Characteristics and outcomes of a multi-institution cohort of infants with necrotizing enterocolitis totalis.

OBJECTIVE: To characterize the presentation, management and outcomes of infants with necrotizing enterocolitis totalis (tNEC) vs surgical non-totalis NEC (sNEC). STUDY DESIGN: This retrospective study identified infants undergoing surgery for NEC through The Children's Hospitals Neonatal Database. Demographic, surgical and mortality characteristics were compared. RESULTS: Of 1059 infants, 161 (15.2%) had tNEC. Perinatal characteristics did not differ. tNEC infants were older and were less likely to have pneumoperitoneum at referral (5.6% vs 13.1%, p < 0.001) or intestinal perforation at surgery (38.5% vs 66.7%, p < 0.001). Infants with tNEC were more acidotic preoperatively (7.1, [IQR 7, 7.3] vs 7.3, [IQR 7.2, 7.4], p < 0.001). Mortality was 96.9% for tNEC and 26.5% for sNEC (p < 0.001). tNEC cases varied by center, accounting for 0-43% of all surgical NEC cases. CONCLUSIONS: Mortality is high for tNEC infants, who present at older age, with greater illness severity but are less likely to have intestinal perforation than sNEC infants.

STEPP IN: A Multicenter Quality Improvement Collaborative Standardizing Postoperative Handoffs.

OBJECTIVE: To reduce care failures by 30% through implementation of standardized communication processes for postoperative handoff in NICU patients undergoing surgery over 12 months and sustained over 6 months. METHODS: Nineteen Children's Hospitals Neonatal Consortium centers collaborated in a quality improvement initiative to reduce postoperative care failures in a surgical neonatal setting by decreasing respiratory care failures and all other communication failures. Evidence-based clinical practice recommendations and a collaborative framework supported local teams' implementation of standardized postoperative handoff communication. Process measures included compliance with center-defined handoff staff presence, use of center-defined handoff tool, and the proportion of handoffs with interruptions. Participant handoff satisfaction was the balancing measure. Baseline data were collected for 8 months, followed by a 12-month action phase and 7-month sustain phase. RESULTS: On average, 181 postoperative handoffs per month were monitored across sites, and 320 respondents per month assessed the handoff process. Communication failures specific to respiratory care decreased by 73.2% (8.2% to 4.6% and with a second special cause signal to 2.2%). All other communication care failures decreased by 49.4% (17% to 8.6%). Eighty-four percent of participants reported high satisfaction. Compliance with use of the handoff tool and required staff attendance increased whereas interruptions decreased over the project time line. CONCLUSIONS: Team engagement within a quality improvement framework had a positive impact on the perioperative handoff process for high-risk surgical neonates. We improved care as demonstrated by a decrease in postoperative care failures while maintaining high provider satisfaction.

Mucous Fistula Refeeding Promotes Earlier Enteral Autonomy in Infants With Small Bowel Resection.

OBJECTIVE: Infants requiring intestinal resection because of necrotizing enterocolitis (NEC) or small bowel atresia (SBA) may benefit from mucous fistula refeeding (MFR) of enterostomy output to improve nutrition and bowel adaptation before reanastomosis. Previous series demonstrated improved outcomes with MFR but did not account for varied patient characteristics as potential sources of bias. We performed a cohort analysis using multivariable adjusted models to compare outcomes of patients with and without MFR. METHODS: Retrospective chart review was performed for patients with NEC or SBA and small bowel resection with enterostomy and MF. Demographic and outcome data was compared between MFR and non-MFR groups using adjusted multivariable analysis for potential confounding variables. RESULTS: MFR was performed in 65 of 101 patients (64%), including 45 of 75 patients with NEC and 20 of 26 patients with SBA. Reasons for not receiving MFR included bowel stricture, technical limitation, or not otherwise specified. NEC patients receiving MFR had 14 fewer days to achieve full enteral feeds after intestinal reconnection, 22 fewer days of parenteral nutrition, lower peak direct bilirubin by 2.4 mg/dL, and 77% less odds of ursodiol use (all P < 0.01). SBA patients had similar trends not reaching statistical significance. Growth parameters were improved in MFR groups. There were no complications or increased infections from MFR. CONCLUSIONS: This study suggests that MFR safely improves nutritional outcomes in infants with intestinal resection, related to decreased total parenteral nutrition (TPN) dependence and earlier enteral autonomy.

