Comparison of infants receiving positive-pressure ventilation without tracheotomy vs those with tracheotomy in the first 120 days of life.
Individual patient trends are depicted in addition to overall trend (heavy lines) generated from the mixed-effects model. Thin gray lines correspond to infants who did not undergo tracheotomy; thin green lines correspond to infants who underwent tracheotomy.
Proportion of infants who received tracheotomy based on recorded mean airway pressure at 90 days.
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Wai KC, Keller RL, Lusk LA, Ballard RA, Chan DK, for the Trial of Late Surfactant (TOLSURF) Study Group. Characteristics of Extremely Low Gestational Age Newborns Undergoing Tracheotomy: A Secondary Analysis of the Trial of Late Surfactant Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017;143(1):13–19. doi:https://doi.org/10.1001/jamaoto.2016.2428
What are the clinical indicators for tracheotomy in extremely low gestational age newborns?
In this secondary analysis of a randomized clinical trial of 511 high-risk infants, 15 infants underwent tracheotomy; the mean age at tracheotomy was 126 days. Mean airway pressure declined in the no tracheotomy group, whereas it increased in the tracheotomy group, with the divergence occurring several weeks before the infants underwent tracheotomy.
In high-risk, extremely low gestational age newborns, mean airway pressure trends may help to guide clinical decisions regarding timing of airway evaluation and tracheotomy, which may have neurodevelopmental implications.
Tracheotomy is sometimes performed in extremely low gestational age newborns requiring prolonged ventilation. Studies suggest better neurodevelopmental outcomes in preterm newborns undergoing earlier tracheotomy (<120 days); however, guidelines for who should undergo tracheotomy and when to perform tracheotomy are unclear regarding infants receiving long-term positive-pressure support.
To determine the characteristics associated with tracheotomy in high-risk, extremely low gestational age newborns.
Design, Setting, and Participants
This secondary analysis of infants enrolled in the double-blind, randomized clinical trial known as the Trial of Late Surfactant (TOLSURF) was conducted from January 10, 2010, to September 3, 2013, in neonatal intensive care units. Participants included 511 premature infants (≤28 weeks’ gestational age) who were intubated and mechanically ventilated anytime between 7 and 14 days of life. Infants were randomized to receive late surfactant plus inhaled nitric oxide or inhaled nitric oxide alone. All data were collected prospectively. A mixed-effects model, with patient-level random effects included to account for individual homogeneity, was used to compare mean airway pressure (MAP) during the first 120 days in infants who did not undergo tracheotomy vs those who underwent tracheotomy. The present analysis was conducted from July 1, 2015, to March 29, 2016.
Mean airway pressure, comorbidities of prematurity, airway stenosis, and airway malacia.
Main Outcomes and Measures
Of the 511 infants enrolled in TOLSURF, the mean (SD) gestational age was 25 (1.2) weeks, with a birth weight of 701 (165) g. Fifteen infants (2.9%) underwent tracheotomy. Among those undergoing tracheotomy, 7 infants (46.7%) had airway stenosis or malacia, none of whom died. Of the 8 infants who underwent tracheotomy without airway stenosis or malacia, 4 (50%) died. Mean age at tracheotomy was 126 days (95% CI, 108-144 days). In general, MAP increased over time in the group undergoing tracheotomy (+0.09 cm H2O/wk; 95% CI, 0.06-0.11 cm H2O/wk) but decreased in those who did not undergo tracheotomy (−0.20 cm H2O/wk; 95% CI, 0.19-0.21 cm H2O/wk; P < .001 for interaction).
Conclusions and Relevance
In this cohort of high-risk, extremely low gestational age newborns, trends in MAP can be a clinical indicator for infants requiring long-term positive-pressure ventilation who are at highest risk for receiving tracheotomy. Knowledge of this information may identify infants who would benefit from earlier consideration for tracheotomy.
clinicaltrials.gov Identifier: NCT01022580
Despite increased use of gentler ventilation strategies and improvements in neonatal care, tracheotomy is sometimes performed in extremely low gestational age newborns (ELGANs) requiring prolonged ventilation.1-3 Although the prevalence of tracheotomy ranges from 0.55% to 2.7%, the decision to perform tracheotomy is difficult since these infants often live with significant comorbidities, experience substantial complication rates, and have an increased risk of mortality.4-8 This decision is further complicated by the fact that there is no currently accepted standard for when to evaluate the need for or perform a tracheotomy.9-11
Most studies10,12,13 have focused on indications and acute and long-term outcomes of tracheotomy. Although some studies have identified neonatal risk factors, many are limited by retrospectively collected data, single-institution data, or a broad spectrum of pediatric ages. Very few trials have addressed what factors may be helpful to determine the timing of tracheotomy, especially among ELGANs. A recent study14 showed that, among premature infants who had a tracheostomy, those who had undergone surgery before 120 days of life had improved neurodevelopmental outcomes compared with those who underwent tracheotomy after 120 days. This finding suggests that the timing of tracheotomy is important and should be evaluated further.15
The objective of our study was to determine the characteristics of high-risk ELGANs who undergo tracheotomy. This cohort underwent rigorous prospective data collection as part of a randomized clinical trial. We also evaluated the natural course of respiratory support requirements to determine whether respiratory support trends could help with earlier identification of infants who would undergo tracheotomy.
