WHAT'S KNOWN ON THIS SUBJECT: Participating in a trial may affect processes of care by participating physicians; however, no study has assessed whether it affects processes of care for nonenrolled patients.WHAT THIS STUDY ADDS: Participation in a trial may affect processes of care for nonenrolled patients, even when care providers participating in or familiar with the trial protocol are unaware that data on nonenrolled patients are being collected for a study. weeks' gestational age (GA) were randomized in the delivery room (DR) to endotracheal intubation or nasal continuous positive airway pressure. We hypothesized that DR intubation could change in nonenrolled patients at PMH and that the change would be larger than in comparable centers not participating in the trial. METHODS:The PMH Cohort included eligible but nonenrolled neonates of 24 0/7 to 27 6/7 weeks (primary) and noneligible neonates of 28 to 34 6/7 weeks (confirmatory). A subset (24 0/7 -29 6/7 weeks) of that cohort was compared with a contemporaneous cohort born in centers participating in the Vermont Oxford Network (VON). We used a Poisson regression model to obtain adjusted relative risks (RRs) of DR intubation (during/after SUPPORT versus before SUPPORT) for PMH and for VON along with the ratio of these RRs. RESULTS:In the PMH cohort (n = 3527), the proportion of DR intubation decreased during/after SUPPORT in the lower GA group (adjusted RR 0.76, 95% confidence interval [CI] 0.59-0.96) and the upper GA group (adjusted RR 0.57, 95% CI 0.46-0.70). Compared with the RR for DR intubation in VON, the RR at PMH was smaller in the lower (ratio of RR 0.76, 95% CI 0.65-0.87) and the upper GA group (ratio of RR 0.52, 95% CI 0.39-0.68).CONCLUSIONS: A center' s participation in an unblinded randomized trial may affect process of care of nonenrolled patients. Pediatrics 2013;132:e960-e970 AUTHORS:

Objectives To describe the variation of in-neonatal intensive care unit (NICU) cardiopulmonary resuscitation (CPR) characteristics and outcomes across different gestational ages and levels of NICU care. Study Design This is a retrospective cohort study of in-NICU CPR events across 10 NICUs in San Antonio, TX from 2012 through 2017. Results We identified 140 patients experiencing a total of 210 in-NICU CPR events. CPR was performed in 0.23% of Level III and 0.85% of Level IV NICU admissions. Gestational age was inversely related to CPR incidence. The median age at in-NICU CPR was lower for preterm versus term infants (6 vs. 28 days, p = 0.002). With regression modeling, each added minute of chest compression decreased the odds of return to spontaneous circulation by 11%. Conclusion In-NICU CPR incidence rises with decreasing gestational age and increasing level of NICU care. The rate of return of spontaneous circulation decreases significantly with increasing duration of chest compressions. Further study is needed to identify patient factors associated with adverse outcome.

Objective To test the hypothesis that the proportion of endotracheal intubation (ETI) in the delivery room (DR) decreased in Neonatal Research Network (NRN) centres after the National Institute of Child Health and Human Development NRN Surfactant, Positive Pressure, and Oxygenation Randomised Trial (SUPPORT). Design Retrospective cohort study using the prospective NRN generic database. Setting Eleven centres that participated in the SUPPORT trial and remained part of the NRN. Preterm neonates 240/7–276/7 weeks’ gestational age enrolled in the SUPPORT trial were randomised to: (1) DR continuous positive airway pressure or DR ETI with early surfactant administration; and (2) oxygen saturation targets of 85–89% or 91–95%. The prior NRN feasibility trial had assessed the feasibility of randomisation to continuous positive airway pressure versus ETI. Patients Infants 240/7–276/7 weeks’ gestational age, excluding infants with syndromes or major malformations and those on comfort care only. Main outcome measure Proportion of DR ETI. Results The proportion of DR ETI decreased significantly in the group of infants from centres that had not participated in the feasibility trial (91% before vs 75% after SUPPORT, adjusted relative risk 0.86, 95% CI 0.83–0.89, p<0.0001) but not in the group of infants from the other centres, where the proportion of ETI was already lower prior to initiation of the SUPPORT trial (61% before vs 58% after SUPPORT, adjusted relative risk 0.96, 95% CI 0.89 to 1.05, p=0.40). Conclusion This study shows that DR ETI changed after SUPPORT only in NRN centres that had not participated in a similar trial.

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Introduction: Limited data exists regarding cardiopulmonary resuscitation (CPR) in infants in the Neonatal Intensive Care Unit (NICU). Objectives included determining the incidence, demographics, diagnoses, and outcomes of infants who require CPR across 10 NICUs in San Antonio, Texas. Methods: We conducted a retrospective review of in-NICU CPR events requiring chest compressions for 1 minute from 2012 - 2017. Included NICUs provided the following levels of care: two level IV, two high acuity level III, four low acuity level III, and two level II. Case identification occurred by reviewing death summaries and CPR coding in the electronic medical record. Results: In total, 139 infants (81 or 58% male) required 211 episodes of CPR. CPR incidence per 1000 patient days was 0.68, 0.37, 0.02 and 0 among level IV, high acuity level III, low acuity level III, and level II NICUs, respectively. Median birth weight was 945 (IQR 630, 2243) grams, gestational age at birth 27 (IQR 24, 34) weeks and age at CPR 11 (IQR 1, 42) days. Only 27 events (13%) occurred in term infants. Ninety-three CPR events (44%) had a primary respiratory etiology, 38 (18%) circulatory, 36 (17%) infectious, and 24 (11%) metabolic. Term and preterm infants had significantly different CPR etiologies (p=0.036). Circulatory etiologies were more common in term infants (37% vs 15%) with respiratory etiologies being less common (33.3% vs 46.2%). The most common rhythm documented leading to initiation of CPR was bradycardia (63%), followed by asystole (19%), and pulseless electrical activity (14%). The median duration of CPR was 10 (IQR 4, 25.5) minutes and chest compressions 8 (IQR 3, 18) minutes. While 135 of 211 CPR events (64%) had ROSC, only 22 of 139 patients (16%) survived to hospital discharge. The rate of ROSC among Level IV NICUs was significantly higher than in high acuity level III NICUs (68.2% vs 51.9%, p = 0.034). Conclusions: NICU CPR events occur most commonly in premature infants and are respiratory in origin. Bradycardia is the most common initial rhythm requiring CPR in the NICU. The incidence of CPR and the rate of ROSC are higher in level IV than level III NICUs. Further investigation is needed into factors associated with ROSC for in-NICU CPR.