Elizabeth E. Foglia

Factors Associated with Adverse Events during Tracheal Intubation in the NICU

Background: The incidence of adverse tracheal intubation-associated events (TIAEs) and associated patient, practice, and intubator characteristics in the neonatal intensive care unit (NICU) setting are unknown. Objectives: To determine the incidence of adverse TIAEs and to identify factors associated with TIAEs in the NICU. Methods: Single-site prospective observational cohort study of infants who were intubated in a level 4 referral NICU between September 1, 2011 and November 30, 2013. A standardized pediatric airway registry was implemented to document patient, practice, and intubator characteristics and outcomes of intubation encounters. The primary outcome was adverse TIAEs. Results: Adverse TIAEs occurred in 153 of 701 (22%) tracheal intubation encounters. Factors that were independently associated with lower incidence of TIAEs in logistic regression included attending physician (vs. resident; odds ratio (OR) 0.4, 95% CI: 0.16, 0.98) and use of paralytic medication (OR 0.45, 95% CI: 0.25, 0.81). Severe oxygen desaturations (≥20% decrease in oxygen saturation) occurred in 51.1% of encounters and were more common in tracheal intubations performed by residents (62.8%), compared to fellows (43.2%) or attendings (47.5%; p = 0.008). Conclusions: Adverse TIAEs and severe oxygen desaturation events are common in the NICU setting. Modifiable risk factors associated with TIAEs identified include intubator training level and use of paralytic medications.

Clinical Predictors of Urinary Tract Infection in the Neonatal Intensive Care Unit

OBJECTIVE To identify clinical predictors associated with urinary tract infections (UTI) in patients in a referral neonatal intensive care unit (NICU). STUDY DESIGN We performed a nested case control study of all NICU patients with urine cultures obtained as part of late-onset sepsis evaluations from January 1, 2007 through December 31, 2007 (N=266). Clinical factors and laboratory results were compared between subjects with positive urine cultures (cases, N= 27) and randomly selected subjects with negative cultures (controls, N= 54). RESULTS Cases were significantly older than controls at the time of urine culture (75 days vs. 29 days, p=0.003). Maximal peripheral white blood cell (WBC) count and C-reactive protein (CRP) did not differ between cases and controls. Only 24% of cases had a simultaneously positive blood culture. In multivariable analysis, only increased chronological age was statistically associated with a positive culture (OR 3.02, 95% CI 1.09, 8.39). CONCLUSION Limited clinical factors exist to identify NICU patients at increased risk for UTI. Peripheral WBC count and CRP do not help discriminate between patients with and without UTI. Clinicians should evaluate chronologically older NICU patients for infection like other young infants, including a urine culture, to adequately identify potential sources of infection.

Carbon dioxide washout during high flow nasal cannula versus nasal CPAP support: An in vitro study

Objective: To compare CO2 washout time at different levels of HFNC versus NCPAP in a premature infant lung model with simulated mouth‐closed and mouth‐open conditions using two sizes of nasal cannula and full‐ and half‐prong HFNC insertion depths. Design/Methods: A piston‐cylinder lung simulator, having a fixed volume of 30 ml and a 4.8 ml dead space, simulated spontaneous breathing (6.5 ml tidal volume, 50 br/min, Ti = 0.5 sec). Two Fisher & Paykel™ cannulas (Fisher & Paykel Healthcare Ltd., Auckland, New Zealand) (2.8 and 3.2 mm O.D.) and two Infant‐Flow™ (CareFusion, Yorba Linda, CA) NCPAP cannulas (3.4 and 4.1 mm O.D.) were applied to simulated airways having either 3.5 or 4.5 mm I.D. nares. Simulated mouth opening was a 5 mm I.D. side tap below the nasal interface. The lung was primed with 5% CO2. Washout times were determined at HFNC settings of 3, 4, 5, 6, and 8 L/min and NCPAP at 3, 4, 5, 6, and 8 cm H2O with simulated open and closed‐mouth conditions and full‐ and half‐inserted HFNC prongs. Results: Overall combined mean washout times for NCPAP with mouth‐closed were significantly longer than HFNC over all five pressure and flow device settings by 16.2% (P < 0.001). CO2 washout times decreased as flow or pressure device settings were increased. There were negligible differences in washout times between NCPAP and HFNC with mouth‐open. Mouth‐open washout times were significantly less than mouth‐closed for all conditions. Overall closed‐mouth washout times for HFNC half‐prong insertion were longer than for full‐prong insertion by 5.3% (P < 0.022). Conclusions: Significantly improved CO2 elimination using HFNC versus NCPAP should be a particularly important consideration in premature infants having very high dead space‐to‐tidal volume ratio compared to larger infants. Pediatr Pulmonol. 2017;52:792–798.

