Effect of Early vs Late Inguinal Hernia Repair on Serious Adverse Event Rates in Preterm Infants: A Randomized Clinical Trial.

Importance: Inguinal hernia repair in preterm infants is common and is associated with considerable morbidity. Whether the inguinal hernia should be repaired prior to or after discharge from the neonatal intensive care unit is controversial. Objective: To evaluate the safety of early vs late surgical repair for preterm infants with an inguinal hernia. Design, Setting, and Participants: A multicenter randomized clinical trial including preterm infants with inguinal hernia diagnosed during initial hospitalization was conducted between September 2013 and April 2021 at 39 US hospitals. Follow-up was completed on January 3, 2023. Interventions: In the early repair strategy, infants underwent inguinal hernia repair before neonatal intensive care unit discharge. In the late repair strategy, hernia repair was planned after discharge from the neonatal intensive care unit and when the infants were older than 55 weeks' postmenstrual age. Main Outcomes and Measures: The primary outcome was occurrence of any prespecified serious adverse event during the 10-month observation period (determined by a blinded adjudication committee). The secondary outcomes included the total number of days in the hospital during the 10-month observation period. Results: Among the 338 randomized infants (172 in the early repair group and 166 in the late repair group), 320 underwent operative repair (86% were male; 2% were Asian, 30% were Black, 16% were Hispanic, 59% were White, and race and ethnicity were unknown in 9% and 4%, respectively; the mean gestational age at birth was 26.6 weeks [SD, 2.8 weeks]; the mean postnatal age at enrollment was 12 weeks [SD, 5 weeks]). Among 308 infants (91%) with complete data (159 in the early repair group and 149 in the late repair group), 44 (28%) in the early repair group vs 27 (18%) in the late repair group had at least 1 serious adverse event (risk difference, -7.9% [95% credible interval, -16.9% to 0%]; 97% bayesian posterior probability of benefit with late repair). The median number of days in the hospital during the 10-month observation period was 19.0 days (IQR, 9.8 to 35.0 days) in the early repair group vs 16.0 days (IQR, 7.0 to 38.0 days) in the late repair group (82% posterior probability of benefit with late repair). In the prespecified subgroup analyses, the probability that late repair reduced the number of infants with at least 1 serious adverse event was higher in infants with a gestational age younger than 28 weeks and in those with bronchopulmonary dysplasia (99% probability of benefit in each subgroup). Conclusions and Relevance: Among preterm infants with inguinal hernia, the late repair strategy resulted in fewer infants having at least 1 serious adverse event. These findings support delaying inguinal hernia repair until after initial discharge from the neonatal intensive care unit. Trial Registration: ClinicalTrials.gov Identifier: NCT01678638.

Dermal Abrasion Experienced as an Adverse Effect of the EZ-IO(®).

BACKGROUND: In 2007, an update was released to the pediatric and neonatal septic shock guidelines, which emphasized early use of therapies, specifically, first-hour fluid resuscitation and inotrope therapy. This has led to increased use of intraosseous (IO) access as a source of vascular access. Previously, IO access could be obtained only via a manual IO placement. New semi-automatic devices, such as EZ-IO(®) (Vidacare, Shavano Park, TX), allow for safer and quicker IO access. Data support the use of semi-automatic devices during the acute resuscitation period. CASE REPORT: The patient was a 7-month old girl with VACTERL association (Vertebral defects, Anal atresia, Cardiac defects, Tracheo-Esophageal fistula, Renal anomalies, Limb abnormalities) and complex past medical history. The patient experienced a "choking episode," which led to subsequent apnea and cyanosis. The patient presented in shock to a local pediatric emergency department. After multiple unsuccessful intravenous line attempts, IO access was obtained using the EZ-IO(®). Once in the pediatric intensive care unit with venous access, the IO device was removed and the site had "red bulls-eye target shape" damage to the skin, which appeared consistent with the EZ-IO(®) flange. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: IO device use is increasing due to the most recent pediatric and neonatal septic shock guidelines, which emphasize first-hour fluid resuscitation and inotrope therapy. It is vital that emergency physicians be aware of the adverse effects of semi-automatic IO devices, including dermal abrasion, which has not been reported previously. With proper training and familiarity, it is possible to avoid dermal abrasion as an adverse effect of the semi-automatic IO device.

Pregnancy outcomes after implementation of an induction of labor care pathway.

BACKGROUND: Induction of labor is common; however, the optimum clinical strategy for induction of labor is less clear. Variations in clinical practices related to induction of labor may lead to increased complications and longer induction of labor times. OBJECTIVE: This study aimed to analyze whether the implementation of an evidence-based standardized care pathway improves the clinical outcomes associated with induction of labor. STUDY DESIGN: This was an approved quality improvement project implementing a clinical care pathway for induction of labor. Moreover, this was a retrospective cohort study of inductions of labor for 5 months before (January 2018 to May 2018) and 14 months after (August 2018 to September 2019) the implementation of the care pathway. The primary outcome was time from admission to delivery. Time from admission to delivery was stratified by mode of delivery. The secondary outcomes included chorioamnionitis, endometritis, neonatal intensive care unit admissions, cesarean delivery, postpartum hemorrhage, and a composite of unanticipated outcomes (chorioamnionitis, endometritis, neonatal intensive care unit admissions, cesarean delivery, and postpartum hemorrhage). In addition, pathway adherence was analyzed. The outcomes were analyzed using 2-tailed t tests for continuous data and the Fisher exact test and chi-square tests for categorical data. Propensity score matching was used to assess for confounding by potential covariates. RESULTS: A total of 1471 inductions of labor were reviewed, with 392 inductions of labor before the implementation of the care pathway and 1079 inductions of labor after the implementation of the care pathway. The pathway was associated with a nonsignificant reduction in the time from admission to delivery by 1.2 hours (from 23.4 to 22.2 hours; P=.08). There was a nonsignificant increase in the time to cesarean delivery before (28.2 hours) and after (28.8 hours) protocol implementation (P=.71). There was a significant decrease in the time to delivery by 1.7 hours for vaginal deliveries (from 22.2 to 20.5 hours) after protocol implementation (P=.02). There was a significant decrease in chorioamnionitis (from 12.5% to 6.0%; odds ratio, 0.44; 95% confidence interval, 0.29-0.67), a significant decrease in endometritis (from 6.9% to 2.6%; odds ratio, 0.36; 95% confidence interval, 0.20-0.65), and a significant decrease in composite unanticipated outcomes (from 56.9% to 36.6%; odds ratio, 0.46; 95% confidence interval, 0.34-0.56) after the implementation of the care pathway. There was no significant difference in postpartum hemorrhage (from 7.9% to 6.1%; odds ratio, 0.76; 95% confidence interval, 0.48-1.22), neonatal intensive care unit admissions (from 18.1% to 14.0%; odds ratio, 0.74; 95% confidence interval, 0.54-1.02), or cesarean deliveries (from 19.6% to 20.1%; odds ratio, 1.03; 95% confidence interval, 0.76-1.40) after the implementation of the care pathway. Pathway adherence varied, ranging from 50% to 89%. CONCLUSION: The introduction of a standardized induction of labor pathway was associated with a nonsignificant reduction in the time from admission to delivery by 1.2 hours and improved pregnancy outcomes, including decreased infections and unanticipated outcomes. Further opportunities for improvements in clinical outcomes may be realized with increased compliance with the care pathway.