Use of Palliative Care Consultation Services for Infants With Life-Threatening Conditions in a Metropolitan Hospital.

BACKGROUND: Palliative care is becoming an important component for infants with life-limiting or life-threatening conditions and their families. Yet palliative care practices appear to be inconsistent and sporadically used for infants. PURPOSE: The purpose of this study was to describe the use of an established pediatric palliative care team for seriously ill infants in a metropolitan hospital. METHODS: This was a retrospective medical record review. FINDINGS: The population included 64 infants who were admitted to a level IV neonatal intensive care unit (NICU) and then died during hospitalization between January 2015 and December 2016. Most infants died in an ICU (n = 63, 95%), and only 20 infants (31%) received palliative care consultation. Most common reasons for consultation were care coordination, defining goals of care and end-of-life planning, and symptom management. IMPLICATIONS FOR PRACTICE: Palliative care consultation at this institution did not change the course of end-of-life care. Interventions provided by the ICU team to infants surrounding end of life were similar to those in infants receiving palliative care services from the specialists. Our findings may be useful for developing guidelines regarding how to best utilize palliative care services for infants with life-threatening conditions who are admitted to an ICU. IMPLICATIONS FOR RESEARCH: These finding support continued research in neonatal palliative care, more specifically the impact of palliative care guidelines and algorithms.

STEPP IN: Working Together to Keep Infants Warm in the Perioperative Period.

OBJECTIVES: Reduce postoperative hypothermia by up to 50% over a 12-month period in children's hospital NICUs and identify specific clinical practices that impact success. METHODS: Literature review, expert opinion, and benchmarking were used to develop clinical practice recommendations for maintaining perioperative euthermia that included the following: established euthermia before transport to the operating room (OR), standardized practice for maintaining euthermia on transport to and from the OR, and standardized practice to prevent intraoperative heat loss. Process measures were focused on maintaining euthermia during these time points. The outcome measure was the proportion of patients with postoperative hypothermia (temperature ≤36°C within 30 minutes of a return to the NICU or at the completion of a procedure in the NICU). Balancing measures were the proportion of patients with postoperative temperature >38°C or the presence of thermal burns. Multivariable logistic regression was used to identify key practices that improved outcome. RESULTS: Postoperative hypothermia decreased by 48%, from a baseline of 20.3% (January 2011 to September 2013) to 10.5% by June 2015. Strategies associated with decreased hypothermia include >90% compliance with patient euthermia (36.1-37.9°C) at times of OR arrival (odds ratio: 0.58; 95% confidence interval [CI]: 0.43-0.79; P < .001) and OR departure (odds ratio: 0.0.73; 95% CI: 0.56-0.95; P = .017) and prewarming the OR ambient temperature to >74°F (odds ratio: 0.78; 95% CI: 0.62-0.999; P = .05). Hyperthermia increased from a baseline of 1.1% to 2.2% during the project. No thermal burns were reported. CONCLUSIONS: Reducing postoperative hypothermia is possible. Key practices include prewarming the OR and compliance with strategies to maintain euthermia at select time points throughout the perioperative period.

Inotrope Needs in Neonates Requiring Extracorporeal Membrane Oxygenation for Respiratory Failure.