Short-term Outcomes of Infants Enrolled in Randomized Clinical Trials vs Those Eligible but Not Enrolled

It is unknown whether participation in a neonatal randomized controlled trial (RCT) is independently associated with differences in outcomes. Our objective was to compare inhospital outcomes between extremely premature infants enrolled in RCTs and those who were eligible but not enrolled in RCTs conducted by the National Institute of Child Health and Human Development Neonatal Research Network (NRN).

The Emerging Market of Smartphone-Integrated Infant Physiologic Monitors

In the past 2 years, a new class of infant physiologic monitors marketed to parents for use in the home has emerged. Smartphone applications (apps) integrated with sensors built into socks, onesies, buttons, leg bands, and diaper clips have the capability to display infants’ respirations, pulse rate, and blood oxygen saturation, and to generate alarms for apnea, tachycardia, bradycardia, and desaturation (Table). Despite the lack of publicly available evidence supporting the safety, accuracy, effectiveness, or role of these monitors in the care of well infants, sales of these products are brisk and the market is expanding. For example, the makers of a “smart sock” monitor (Owlet Baby Care) that claims to alert parents if their infant stops breathing1 recently reported sales of 40 000 units at

Delivery Room Research: When Does Poor Quality Evidence Become an Ethical Issue?

250 each.2

Improving neonatal intubation safety: A journey of a thousand miles

The November 2014 Ethics Rounds questioned: “When is waiver of consent appropriate in a neonatal clinical trial?” As neonatal clinical trialists, we believe that a waiver of prospective informed consent is often required and ethically appropriate to conduct scientifically rigorous delivery room clinical trials. As Drs Wootton, Arnold, and Tyson acknowledged, many emergency therapies have never been rigorously studied. Neonatal resuscitation medicine is especially bereft of high-level evidence. Only 23 of 157 (15%) publications cited in the 2010 ILCOR statement on neonatal resuscitation were randomized trials or meta-analyses of trials … E-mail: foglia{at}email.chop.edu

When has enough evidence accumulated to change neonatal practice

Neonatal intubation is one of the most common procedures performed by neonatologists, however, the procedure is difficult and high risk. Neonates who endure the procedure often experience adverse events, including bradycardia and severe oxygen desaturations. Because of low first attempt success rates, neonates are often subjected to multiple intubation attempts before the endotracheal tube is successfully placed. These factors conspire to make intubation one of the most dangerous procedures in neonatal medicine. In this commentary we review key elements in the journey to improve neonatal intubation safety. We begin with a review of intubation success rates and complications. Then, we discuss the importance of intubation training. Next, we examine quality improvement efforts and patient safety research to improve neonatal intubation safety. Finally, we evaluate new tools which may improve success rates, and decrease complications during neonatal intubation.

Long-Term Respiratory Morbidity in Preterm Infants: Is Noninvasive Support in the Delivery Room the Solution?

Randomized clinical trials are the best method to assess the safety and efficacy of therapeutic interventions. However, it is not always clear how much evidence from randomized trials is required to change clinical practice. Throughout the history of neonatal medicine, some therapies were subject to excessive and unnecessary testing through replication of clinical trials. Other therapies were adopted into clinical practice with insufficient evidence. In only a few cases was the right amount of evidence accumulated to drive a change in practice. Here we present a case history for each of these three scenarios. Arising from these, we suggest principles to identify when enough evidence exists for a therapy to become standard practice.

Obtaining informed consent for delivery room research: the investigators' perspective

See related articles, p and p tion and stabilization of the extremely preterm infant. Two articles in this issue of The Journal provide insight into how delivery room (DR) practice may be improved and may influence the shortand long-term outcomes of preterm infants. In survivors of prematurity, spirometry at school age consistently demonstrates decreased lung function compared with full-term controls. These deficits are more severe in extremely preterm infants with bronchopulmonary dysplasia (BPD). Worse, such effects persist throughout childhood and likely into adulthood. In addition to the known impact of prematurity on long-term respiratory morbidity, BPD is an independent predictor of neurodevelopmental outcomes at 18 months. Similarly, duration of ventilation beyond 60 days is correlated with developmental impairment at 18 months. Thus, strategies to prevent lung disease of prematurity and its associated long-term sequelae are needed. Although neonatologists have recognized the potential impact ofDR interventions on the outcomes of preterm infants for some time, such interventions have only recently been studied systematically in large randomized trials. Several trials have evaluated the use of continuous positive airway pressure (CPAP) in comparisonwith immediate intubation and surfactant administration. These individual studies show trends toward decreased rates of death or BPD and reduced need for surfactant with the use of noninvasive support, but no significant differences. This is likely due to individual trials being underpowered to identify this treatment effect because three pooled analyses including over 3000 infants demonstrate that strategies aimed at avoiding early mechanical ventilation in preterm infants have a “small but significant beneficial impact” for the prevention death or BPD. Although these analyses differ in significant details, they consistently report a significant reduction of death or BPD in infants treated withCPAP, with a number needed to treat (NNT, 25-35 infants treated with