The Risks of Being Tiny: The Added Risk of Low Weight for Neonates Undergoing Congenital Heart Surgery.

The aims of this study were (1) to describe the additive risk of performing cardiac surgery in neonates born ≤ 2.0 kg, after accounting for the baseline risks of low birth weight, and (2) to describe the additive risk of being born ≤ 2.0 kg in neonates undergoing cardiac surgery. We used a risk difference analysis in a retrospective cohort, 2006-2016. Neonates born ≤ 2.0 kg undergoing congenital heart surgery during initial postnatal admission were included. Data were standardized alternatingly for birth weight and cardiac surgical risk using national population data to estimate the number of deaths expected had they not required cardiac surgery or were they of normal weight. Of 105 neonates ≤ 2 kg, median birth weight was 1.6 kg (IQR 1.3-1.8 kg). Median gestational age was 33 weeks (IQR 31-35 weeks). Observed operative mortality was 14.3%; 0% for neonates ≤ 1.0 kg (CI 0-33.6%), 20.6% for neonates > 1.0-1.5 kg (CI 8.7-37.9%), and 12.9% for neonates > 1.5-2.0 kg (CI 5.7-23.9%). Among neonates ≤ 2.0 kg not undergoing cardiac surgery, expected mortality was 4.8% (CI 1.6-10.8); cardiac surgery increased the risk of mortality 9.5% (CI 1.7-17.4%). Conversely, the expected risk for normal birth weight neonates undergoing cardiac surgery was 5.7% (CI 2.1-12.0%); low birth weight increased the risk of mortality 8.6% (CI 0.5-16.6%). To continue making advancements in cardiac surgery, we must understand that the rate of mortality observed in normal weight infants is not a realistic target and that, despite advances, the risk attributable to the surgery remains higher among low birth weight patients.

Safety and Varicella Outcomes in In Utero-Exposed Newborns and Preterm Infants Treated With Varicella Zoster Immune Globulin (VARIZIG): A Subgroup Analysis of an Expanded-Access Program.

BACKGROUND: Infants exposed to varicella zoster virus (VZV) in utero ≤5 days before or ≤48 hours after delivery and preterm infants are at high risk for varicella complications. An expanded-access program assessed varicella outcomes after administration of varicella zoster immune globulin (human) (VARIZIG) in a real-world setting. METHODS: In this open-label, expanded-access program, high-risk infants received ≤125 IU/10 kg of VARIZIG (NCT00338442). VZV outcomes and safety were assessed. RESULTS: There were 43 newborns exposed to VZV in utero and 80 preterm infants exposed to VZV; >80% received VARIZIG within 96 hours of reported exposure. When varicella outcomes were available, varicella occurred in 7 of 38 (18%) in utero-exposed newborns and zero of 65 preterm infants. Varicella-related complications were reported in 3 in utero-exposed newborns (3 with >100 lesions, 1 each with encephalitis and pneumonia). Adverse events were reported for 16% of in utero-exposed newborns and 25% of preterm infants, but few were considered related to VARIZIG. There were no deaths attributable to varicella or VARIZIG. CONCLUSIONS: Varicella incidence and morbidity were low in in utero-exposed infants and zero in preterm infants who received prophylactic VARIZIG. There were few VARIZIG-related safety concerns.

Varicella zoster immune globulin (VARIZIG) administration up to 10 days after varicella exposure in pregnant women, immunocompromised participants, and infants: Varicella outcomes and safety results from a large, open-label, expanded-access program.

