low-birth-weight infants with patent ductus arteriosus

81 million in pharmacy charges. The proportion of infants receiving INO as well as their duration of therapy increased significantly during the study period. The rate of ECMO utilization and mortality did not change significantly during the study period. Hospital-specific mortality rates did not correlate with INO therapy, ECMO utilization, or case volume. CONCLUSIONS: INO use in neonates with CDH is widespread, and has increased at many US tertiary pediatric hospitals without contemporaneous change in ECMO utilization or mortality. The improvement of evidence-based guidelines for the use of INO in newborns with CDH could lead to a reduction in health care costs for these patients.

Systematic Review of the Human Milk Microbiota

Background:We examined recent trends and interhospital variation in use of indomethacin, ibuprofen, and surgical ligation for patent ductus arteriosus (PDA) in very-low-birth-weight (VLBW) infants.Methods:Included in this retrospective study of the Pediatric Hospital Information System database were 13,853 VLBW infants from 19 US children’s hospitals, admitted at age < 3 d between 1 January 2005 and 31 December 2014. PDA management and in-hospital outcomes were examined for trends and variation.Results:PDA was diagnosed in 5,719 (42%) VLBW infants. Cyclooxygenase inhibitors and/or ligation were used in 74% of infants with PDA overall, however studied hospitals varied greatly in PDA management. Odds of any cyclooxygenase inhibitor or surgical treatment for PDA decreased 11% per year during the study period. This was temporally associated with improved survival but also with increasing bronchopulmonary dysplasia, periventricular leukomalacia, retinopathy of prematurity, and acute renal failure in unadjusted analyses. There was no detectable correlation between hospital-specific changes in PDA management and hospital-specific changes in outcomes of preterm birth during the study period.Conclusion:Use of cyclooxygenase inhibitors and ligation for PDA in VLBW infants decreased over a 10-y period at the studied hospitals. Further evidence is needed to assess the impact of this change in PDA management.

The Effect of a Donor Milk Policy on the Diet of Very Low Birth Weight Infants.

Human milk–associated microbes are among the first to colonize the infant gut and may help to shape both short- and long-term infant health outcomes. We performed a systematic review to characterize the microbiota of human milk. Relevant primary studies were identified through a comprehensive search of PubMed (January 1, 1964, to June 31, 2015). Included studies were conducted among healthy mothers, were written in English, identified bacteria in human milk, used culture-independent methods, and reported primary results at the genus level. Twelve studies satisfied inclusion criteria. All varied in geographic location and human milk collection/storage/analytic methods. Streptococcus was identified in human milk samples in 11 studies (91.6%) and Staphylococcus in 10 (83.3%); both were predominant genera in 6 (50%). Eight of the 12 studies used conventional ribosomal RNA (rRNA) polymerase chain reaction (PCR), of which 7 (87.5%) identified Streptococcus and 6 (80%) identified Staphylococcus as present. Of these 8 studies, 2 (25%) identified Streptococcus and Staphylococcus as predominant genera. Four of the 12 studies used next-generation sequencing (NGS), all of which identified Streptococcus and Staphylococcus as present and predominant genera. Relative to conventional rRNA PCR, NGS is a more sensitive method to identify/quantify bacterial genera in human milk, suggesting the predominance of Streptococcus and Staphylococcus may be underestimated in studies using older methods. These genera, Streptococcus and Staphylococcus, may be universally predominant in human milk, regardless of differences in geographic location or analytic methods. Primary studies designed to evaluate the effect of these 2 genera on short- and long-term infant outcomes are warranted.

