Randomized trial of azithromycin to eradicate Ureaplasma respiratory colonization in preterm infants: 2-year outcomes.

BACKGROUND: To assess the potential impact of azithromycin treatment in the first week following birth on 2-year outcomes in preterm infants with and without Ureaplasma respiratory colonization who participated in a double-blind, placebo-controlled randomized controlled trial. METHODS: Respiratory morbidity was assessed at NICU discharge and at 6, 12, and 22-26 months corrected age using pulmonary questionnaires. Comprehensive neurodevelopmental assessments were completed between 22 and 26 months corrected age. The primary and secondary composite outcomes were death or severe respiratory morbidity and death or moderate-severe neurodevelopmental impairment, respectively, at 22-26 months corrected age. RESULTS: One hundred and twenty-one randomized participants (azithromycin, N = 60; placebo, N = 61) were included in the intent-to-treat analysis. There were no significant differences in death or serious respiratory morbidity (34.8 vs 30.4%, p = 0.67) or death or moderate-severe neurodevelopmental impairment (47 vs 33%, p = 0.11) between the azithromycin and placebo groups. Among all trial participants, tracheal aspirate Ureaplasma-positive infants experienced a higher frequency of death or serious respiratory morbidity at 22-26 months corrected age (58%) than tracheal aspirate Ureaplasma-negative infants (34%) or non-intubated infants (21%) (p = 0.028). CONCLUSIONS: We did not observe strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes in preterm infants treated with azithromycin in the first week of life compared to placebo. IMPACT: No strong evidence of a difference in long-term pulmonary and neurodevelopment outcomes was identified at 22-26 months corrected age in infants treated with azithromycin in the first week of life compared to placebo. The RCT is the first study of 2-year pulmonary and neurodevelopmental outcomes of azithromycin treatment in ELGANs. Provides evidence that ELGANs with lower respiratory tract Ureaplasma have the most frequent serious respiratory morbidity in the first 2 years of life, suggesting that a Phase III trial of azithromycin to prevent BPD targeting this population is warranted.

Breastfeeding and Formula Selection in Neonatal Abstinence Syndrome.

OBJECTIVE: This study aimed to determine if formula selection, low lactose versus standard term formula, has an effect on outcomes with a comparison to breastfed infants. STUDY DESIGN: Retrospective cohort study of neonates ≥35 weeks gestation born with Neonatal Abstinence Syndrome (NAS) was conducted from July 2014 to November 2016. Primary outcomes included length of pharmacologic treatment (LOT), and length of stay (LOS), and weight change per day comparing term standard and low lactose formula majority feeding infants with secondary outcomes comparing breast fed majority feeding infants. RESULTS: After investigating feeding methods for 249 NAS infants, a direct comparison of formula groups showed no differences in LOS (3, 95% confidence interval [CI]: -1.1 to 7 days), LOT (3.9, 95% CI: -0.4 to 8.1 days), or weight change per day (-2.4, 95% CI: -11.7 to 6.9 g/day). Breastfeeding improved LOT by 6.9 (95% CI: 3.4-10.5) and 10.8 days (95% CI: 5.9-15.6) and LOS by 7.4 (95% CI: 4.1-10.7) and 10.3 (95% CI: 5.8-14.9) days all reaching significance, in comparison to term and low lactose formula groups, respectively. Weight change per day was greater in the breast versus formula feeding groups when compared individually. CONCLUSION: We detected no benefit to low lactose formula in NAS infants. Breastfeeding is associated with clinical reduction in LOS and LOT but is associated with increased weight loss. KEY POINTS: · Best formula choice for a neonatal abstinence syndrome (NAS) infant is unknown.. · Many NAS moms cannot breastfeed.. · Low lactose formula has no impact on NAS outcomes..

Outbreak of Mycobacterium chelonae infection associated with tattoo ink.