OBJECTIVE: To evaluate how inotropic requirements in neonates with respiratory failure are affected by extracorporeal membrane oxygenation (ECMO) mode and whether high requirements predict mortality. STUDY DESIGN: This retrospective chart review included all neonates undergoing ECMO for primary respiratory failure from 2010 to 2016 at a single institution. The vasoactive inotropy score (VIS) was calculated as described in the literature. Data were analyzed with descriptive statistics and univariate analyses. RESULTS: Of the 110 identified neonates, 96 underwent venovenous (VV) (87%), 11 (10%) venoarterial, and 3 (3%) converted from VV to venoarterial. The median precannulation VIS score was 33.02 for patients who underwent VV compared with 28.93 for venoarterial (P = .25) and 15 for infants converted. VIS decreased dramatically by 4 hours of ECMO in both groups. The VIS before cannulation was similar in survivors and nonsurvivors, but was significantly higher in nonsurvivors after 24 hours of ECMO (median VIS, 12 [IQR, 8-25] vs 8 [IQR, 3.0-14.5]; P = .035) and at decannulation (10 [IQR, 7-19] vs 3 [IQR, 0-7]; P < .001). CONCLUSIONS: Neonates with respiratory failure can be successfully managed on VV ECMO even with considerable vasoactive requirements. Vasoactive requirement after 24 hours of ECMO was predictive of mortality.

Does the initial surgery for necrotizing enterocolitis matter? Comparative outcomes for laparotomy vs. peritoneal drain as initial surgery for necrotizing enterocolitis in infants <1000 g birth weight.

PURPOSE: Quantify short-term outcomes associated with initial surgery [laparotomy (LAP) vs. peritoneal drain (PD)] for necrotizing enterocolitis (NEC) in extremely-low-birth-weight (ELBW) infants. METHODS: Using the Children's Hospitals Neonatal Database, we identified ELBW infants <32 weeks' gestation with surgical NEC (sNEC). Unadjusted and multivariable regression analyses were used to estimate the associations between LAP (or PD) and death/short bowel syndrome (SBS) and length of stay (LOS). RESULTS: LAP was the more common initial procedure for sNEC (n = 359/528, 68%). Infants receiving LAP were older and heavier. Initial procedure was unrelated to death/SBS in both bivariate (LAP: 43% vs PD: 46%, p = 0.573) and multivariable analyses (OR = 0.89, 95% CI = 0.57, 1.38, p = 0.6). LAP was inversely related to mortality (29% vs. 41%, p < 0.007) in bivariate analysis, but not significant in multivariable analysis accounting for markers of preoperative illness severity. However, the association between LAP and SBS (14% vs. 5%, p = 0.012) remained significant in multivariable analyses (adjusted OR = 2.25, p = 0.039). LOS among survivors was unrelated to the first surgical procedure in multivariable analysis. CONCLUSION: ELBW infants who undergo LAP as the initial operative procedure for sNEC may be at higher risk for SBS without a clear in-hospital survival advantage or shorter hospitalization. LEVEL OF EVIDENCE: Level II.

Sustaining SLUG Bug CLABSI Reduction: Does Sterile Tubing Change Technique Really Work?

OBJECTIVES: To evaluate the ability to sustain and further reduce central line-associated bloodstream infection (CLABSI) rates in NICUs participating in a multicenter CLABSI reduction collaborative and to assess the impact of the sterile tubing change (TC) technique as an important component in CLABSI reduction. METHODS: A multi-institutional quality improvement collaborative lowered CLABSI rates in level IV NICUs over a 12-month period. During the 19-month sustain phase, centers were encouraged to monitor and report compliance measures but were only required to report the primary outcome measure of the CLABSI rate. Four participating centers adopted the sterile TC technique during the sustain phase as part of a local Plan-Do-Study-Act cycle. RESULTS: The average aggregate baseline NICU CLABSI rate of 1.076 CLABSIs per 1000 line days was sustained for 19 months across 17 level IV NICUs from January 2013 to July 2014. Four centers transitioning from the clean to the sterile TC technique during the sustain phase had a 64% decrease in CLABSI rates from the baseline (1.59 CLABSIs per 1000 line days to 0.57 CLABSIs per 1000 line days). CONCLUSIONS: Sustaining low CLABSI rates in a multicenter collaborative is feasible with team engagement and ongoing collaboration. With these results, we further demonstrate the positive impact of the sterile TC technique in CLABSI reduction efforts.

