Overdiagnosis of Newborn Hyperbilirubinemia: A Natural Experiment in Quality Improvement Fundamentals.

Two hospitals noted increased newborn hyperbilirubinemia coinciding with an undisclosed total serum bilirubin (TSB) assay change. Clinicians rapidly applied quality improvement methodologies to ascertain increased jaundice evaluations, readmissions, and possible safety issues. Methods: In January 2020, 2 hospitals (A and B) transitioned to a new method of measuring TSB using a new clinical chemistry analyzer (Siemens Atellica CH), which measured TSB by vanadate oxidase assay instead of the previous diazo assay. Five affiliated hospitals (C-G) continued to utilize the diazo assay. This natural experiment led to a comparison of data across the 7 hospitals. We analyzed: (1) TSB levels, (2) hospital hyperbilirubinemia readmissions, and (3) paired TSB measurements comparing the diazo assay and vanadate oxidase method. Results: Compared to the 2019 baseline, Hospitals A and B had a significant increase in TSBs ≥17.0 mg/dl and TSBs ≥20 mg/dl in 2020; Hospitals C-G did not. Readmissions for phototherapy significantly increased in hospitals A and B in 2020 compared to 2019. Paired blood samples showed bias-elevated TSBs by vanadate assay compared to the diazo method. By 2021, the laboratory resumed processing TSB samples by diazo assay, and the frequency of elevated TSBs and hyperbilirubinemia readmissions returned to 2019 levels. Conclusions: Factitious TSB elevation related to an assay change significantly increased newborn hyperbilirubinemia evaluations and phototherapy readmissions. Imbedded quality improvement methodologies of careful structure, process, and outcomes review hastened resolution.

Discontinuation of Car Seat Tolerance Screening and Postdischarge Adverse Outcomes in Infants Born Preterm.

OBJECTIVE: To study the association between discontinuing predischarge car seat tolerance screening (CSTS) with 30-day postdischarge adverse outcomes in infants born preterm. STUDY DESIGN: Retrospective cohort study involving all infants born preterm from 2010 through 2021 who survived to discharge to home in a 14-hospital integrated health care system. The exposure was discontinuation of CSTS. The primary outcome was a composite rate of death, 911 call-triggered transports, or readmissions associated with diagnostic codes of respiratory disorders, apnea, apparent life-threatening event, or brief resolved unexplained events within 30 days of discharge. Outcomes of infants born in the periods of CSTS and after discontinuation were compared. RESULTS: Twelve of 14 hospitals initially utilized CSTS and contributed patients to the CSTS period; 71.4% of neonatal intensive care unit (NICU) patients and 26.9% of non-NICU infants were screened. All hospitals participated in the discontinuation period; 0.1% was screened. Rates of the unadjusted primary outcome were 1.02% in infants in the CSTS period (n = 21 122) and 1.06% after discontinuation (n = 20 142) (P = .76). The aOR (95% CI) was 0.95 (0.75, 1.19). Statistically insignificant differences between periods were observed in components of the primary outcome, gestational age strata, NICU admission status groups, and other secondary analyses. CONCLUSIONS: Discontinuation of CSTS in a large integrated health care network was not associated with a change in 30-day postdischarge adverse outcomes. CSTS's value as a standard predischarge assessment deserves further evaluation.

Umbilical cord milking in nonvigorous infants: a cluster-randomized crossover trial.