BACKGROUND: In January 2012, on the basis of an initial report from a dermatologist, we began to investigate an outbreak of tattoo-associated Mycobacterium chelonae skin and soft-tissue infections in Rochester, New York. The main goals were to identify the extent, cause, and form of transmission of the outbreak and to prevent further cases of infection. METHODS: We analyzed data from structured interviews with the patients, histopathological testing of skin-biopsy specimens, acid-fast bacilli smears, and microbial cultures and antimicrobial susceptibility testing. We also performed DNA sequencing, pulsed-field gel electrophoresis (PFGE), cultures of the ink and ingredients used in the preparation and packaging of the ink, assessment of source water and faucets at tattoo parlors, and investigation of the ink manufacturer. RESULTS: Between October and December 2011, a persistent, raised, erythematous rash in the tattoo area developed in 19 persons (13 men and 6 women) within 3 weeks after they received a tattoo from a single artist who used premixed gray ink; the highest occurrence of tattooing and rash onset was in November (accounting for 15 and 12 patients, respectively). The average age of the patients was 35 years (range, 18 to 48). Skin-biopsy specimens, obtained from 17 patients, showed abnormalities in all 17, with M. chelonae isolated from 14 and confirmed by means of DNA sequencing. PFGE analysis showed indistinguishable patterns in 11 clinical isolates and one of three unopened bottles of premixed ink. Eighteen of the 19 patients were treated with appropriate antibiotics, and their condition improved. CONCLUSIONS: The premixed ink was the common source of infection in this outbreak. These findings led to a recall by the manufacturer.

Prolonged early antibiotic use and bronchopulmonary dysplasia in very low birth weight infants.

OBJECTIVE: The objective of the article is to determine if > 48 hours of antibiotic treatment during the 1st week of life is associated with subsequent isolation of bacteria from the endotracheal tube (ETT), and an increased risk of bronchopulmonary dysplasia (BPD). STUDY DESIGN: Retrospective cohort study of very low birth weight infants. Routine weekly surveillance ETT cultures were obtained to monitor bacterial colonization in all intubated infants. Risk factors for BPD were assessed using unadjusted and multivariable analyses. RESULTS: In the study sample (n = 906), infants with BPD (n = 182) were more likely to have received > 48 hours antibiotic treatment (31 vs. 14%, p < 0.01) and have a resistant gram-negative bacilli in ETT (7 vs. 2%, p = 0.0001) compared with infants without BPD. Treatment with > 48 hours of antibiotics remained associated with BPD (adjusted odds ratio, 2.2; 95% confidence interval, 1.4-3.5) after controlling for confounding variables. CONCLUSIONS: Antibiotic duration > 48 hours in the 1st week of life was associated with subsequent BPD and the presence of resistant bacteria in routine ETT cultures.

Randomised trial of azithromycin to eradicate Ureaplasma in preterm infants.

OBJECTIVE: To test whether azithromycin eradicates Ureaplasma from the respiratory tract in preterm infants. DESIGN: Prospective, phase IIb randomised, double-blind, placebo-controlled trial. SETTING: Seven level III-IV US, academic, neonatal intensive care units (NICUs). PATIENTS: Infants 240-286 weeks' gestation (stratified 240-266; 270-286 weeks) randomly assigned within 4 days following birth from July 2013 to August 2016. INTERVENTIONS: Intravenous azithromycin 20 mg/kg or an equal volume of D5W (placebo) every 24 hours for 3 days. MAIN OUTCOME MEASURES: The primary efficacy outcome was Ureaplasma-free survival. Secondary outcomes were all-cause mortality, Ureaplasma clearance, physiological bronchopulmonary dysplasia (BPD) at 36 weeks' postmenstrual age, comorbidities of prematurity and duration of respiratory support. RESULTS: One hundred and twenty-one randomised participants (azithromycin: n=60; placebo: n=61) were included in the intent-to-treat analysis (mean gestational age 26.2±1.4 weeks). Forty-four of 121 participants (36%) were Ureaplasma positive (azithromycin: n=19; placebo: n=25). Ureaplasma-free survival was 55/60 (92% (95% CI 82% to 97%)) for azithromycin compared with 37/61 (61% (95% CI 48% to 73%)) for placebo. Mortality was similar comparing the two treatment groups (5/60 (8%) vs 6/61 (10%)). Azithromycin effectively eradicated Ureaplasma in all azithromycin-assigned colonised infants, but 21/25 (84%) Ureaplasma-colonised participants receiving placebo were culture positive at one or more follow-up timepoints. Most of the neonatal mortality and morbidity was concentrated in 21 infants with lower respiratory tract Ureaplasma colonisation. In a subgroup analysis, physiological BPD-free survival was 5/10 (50%) (95% CI 19% to 81%) among azithromycin-assigned infants with lower respiratory tract Ureaplasma colonisation versus 2/11 (18%) (95% CI 2% to 52%) in placebo-treated infants. CONCLUSION: A 3-day azithromycin regimen effectively eradicated respiratory tract Ureaplasma colonisation in this study. TRIAL REGISTRATION NUMBER: NCT01778634.