Donor Human Milk Bank Data Collection in North America An Assessment of Current Status and Future Needs

Background: Use of donor milk (DM) to supplement mother’s own milk (MOM) in the neonatal intensive care unit (NICU) is steadily increasing based on health and developmental benefits to premature infants. A paucity of data exists documenting the effect of DM use on the diet of very low birth weight (VLBW) infants related to the implementation of a DM policy. Objective: This study aimed to compare VLBW enteral intake type in the first 28 days of life before versus after establishing a DM policy. Methods: This single-center pre–post prospective cohort study included all inborn infants ≤ 1500 grams in a level 4 NICU remaining hospitalized at 28 days and admitted either before (pre-DM period, October 2009–March 2010) or after (DM period, October 2010–September 2012) implementing a DM policy. The feeding protocol was unchanged in both periods. Collected data included maternal/infant demographics, infant clinical data, and daily volume of enteral intake as MOM, DM, and formula. The proportion of enteral feeds from these sources during the first 28 days of life was compared pre-DM versus DM. Results: Compared to pre-DM baseline, formula exposure was significantly decreased, and human milk exposure and proportion of diet as human milk increased. The proportion of infants fed exclusively human milk increased. Exposure to and proportion of diet as MOM was unchanged. Infants were fed earlier in the DM period. Conclusion: Establishment of a DM policy was associated with reduced exposure to formula, promoting an exclusively human milk diet, with earlier initiation of feeds and no decrease in use of MOM.

Alarm Safety and Alarm Fatigue

Background: The Human Milk Banking Association of North America (HMBANA) is a nonprofit association that standardizes and facilitates the establishment and operation of donor human milk (DHM) banks in North America. Each HMBANA milk bank in the network collects data on the DHM it receives and distributes, but a centralized data repository does not yet exist. In 2010, the Food and Drug Administration recognized the need to collect and disseminate systematic, standardized DHM bank data and suggested that HMBANA develop a DHM data repository. Objectives: This study aimed to describe data currently collected by HMBANA DHM banks and evaluate feasibility and interest in participating in a centralized data repository. Methods: We conducted phone interviews with individuals in different HMBANA milk banks and summarized descriptive statistics. Results: Eight of 13 (61.5%) sites consented to participate. All respondents collected donor demographics, and half (50%; n = 4) rescreened donors after 6 months of continued donation. The definition of preterm milk varied between DHM banks (≤ 32 to ≤ 40 weeks). The specific computer program used to house the data also differed. Half (50%; n = 4) indicated that they would consider participation in a centralized repository. Conclusions: Without standardized data across all HMBANA sites, the creation of a centralized data repository is not yet feasible. Lack of standardization and transparency may deter implementation of donor milk programs in the neonatal intensive care unit setting and hinder benchmarking, research, and quality improvement initiatives.

Variability of Criteria for Pasteurized Donor Human Milk Use A Survey of U.S. Neonatal Intensive Care Unit Medical Directors

Clinical alarm systems have received significant attention in recent years following warnings from hospital accrediting and health care technology organizations regarding patient harm caused by unsafe practices. Alarm desensitization or fatigue from frequent, false, or unnecessary alarms, has led to serious events and even patient deaths. Other concerns include settings inappropriate to patient population or condition, inadequate staff training, and improper use or disabling. Research on human factors in alarm response and of functionality of medical devices will help clinicians develop appropriate policies, practices, and device settings for clinical alarms in neonatal intensive care units.

Optimal Periods of Exclusive Breastfeeding Associated with Any Breastfeeding Duration through One Year