Orchestrated Testing.

Health care quality improvement collaboratives implement care bundles to target critical parts of a complex system to improve a specific health outcome. The quantitative impact of each component of the care bundle is often unknown. Orchestrated testing (OT) is an application of planned experimentation that allows simultaneous examination of multiple practices (bundle elements) to determine which intervention or combination of interventions affects the outcome. The purpose of this article is to describe the process needed to design and implement OT methodology for improvement collaboratives. Examples from a multicenter collaborative to reduce central line-associated bloodstream infections highlight the practical application of this approach. The key components for implementation of OT are the following: (1) define current practice and evidence, (2) develop a factorial matrix and calculate power, (3) formulate structure for engagement, (4) analyze results, and (5) replicate findings.

Adult Outcomes After Newborn Respiratory Failure Treated With Extracorporeal Membrane Oxygenation.

OBJECTIVE: To describe the outcome of young adults treated for hypoxemic respiratory failure with extracorporeal membrane oxygenation as neonates. DESIGN: The study was designed as a multisite, cross sectional survey. SETTING: The survey was completed electronically or on paper by subjects and stored in a secure data base. SUBJECTS: Subjects were surviving neonatal extracorporeal membrane oxygenation patients from eight institutions who were18 years old or older. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: A questionnaire modified from the 2011 Behavioral Risk Factor Surveillance System and the 2011 National Health Interview Survey with additional unique questions was completed by subjects. Results were compared to age-matched national Behavioral Risk Factor Surveillance System and National Health Interview Survey data. One hundred and forty-six subjects participated (8.9% of eligible candidates). The age at questionnaire submission was 23.7 ± 2.89 years. Subjects differed statistically from national cohorts by being more satisfied with life (93% vs 84.2%); more educated (some college or degree; 80.1% vs 57.7%); more insured for healthcare (89.7% vs 72.3%); less frequent users of healthcare in the last 12 months (47.3% vs 58.2%); more limited because of physical, mental, and developmental problems (19.9% vs 10.9%); and having more medical complications. Furthermore, learning problems occurred in 29.5% of the study cohort. The congenital diaphragmatic hernia group was generally less healthy and less well educated, but equally satisfied with life. Perinatal variables contributed little to outcome prediction. CONCLUSIONS: Most young adult survivors in this study cohort treated with extracorporeal membrane oxygenation as neonates are satisfied with their lives, working and/or in college, in good health and having families. These successes are occurring despite obstacles involving health issues such as asthma, attention deficit disorder, learning difficulties, and vision and hearing problems; this is especially evident in the congenital diaphragmatic hernia cohort. Selection bias inherent in such a long-term study may limit generalizability, and it is imperative to note that our sample may not be representative of the whole.

Growth Outcomes of Preterm Infants Exposed to Different Oxygen Saturation Target Ranges from Birth.

OBJECTIVE: To test whether infants randomized to a lower oxygen saturation (peripheral capillary oxygen saturation [SpO2]) target range while on supplemental oxygen from birth will have better growth velocity from birth to 36 weeks postmenstrual age (PMA) and less growth failure at 36 weeks PMA and 18-22 months corrected age. STUDY DESIGN: We evaluated a subgroup of 810 preterm infants from the Surfactant, Positive Pressure, and Oxygenation Randomized Trial, randomized at birth to lower (85%-89%, n = 402, PMA 26 ± 1 weeks, birth weight 839 ± 186 g) or higher (91%-95%, n = 408, PMA 26 ± 1 weeks, birth weight 840 ± 191 g) SpO2 target ranges. Anthropometric measures were obtained at birth, postnatal days 7, 14, 21, and 28; then at 32 and 36 weeks PMA; and 18-22 months corrected age. Growth velocities were estimated with the exponential method and analyzed with linear mixed models. Poor growth outcome, defined as weight <10th percentile at 36 weeks PMA and 18-22 months corrected age, was compared across the 2 treatment groups by the use of robust Poisson regression. RESULTS: Growth outcomes including growth at 36 weeks PMA and 18-22 months corrected age, as well as growth velocity were similar in the lower and higher SpO2 target groups. CONCLUSION: Targeting different oxygen saturation ranges between 85% and 95% from birth did not impact growth velocity or reduce growth failure in preterm infants.