Outcome Differences in Neonates Exposed In-Utero to Opioids Managed in the NICU Versus Pediatric Floor.

OBJECTIVE: The aim of the study is to determine length of stay and length of treatment in infants with neonatal abstinence syndrome (NAS) in the neonatal intensive care unit (NICU) compared to those in the pediatric floor. METHODS: Retrospective cohort of infants ≥34 weeks gestation admitted with diagnosis of NAS at a single regional perinatal referral center from July 2014 to October 2015. A standardized NAS protocol for both the NICU and pediatric floor, which included guidelines for the initiation of oral morphine, escalation, and weaning, was followed. Initial location of treatment, NICU or pediatric floor, was determined by physiological stability following birth. Statistical analysis included 1-way analysis of variance and chi-square. Multivariable analysis was performed using generalized linear models to account for confounding. RESULTS: The study included 235 infants, 80 (34%) were cared for in the NICU. Infants in the NICU had a longer length of stay (27.1 ±â€Š19.1 vs 14.2 ±â€Š10.2 days, P < 0.01), and length of pharmacological treatment (18.0 ±â€Š19.9 vs 9.0 ±â€Š10.2 days, P < 0.01) compared to those on the pediatric floor, respectively. Forty-seven infants were transferred from the NICU to the pediatric floor for the remainder of their hospital stay with a mean time on the pediatric floor of 17.4 ±â€Š14.5 days. After controlling for confounding, admission to the NICU was associated with an increased length of treatment of 12.6 days (95% confidence interval 8.3-16.8) and length of stay of 12.3 days (95% confidence interval 7.9-16.6). CONCLUSIONS: In our population, admission to the pediatric floor compared to the NICU was associated with a shorter length of stay, and a shorter length of pharmacological treatment. Our data suggest that caring for infants with NAS outside of the NICU setting has the potential to improve short-term outcomes and reduce associated costs.

Public reporting of quality data for stroke: is it measuring quality?

BACKGROUND AND PURPOSE: Public reporting of quality data is becoming more common and increasingly used to improve choices of patients, providers, and payers. We reviewed the scope and content of stroke data being reported to the public and how well it captures the quality of stroke care. METHODS: We performed a cross-sectional survey of all report cards within the Agency for Healthcare Research and Quality Report Card Compendium. Stroke quality data were categorized into one of 5 groups: structure, process, outcomes, utilization, and finances. We also determined the congruence of mortality ratings of New York hospitals provided by 2 different report cards. RESULTS: Of 221 available report cards, 19 (9%) reported quality information regarding stroke and 17 specifically addressed the quality of hospital-based stroke care. The most frequent data reported were utilization measures (n=15 report cards) and outcome measures (n=14 report cards). Data regarding finances (n=4), structure of care (n=2), and process of care (n=1) were reported infrequently. Ratings were incongruent in 61 of the 157 hospitals (39%) with the same hospital being rated below average on one report care and average on another in 44 hospitals. CONCLUSIONS: Publicly reported quality data pertaining to patients with stroke are incomplete, confusing, and inaccurate. Without further improvements and a better understanding of the needs and limitations of the many stakeholders, targeted transparency policies for stroke care may lead to worse quality and large economic losses.

Spatial and environmental correlates of organism colonization and infection in the neonatal intensive care unit.