BACKGROUND: Delayed cord clamping and umbilical cord milking provide placental transfusion to vigorous newborns. Delayed cord clamping in nonvigorous newborns may not be provided owing to a perceived need for immediate resuscitation. Umbilical cord milking is an alternative, as it can be performed more quickly than delayed cord clamping and may confer similar benefits. OBJECTIVE: We hypothesized that umbilical cord milking would reduce admission to the neonatal intensive care unit compared with early cord clamping in nonvigorous newborns born between 35 and 42 weeks' gestation. STUDY DESIGN: This was a pragmatic cluster-randomized crossover trial of infants born at 35 to 42 weeks' gestation in 10 medical centers in 3 countries between January 2019 and May 2021. The centers were randomized to umbilical cord milking or early cord clamping for approximately 1 year and then crossed over for an additional year or until the required number of consented subjects was reached. Waiver of consent as obtained in all centers to implement the intervention. Infants were eligible if nonvigorous at birth (poor tone, pale color, or lack of breathing in the first 15 seconds after birth) and were assigned to umbilical cord milking or early cord clamping according to their birth hospital randomization assignment. The baseline characteristics and outcomes were collected following deferred informed consent. The primary outcome was admission to the neonatal intensive care unit for predefined criteria. The main safety outcome was hypoxic-ischemic encephalopathy. Data were analyzed by the intention-to-treat concept. RESULTS: Among 16,234 screened newborns, 1780 were eligible (905 umbilical cord milking, 875 early cord clamping), and 1730 had primary outcome data for analysis (97% of eligible; 872 umbilical cord milking, 858 early cord clamping) either via informed consent (606 umbilical cord milking, 601 early cord clamping) or waiver of informed consent (266 umbilical cord milking, 257 early cord clamping). The difference in the frequency of neonatal intensive care unit admission using predefined criteria between the umbilical cord milking (23%) and early cord clamping (28%) groups did not reach statistical significance (modeled odds ratio, 0.69; 95% confidence interval, 0.41-1.14). Umbilical cord milking was associated with predefined secondary outcomes, including higher hemoglobin (modeled mean difference between umbilical cord milking and early cord clamping groups 0.68 g/dL, 95% confidence interval, 0.31-1.05), lower odds of abnormal 1-minute Apgar scores (Apgar ≤3, 30% vs 34%, crude odds ratio, 0.72; 95% confidence interval, 0.56-0.92); cardiorespiratory support at delivery (61% vs 71%, modeled odds ratio, 0.57; 95% confidence interval, 0.33-0.99), and therapeutic hypothermia (3% vs 4%, crude odds ratio, 0.57; 95% confidence interval, 0.33-0.99). Moderate-to-severe hypoxic-ischemic encephalopathy was significantly less common with umbilical cord milking (1% vs 3%, crude odds ratio, 0.48; 95% confidence interval, 0.24-0.96). No significant differences were observed for normal saline bolus, phototherapy, abnormal 5-minute Apgar scores (Apgar ≤6, 15.7% vs 18.8%, crude odds ratio, 0.81; 95% confidence interval, 0.62-1.06), or a serious adverse event composite of death before discharge. CONCLUSION: Among nonvigorous infants born at 35 to 42 weeks' gestation, umbilical cord milking did not reduce neonatal intensive care unit admission for predefined criteria. However, infants in the umbilical cord milking arm had higher hemoglobin, received less delivery room cardiorespiratory support, had a lower incidence of moderate-to-severe hypoxic-ischemic encephalopathy, and received less therapeutic hypothermia. These data may provide the first randomized controlled trial evidence that umbilical cord milking in nonvigorous infants is feasible, safe and, superior to early cord clamping.

Implementing potentially better practices to improve neonatal outcomes after reducing postnatal dexamethasone use in infants born between 501 and 1250 grams.

OBJECTIVE: The purpose of this article is to describe how a neonatal intensive care unit (NICU) was able to reduce substantially the use of postnatal dexamethasone in infants born between 501 and 1250 g while at the same time implementing a group of potentially better practices (PBPs) in an attempt to decrease the incidence and severity of chronic lung disease (CLD). METHODS: This study was both a retrospective chart review and an ongoing multicenter evidence-based investigation associated with the Vermont Oxford Network Neonatal Intensive Care Quality Improvement Collaborative (NIC/Q 2000). The NICU specifically made the reduction of CLD and dexamethasone use a priority and thus formulated a list of PBPs that could improve clinical outcomes across 3 time periods: era 1, standard NICU care that antedated the quality improvement project; era 2, gradual implementation of the PBPs; and era 3, full implementation of the PBPs. All infants who had a birth weight between 501 and 1250 g and were admitted to the NICU during the 3 study eras were included (era 1, n = 134; era 2, n = 73; era 3, n = 83). As part of the NIC/Q 2000 process, the NICU implemented 3 primary PBPs to improve clinical outcomes related to pulmonary disease: 1) gentle, low tidal volume resuscitation and ventilation, permissive hypercarbia, increased use of nasal continuous positive airway pressure; 2) decreased use of postnatal dexamethasone; and 3) vitamin A administration. The total dexamethasone use, the incidence of CLD, and the mortality rate were the primary outcomes of interest. Secondary outcomes included the severity of CLD, total ventilator and nasal continuous positive airway pressure days, grades 3 and 4 intracranial hemorrhage, periventricular leukomalacia, stages 3 and 4 retinopathy of prematurity, necrotizing enterocolitis, pneumothorax, length of stay, late-onset sepsis, and pneumonia. RESULTS: The percentage of infants who received dexamethasone during their NICU admission decreased from 49% in era 1 to 22% in era 3. Of those who received dexamethasone, the median number of days of exposure dropped from 23.0 in era 1 to 6.5 in era 3. The median total NICU exposure to dexamethasone in infants who received at least 1 dose declined from 3.5 mg/kg in era 1 to 0.9 mg/kg in era 3. The overall amount of dexamethasone administered per total patient population decreased 85% from era 1 to era 3. CLD was seen in 22% of infants in era 1 and 28% in era 3, a nonsignificant increase. The severity of CLD did not significantly change across the 3 eras, neither did the mortality rate. We observed a significant reduction in the use of mechanical ventilation as well as a decline in the incidence of late-onset sepsis and pneumonia, with no other significant change in morbidities or length of stay. CONCLUSIONS: Postnatal dexamethasone use in premature infants born between 501 and 1250 g can be sharply curtailed without a significant worsening in a broad range of clinical outcomes. Although a modest, nonsignificant trend was observed toward a greater number of infants needing supplemental oxygen at 36 weeks' postmenstrual age, the severity of CLD did not increase, the mortality rate did not rise, length of stay did not increase, and other benefits such as decreased use of mechanical ventilation and fewer episodes of nosocomial infection were documented.