INTRODUCTION: Despite vaccination, there were more than 100,000 annual cases of varicella in the United States in 2013-2014. Individuals at highest risk of developing severe or complicated varicella include immunocompromised people, preterm infants, and pregnant women. Varicella zoster immune globulin (human) (VARIZIG) is recommended by the CDC for postexposure prophylaxis to prevent or attenuate varicella-zoster virus infection in high-risk individuals. Contemporary information on administration of VARIZIG is limited. METHODS: This open-label, expanded-access program provided VARIZIG to physician-identified, high-risk participants exposed to varicella. Participants included immunocompromised children/adults, infants (preterm, newborns whose mothers had varicella onset within 5 days before or 2 days after delivery, and those aged <1 year), and pregnant women. VARIZIG (125 IU/10 kg [up to 625 IU]) was administered intramuscularly, ideally within 96 hours, but up to 10 days, postexposure. Incidence of varicella rash and severity (>100 pox, pneumonia, or encephalitis) were assessed up to 42 days after administration. RESULTS: The varicella outcome population (n = 507) included 263 immunocompromised participants (32 adults, 231 children), 137 pregnant women, 105 infants, and 2 healthy adults with no history of varicella. Varicella incidence was 4.5% in immunocompromised participants, 7.3% in pregnant women, and 11.5% in infants. The incidence of varicella was similar when comparing VARIZIG administration ≤ 96 hours vs > 96 hours (up to 10 days) postexposure in the entire population (6.2% vs. 9.4%, respectively), and also in each subgroup. Of 34 participants with varicella, 5 developed > 100 pox and 1 developed pneumonia and encephalitis. There were no product-related deaths and only 1 serious adverse event (serum sickness) considered probably related to VARIZIG. CONCLUSION: Postexposure administration of VARIZIG was associated with low rates of varicella in high-risk participants, regardless of when administered within 10 days postexposure. VARIZIG was well-tolerated and safe in high-risk participants.

The effects of postoperative hematocrit on shunt occlusion for neonates undergoing single ventricle palliation.

OBJECTIVES: Our primary objective was to test the effects of first postoperative hematocrit on early shunt occlusion for children undergoing systemic to pulmonary artery shunt placement. Because any intervention to reduce shunt occlusion is only beneficial if it reduces mortality or is, at least, mortality neutral, we also tested the effects of first postoperative hematocrit on in-hospital mortality. METHODS: We conducted a retrospective study on all neonates who underwent primary systemic to pulmonary artery shunt placement, with or without a Norwood/Damus-Kaye-Stansel procedure, at Columbia University Medical Center between January 2010 and July 2015. Univariable regression was used to test the effects of first postoperative hematocrit on early shunt occlusion and 30-day mortality, clustering standard errors by surgeon. In secondary analyses, we also tested associations between red blood cell transfusion volumes in the first 24 postoperative hours and first postoperative hematocrit, shunt occlusion, and mortality. RESULTS: Eighty infants met inclusion criteria. Median initial postoperative hematocrit was 41.7% (interquartile range, 37.9-46.0). Six infants (7.5%) died. Four infants (5.0%) died within the first 30 days. Five infants (6.3%) experienced early shunt occlusion. No children with early shunt occlusion died. In univariable models, for every 5 additional percentage points of hematocrit, an infant's odds of early shunt occlusion more than doubled (odds ratio, 2.70; P = .009). The odds of all-cause 30-day mortality remained unchanged. CONCLUSIONS: Higher postoperative hematocrit levels are associated with early shunt occlusions in infants undergoing primary systemic to pulmonary artery shunt placement. Multicenter investigations are warranted to validate these findings and to determine ideal postoperative hematocrit targets for this population.

Congenital Parvovirus B19 Infection: Persistent Viremia and Red Blood Cell Aplasia.

We describe a case of fetal parvovirus B19 infection resulting in preterm birth and leading to hydrops fetalis requiring multiple in utero transfusions. The infant developed chronic postnatal anemia responsive to intravenous immunoglobulin therapy. Serum viral load decreased after immunoglobulin treatment but remained detectable for over 1 year.

Development of an antimicrobial stewardship intervention using a model of actionable feedback.

We describe the development of an audit and feedback intervention to improve antibiotic prescribing in the neonatal intensive care unit (NICU) using a theoretical framework. Participants included attending physicians, neonatal fellows, pediatric residents, and nurse practitioners. The intervention was based on the "model of actionable feedback" which emphasizes that feedback should be timely, individualized, nonpunitive, and customized to be effective. We found that real-time feedback could not be provided for the parameters established in this study, as we had to collect and analyze numerous data elements to assess appropriate initiation and continuation of antibiotics and required longer intervals to examine trends in antibiotic use. We learned during focus groups that NICU clinicians strongly resisted assigning individual responsibility for antibiotic prescribing as they viewed this as a shared responsibility informed by each patient's laboratory data and clinical course. We were able to create a non-punitive atmosphere thanks to written informed consent from NICU attendings and assurance from leadership that prescribing practices would not be used to assess job performance. We provided customized, meaningful feedback integrating input from the participants. Adapting the principles of the "model of actionable feedback" to provide feedback for antimicrobial prescribing practices proved challenging in the NICU setting.