OBJECTIVE: To examine organism colonization and infection in the neonatal intensive care unit as a result of environmental and spatial factors. STUDY DESIGN: A retrospective cohort of infants admitted between 2006 and 2015 (n = 11 428), to assess the relationship between location and four outcomes: methicillin-resistant Staphylococcus aureus (MRSA) colonization; culture-confirmed late-onset sepsis; and, if intubated, endotracheal tube colonization with Pseudomonas aeruginosa or Klebsiella pneumonia. Independent risk factors were identified with mixed-effects logistic regression models and Moran's I for spatial autocorrelation. RESULT: All four outcomes statistically clustered by location; neighboring colonization also influenced risk of MRSA (p < 0.05). For P. aeruginosa, being in a location with space for more medical equipment was associated with 2.61 times the odds of colonization (95% CrI: 1.19, 5.78). CONCLUSION: Extrinsic factors partially explained risk for neonatal colonization and infection. For P. aeruginosa, infection prevention efforts at locations with space for more equipment may lower future colonization.

A Network Model of Hand Hygiene: How Good Is Good Enough to Stop the Spread of MRSA?

BACKGROUND Simulation models have been used to investigate the impact of hand hygiene on methicillin-resistant Staphylococcus aureus (MRSA) transmission within the healthcare setting, but they have been limited by their ability to accurately model complex patient-provider interactions. METHODS Using a network-based modeling approach, we created a simulated neonatal intensive care unit (NICU) representing the potential for per-hour infant-infant MRSA transmission via the healthcare worker resulting in subsequent colonization. The starting prevalence of MRSA colonized infants varied from 2% to 8%. Hand hygiene ranged from 0% (none) to 100% (theoretical maximum), with an expected effectiveness of 88% inferred from literature. RESULTS Based on empiric care provided within a 1-hour period, the mean number of infant-infant MRSA transmissible opportunities per hour was 1.3. Compared to no hand hygiene and averaged across all initial colonization states, colonization was reduced by approximately 29%, 51%, 67%, 80%, and 86% for the respective levels of hygiene: 24%, 48%, 68%, 88%, and 100%. Preterm infants had a 61% increase in MRSA colonization, and mechanically ventilated infants had a 27% increase. CONCLUSIONS Even under optimal hygiene conditions, horizontal transmission of MRSA is possible. Additional prevention paradigms should focus on the most acute patients because they are at greatest risk. Infect Control Hosp Epidemiol 2017;38:945-952.

Maternal antibiotics and decreased periventricular leukomalacia in very low-birth-weight infants.

OBJECTIVE: To investigate the effect of maternal antibiotics, given in the predelivery period, on neonatal outcomes. DESIGN: Retrospective cohort study. SETTING: A single level 3 neonatal intensive care unit. PATIENTS: All infants with birth weights 1500 g or less cared for from July 1994 to July 2000 (n = 834) were included in the study. Mothers were classified as receiving antibiotics if they received any parenteral antibiotics in the predelivery period. Infants whose mothers received antibiotics were compared with infants whose mothers received no antibiotics. MAIN OUTCOME MEASURES: The main outcome variables studied included intraventricular hemorrhage (IVH), cystic periventricular leukomalacia (PVL), sepsis, and mortality. RESULTS: Of 834 mothers, 374 (45%) received antibiotics prior to delivery. On univariate analysis, there were no differences in the relative risk (RR) of mortality (1.26; 95% confidence interval [CI], 0.86-1.79) or grades 3 to 4 IVH (RR, 1.39; 95% CI, 0.82-1.90) between the antibiotics and no-antibiotics groups. Infants born to mothers receiving antibiotics had an increased risk of culture-proven sepsis (RR, 1.4; 95% CI, 1.02-1.64) and a decreased risk of cystic PVL (RR, 0.26; 95% CI, 0.09-0.79) compared with infants whose mothers did not receive antibiotics. After controlling for confounding variables, maternal antibiotics were not associated with a decrease in the risk of mortality (adjusted risk [AR], 1.0; 95% CI, 0.5-2.1), grades 3 to 4 IVH (AR, 1.0; 95% CI, 0.5-1.9), or sepsis (AR, 0.9; 95% CI, 0.7-1.4). However, the use of maternal antibiotics was associated with a decreased risk of developing cystic PVL (AR, 0.09; 95% CI, 0.02-0.5). CONCLUSIONS: In our population of very low-birth-weight infants, maternal antibiotics were associated with a decreased risk of cystic PVL. Maternal antibiotics do not change the risk of mortality, sepsis, or severe IVH.