Respiratory Decompensation and Immunization of Preterm Infants.

BACKGROUND: Concern for respiratory decompensation after immunization in premature infants, particularly those with bronchopulmonary dysplasia (BPD), may lead to delayed and altered immunization schedules. METHODS: A retrospective cohort of premature infants at <32 weeks' gestational age cared for in a tertiary level 4 NICU and immunized during their hospital stay were evaluated for respiratory decompensation within 72 hours of immunization. Respiratory measurements including change in respiratory support, mean fraction of inspired oxygen, and apnea, bradycardia, and desaturation events were compared between those infants with BPD and those without. The primary outcome was the difference in respiratory decompensation defined as a composite of increased respiratory support or increased fraction of inspired oxygen ≥10% within 72 hours of immunization. RESULTS: Of 403 infants admitted to the NICU and immunized, 240 met the study criteria. Of those infants, 172 had a diagnosis of BPD. There was no difference in the primary outcome of respiratory decompensation after immunization between groups (P = .65). There was also no significant difference in apnea, bradycardia, and desaturation events between groups (P = .51). CONCLUSIONS: In this cohort, respiratory decompensation requiring clinical intervention after immunization of preterm infants both with and without BPD was uncommon and not significantly different between groups. Consideration for immunization of this vulnerable population should not be delayed out of concern for clinical deterioration.

SLUG Bug: Quality Improvement With Orchestrated Testing Leads to NICU CLABSI Reduction.

OBJECTIVE: Reduce central line-associated bloodstream infection (CLABSI) rates 15% over 12 months in children's hospital NICUs. Use orchestrated testing as an approach to identify important CLABSI prevention practices. METHODS: Literature review, expert opinion, and benchmarking were used to develop clinical practice recommendations for central line care. Four existing CLABSI prevention strategies (tubing change technique, hub care monitoring, central venous catheter access limitation, and central venous catheter removal monitoring) were identified for study. We compared the change in CLABSI rates from baseline throughout the study period in 17 participating centers. Using orchestrated testing, centers were then placed into 1 of 8 test groups to identify which prevention practices had the greatest impact on CLABSI reduction. RESULTS: CLABSI rates decreased by 19.28% from 1.333 to 1.076 per 1000 line-days. Six of the 8 test groups and 14 of the 17 centers had decreased infection rates; 16 of the 17 centers achieved >75% compliance with process measures. Hub scrub compliance monitoring, when used in combination with sterile tubing change, decreased CLABSI rates by 1.25 per 1000 line-days. CONCLUSIONS: This multicenter improvement collaborative achieved a decrease in CLABSI rates. Orchestrated testing identified infection prevention practices that contribute to reductions in infection rates. Sterile tubing change in combination with hub scrub compliance monitoring should be considered in CLABSI reduction efforts.

Interdisciplinary teamwork and the power of a quality improvement collaborative in tertiary neonatal intensive care units.