BACKGROUND Use of donor human milk (DHM) is increasing, but criteria for its use are not well defined. MATERIALS AND METHODS We conducted a 34-question Internet-based survey of medical directors of U.S. level 3 and level 4 neonatal intensive care units (NICUs), with the goal of describing specifics of policies developed to guide DHM use in U.S. NICUs. Respondents reported NICU characteristics and details of policies concerning DHM use. Policy-specified criteria for DHM use, if any, were described. Bivariate and multivariate analyses were used to identify NICU characteristics associated with DHM use. RESULTS Respondents returned 153 (33%) surveys, with use of DHM reported by 91 (59%). Donor human milk use was more likely with more than 100 annual admissions <1500 g at birth (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.1-4.7) and with Vermont-Oxford Network participants (OR, 4.6; 95% CI, 1.8-11.6). Among 72 NICUs reporting a written policy, criteria for providing DHM required birth weights varying from <1000 to <1800 g and/or gestational ages from <28 to <34 completed weeks, but criteria were reportedly waived in many circumstances. Policies regarding duration of DHM therapy were similarly varied. CONCLUSIONS Criteria for initiating and continuing DHM vary widely among U.S. level 3 and level 4 NICUs. Donor human milk use is more frequent in NICUs with many very low-birth-weight admissions and among Vermont-Oxford Network participants. Further research is needed to define short- and long-term outcomes and cost benefits of DHM use in subgroups of NICU patients, particularly for uses other than necrotizing enterocolitis prevention.

Variability of Criteria for Pasteurized Donor Human Milk Use: A Survey of U.S. Neonatal ICU Medical Directors

OBJECTIVE To quantify optimal minimum durations of exclusive breastfeeding associated with maintenance of any breastfeeding at 15 time points during the first year of life. STUDY DESIGN Mothers (n = 1189) from the prospective Infant Feeding Practices Study II cohort who initiated exclusive breastfeeding with healthy term infants were included. In a 80:20 split-sample validation study, receiver operating characteristic curves estimated optimal minimum durations of exclusive breastfeeding needed to predict maintenance of any breastfeeding at 15 time points during the first year (n = 951). Logistic regression estimated the predictive performance of the identified thresholds adjusted for maternal age, race, education, parity, support system, and return-to-work status. Results were validated in the remaining 20% (n = 238). RESULTS Optimal minimum durations ranged from 4.0-17.1 weeks of exclusive breastfeeding associated with maintenance of any breastfeeding at 15 time points. All estimated threshold durations were statistically significant after adjustment. CONCLUSIONS Using a methodological approach unique to breastfeeding duration research, the authors report optimal durations of exclusive breastfeeding associated with duration of any breastfeeding at time points throughout the first year. Perinatal clinicians, pediatricians, lactation professionals, policymakers, researchers, and families might apply these findings to achieve desirable collective breastfeeding duration outcomes.

Variability in Duration of Outpatient Diuretic Therapy in Bronchopulmonary Dysplasia: A Clinical Experience

BACKGROUND Use of donor human milk (DHM) is increasing, but criteria for its use are not well defined. MATERIALS AND METHODS We conducted a 34-question Internet-based survey of medical directors of U.S. level 3 and level 4 neonatal intensive care units (NICUs), with the goal of describing specifics of policies developed to guide DHM use in U.S. NICUs. Respondents reported NICU characteristics and details of policies concerning DHM use. Policy-specified criteria for DHM use, if any, were described. Bivariate and multivariate analyses were used to identify NICU characteristics associated with DHM use. RESULTS Respondents returned 153 (33%) surveys, with use of DHM reported by 91 (59%). Donor human milk use was more likely with more than 100 annual admissions <1500 g at birth (odds ratio [OR], 2.2; 95% confidence interval [CI], 1.1-4.7) and with Vermont-Oxford Network participants (OR, 4.6; 95% CI, 1.8-11.6). Among 72 NICUs reporting a written policy, criteria for providing DHM required birth weights varying from <1000 to <1800 g and/or gestational ages from <28 to <34 completed weeks, but criteria were reportedly waived in many circumstances. Policies regarding duration of DHM therapy were similarly varied. CONCLUSIONS Criteria for initiating and continuing DHM vary widely among U.S. level 3 and level 4 NICUs. Donor human milk use is more frequent in NICUs with many very low-birth-weight admissions and among Vermont-Oxford Network participants. Further research is needed to define short- and long-term outcomes and cost benefits of DHM use in subgroups of NICU patients, particularly for uses other than necrotizing enterocolitis prevention.