The safety of hospital stroke care.

OBJECTIVES: To analyze medical errors and adverse events occurring in stroke patients and to provide insights into system or stroke-specific processes that can be modified to reduce the likelihood of error and patient harm. METHODS: We analyzed spontaneously reported errors and adverse events reported within a voluntary and mandatory event reporting system in stroke patients admitted to a 750-bed academic medical center over a 3.5-year period between July 1, 2001, and December 31, 2004. We determined the frequency of near misses and preventable adverse events by event type (medication, adverse clinical, and falls). We performed a central event analysis to determine the most likely cause of preventable adverse events. RESULTS: Of the 1,440 stroke patients admitted during the study period, 173 patients (12.0%) experienced an adverse event that was reported within an event-reporting system. Of the 176 events in 148 patients reported in the voluntary event reporting system, 72 were falls, 62 were medication events, and 42 were adverse clinical events. Of the 28 events in 25 patients reported in the mandatory event-reporting system, all were adverse clinical events and involved patient harm. Of the total 201 unique events (3 events were reported in both systems), 18 were near misses and 183 were adverse events. Of the 183 adverse events, 86 were preventable, 37 were not preventable, and 60 were indeterminate. Preventable adverse events involved drugs and situations commonly seen in the stroke population and occurred in all aspects of care delivery from thrombolytic management to end-of-life care. Of the 86 preventable adverse events, 37% (32/86) were transcription/documentation errors, 23% (20/86) were failure to perform a clinical task, 10% (9/86) were communication/handoff errors between providers, and 10% (9/86) were failed independent checks/calculations. CONCLUSIONS: Adverse events and errors occur frequently in stroke patients. A disease-specific approach to analyzing spontaneously reported events may help close the feedback loop on patient safety and improve the quality of care.

Using administrative data to improve compliance with mandatory state event reporting.

BACKGROUND: The New York Patient Occurrence and Tracking System (NYPORTS) is a mandatory adverse event reporting system that was redesigned in 1998. Analysis of the first full year of its use showed large regional and hospital variation in reporting frequency not due to hospital or case mix differences. In early 2001, New York State mandated that all hospitals conduct retrospective review for unreported adverse incidents for the previous 2 years. Hospitals could submit previously unreported incidents within a defined window without penalty. The hospital used an ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) analysis to screen for missed NYPORTS cases, to assist in focusing review resources. METHODS: NYPORTS categories were matched to corresponding combinations of inpatient ICD-9-CM diagnosis and procedure codes. Other variables considered included discharge disposition, primary or secondary coding position, readmissions, and NYPORTS exclusions. RESULTS: Among more than 60,000 discharges in 2 years, 5,500 records were identified for NYPORTS review based on the ICD-9-CM criteria; 211 cases had already been reported through normal reporting processes. Thirteen of the NYPORTS codes had a 30% or greater match rate to the ICD-9-CM codes, with an average "hit rate" of 56%. Five-hundred sixty reviews identified 187 (33.4%) reportable events for the same code the case was being screened for and 26 additional reportable events for a code other than the screening code. NYPORTS categories for procedure and operative-related occurrences had the highest yields. CONCLUSIONS: This retrospective effort helped identify previously unreported occurrences, increase institutional awareness of New York State's mandatory reporting process, and stimulate the redesign of our concurrent detection process.

Late-onset Mycobacterium abscessus sepsis in a very low birthweight premature infant: diagnostic and therapeutic challenges.

Late-onset sepsis (after 3 days of life) is a frequent a complication found in very low birth weight (VLBW, 1000 to 1500 g) premature infants. We report the second case of late-onset sepsis caused by an uncommon pathogen, Mycobacterium abscessus.