Significant gaps in healthcare quality and outcomes can be reduced via quality improvement collaboratives (QICs), which improve care by leveraging data and experience from multiple organizations.The Children's Hospital Neonatal Consortium Collaborative Initiatives for Quality Improvement team developed an infrastructure for neonatal QICs. We describe the structure and components of an effective multi-institutional neonatal QIC that implemented the "SLUG Bug" project designed to reduce central line-associated bloodstream infections (CLABSIs).The operational infrastructure of SLUG Bug involved 17 tertiary care neonatal intensive care units with a goal to reduce CLABSI in high-risk neonates. Clinical Practice Recommendations were produced, and the Institute of Healthcare Improvement Breakthrough Series provided the framework for the collaborative. Process measures studied the effectiveness of the collaborative structure.CLABSI rates decreased by 20% during a 12-month study period. Compliance bundle reporting exceeded 80%. A QIC score of 2.5 or more ("improvement") was achieved by 94% of centers and a score 4 or more ("significant improvement") was achieved by 35%.Frequent interactive project meetings, well-defined project metrics, continual shared learning opportunities, and individual team coaching were key QIC success components. Through a coordinated approach and committed leadership, QICs can effectively implement change and improve the care of neonates with complex diagnoses and rare diseases.

The association of type of surgical closure on length of stay among infants with gastroschisis born≥34 weeks' gestation.

BACKGROUND/PURPOSE: The optimal surgical approach in infants with gastroschisis (GS) is unknown. The purpose of this study was to estimate the association between staged closure and length of stay (LOS) in infants with GS. DESIGN/METHODS: We used the Children's Hospital Neonatal Database to identify surviving infants with GS born ≥34 weeks' gestation referred to participating NICUs. Infants with complex GS, bowel atresia, or referred after 2 days of age were excluded. The primary outcome was LOS; multivariable linear regression was used to quantify the relationship between staged closure and LOS. RESULTS: Among 442 eligible infants, staged closure occurred in 68.1% and was associated with an increased median LOS relative to odds ration (OR):primary closure (37 vs. 28 days, p<0.001). This association persisted in the multivariable equation (ß=1.35, 95% CI: 1.21, 1.52, p<0.001) after adjusting for the presence of necrotizing enterocolitis, short bowel syndrome, and central-line associated bloodstream infections. CONCLUSIONS: In this large, multicenter cohort of infants with GS, staged closure was independently associated with increased LOS. These data can be used to enhance antenatal and pre-operative counseling and also suggest that some infants who receive staged closure may benefit from primary repair.

Target ranges of oxygen saturation in extremely preterm infants.

BACKGROUND: Previous studies have suggested that the incidence of retinopathy is lower in preterm infants with exposure to reduced levels of oxygenation than in those exposed to higher levels of oxygenation. However, it is unclear what range of oxygen saturation is appropriate to minimize retinopathy without increasing adverse outcomes. METHODS: We performed a randomized trial with a 2-by-2 factorial design to compare target ranges of oxygen saturation of 85 to 89% or 91 to 95% among 1316 infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. The primary outcome was a composite of severe retinopathy of prematurity (defined as the presence of threshold retinopathy, the need for surgical ophthalmologic intervention, or the use of bevacizumab), death before discharge from the hospital, or both. All infants were also randomly assigned to continuous positive airway pressure or intubation and surfactant. RESULTS: The rates of severe retinopathy or death did not differ significantly between the lower-oxygen-saturation group and the higher-oxygen-saturation group (28.3% and 32.1%, respectively; relative risk with lower oxygen saturation, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P=0.21). Death before discharge occurred more frequently in the lower-oxygen-saturation group (in 19.9% of infants vs. 16.2%; relative risk, 1.27; 95% CI, 1.01 to 1.60; P=0.04), whereas severe retinopathy among survivors occurred less often in this group (8.6% vs. 17.9%; relative risk, 0.52; 95% CI, 0.37 to 0.73; P<0.001). There were no significant differences in the rates of other adverse events. CONCLUSIONS: A lower target range of oxygenation (85 to 89%), as compared with a higher range (91 to 95%), did not significantly decrease the composite outcome of severe retinopathy or death, but it resulted in an increase in mortality and a substantial decrease in severe retinopathy among survivors. The increase in mortality is a major concern, since a lower target range of oxygen saturation is increasingly being advocated to prevent retinopathy of prematurity. (ClinicalTrials.gov number, NCT00233324.)