The present study was a secondary analysis of infants enrolled in the randomized clinical trial known as the Trial of Late Surfactant (TOLSURF), which was conducted from January 10, 2010, to September 3, 2013. All data for this analysis were obtained from the TOLSURF database. TOLSURF has been described in detail.16 In brief, infants who were 28 weeks’ gestational age or less, intubated, and mechanically ventilated anytime between 7 and 14 days of life were included. Infants with major anomalies, active comorbidities, or life expectancy of less than 7 days at the time of screening were excluded from TOLSURF. Overall, 511 infants were randomized to receive late surfactant and inhaled nitric oxide or inhaled nitric oxide alone. There was no difference in the primary outcome in TOLSURF, defined as survival without bronchopulmonary dysplasia at 36 weeks’ postmenstrual age, between the treatment and control groups (relative benefit, 0.98; P = .89).16 The present study was conducted under the initial institutional review board approval. This secondary analysis was conducted on deidentified data and certified to not be considered human subjects research per University of California–San Francisco institutional review board policy. Written informed consent had been provided for the TOLSURF study.
Per TOLSURF protocol, all respiratory support factors were measured 3 times per day up to clinical trial day 45 and recorded once daily thereafter until death or discharge. Mean airway pressure (MAP) was measured for all infants receiving positive-pressure support. Positive-pressure support included both invasive and noninvasive methods and was defined as continuous positive airway pressure using a mask covering only the nose or a mask covering both the nose and mouth, noninvasive mechanical ventilation, conventional mechanical ventilation, or high-frequency oscillator ventilation. Comorbidities were documented throughout hospitalization and were included in this analysis only if they occurred before tracheotomy was performed. Neonatal clinical data were collected prospectively into the study database maintained by the TOLSURF data coordinating center. The primary outcome of the present analysis was tracheotomy.
We compared daily MAP up to 120 days of age in infants undergoing tracheotomy with those requiring positive pressure who did not undergo tracheotomy. The positive-pressure group included infants who were receiving positive-pressure support on a particular day; thus, an infant would be excluded while receiving nasal cannula support but would contribute MAP data later if positive-pressure support was restarted. We chose this age because there may be neurodevelopmental benefits in infants who receive tracheotomy before 120 days of life.14
We then generated a mixed-effects model, with patient-level random effects analyzed to account for repeated measurements within an individual to evaluate MAP during the first 120 days of life among infants who did not undergo tracheotomy vs those who did undergo the procedure. Once an infant underwent tracheotomy, the MAP data beyond the day of surgery no longer contributed to the model. Owing to the small number of outcomes, covariates known to be important for respiratory morbidity in preterm infants or known to be associated with tracheotomy were checked for adjustment in the model. We examined the effects of the following important, independent risk factors for potential inclusion in the model: gestational age, sex, birth weight, maternal race, antenatal corticosteroids, pulmonary hypertension, airway stenosis, airway malacia, and the total number of reintubations. In addition, we analyzed respiratory support requirements at 90 days of life; infants who had already undergone tracheotomy were not considered for this analysis. We chose this age because most infants had reached term, an age when infants have more mature ventilatory control. Thus, we could describe how ventilatory requirements relate to the risk of receiving a tracheotomy after these premature infants were able to develop neurorespiratory control and chest wall stability.17,18
A t test and Fisher exact test were used when appropriate. A 2-tailed α value at P < .05 was considered significant. Statistical analysis was performed using Stata, version 14.0 (StataCorp). The present analysis was conducted from July 1, 2015, to March 29, 2016.
Of 511 infants enrolled in TOLSURF, 15 infants (2.9%) underwent tracheotomy across 12 different sites. The mean age at tracheotomy was 126 days (95% CI, 108-144 days), which corresponds to a mean postmenstrual age of 43 weeks (95% CI, 41-46 weeks). Among those undergoing tracheotomy, 4 infants (26.7%) died before discharge; at discharge, 6 infants (40%) required mechanical ventilation at home, 3 infants (20%) were discharged to home with supplemental oxygen, 1 infant (6.7%) was on room air, and 1 infant’s (6.7%) status was unknown after discharge to an outside hospital; at that time, the infant was still receiving mechanical ventilation. Overall, the mean (SD) gestational age was 25 (1.2) weeks, with a birth weight of 701 (165) g (Table 1). There was no significant difference in gestational age, birth weight, or sex between the tracheotomy and no tracheotomy groups.
The presence of pulmonary hypertension was significantly higher in the tracheotomy group compared with the no tracheotomy group (53.3% vs 14.5%; absolute difference, 38.8%; 95% CI, 13.4% to 64.2%). Infants with airway abnormalities, specifically airway stenosis or malacia, were also more likely to have a tracheostomy (26.7% vs 1%; absolute difference, 25.7%; 95% CI, 3.3% to 48.1%; and 20% vs 1.4%; absolute difference, 18.6%; 95% CI, −1.6% to 38.9%, respectively). No infant in the tracheotomy group with airway stenosis or malacia died. However, 4 of 8 infants (50%) who underwent tracheotomy without airway stenosis or malacia died. Of these 4 infants, 2 died because of pulmonary hypertension and 2 from respiratory disease or bronchopulmonary dysplasia; none of the deaths was due to tracheotomy-related causes.
Despite the low prevalence of tracheostomy in this cohort, there were substantial ventilatory requirements throughout hospitalization for the entire cohort (Table 2). Among all infants, the mean number of days of mechanical ventilation was 44 (95% CI, 41-47 days), with approximately 2 total weeks of high-frequency oscillator ventilation; however, infants in the tracheotomy group had significantly longer periods of respiratory support and more reintubations. Overall, 140 infants (27.4%) did not require reintubation. However, 34 infants (6.7%) were never successfully extubated, and most infants were reintubated either 1 or 2 times (270 [52.8%]) or at least 3 times (67 [13.1%]). Prior to the surgery, infants in the tracheotomy group had a mean of 102 days (95% CI, 85-118 days) of mechanical ventilation and 114 days (95% CI, 96-132 days) of positive-pressure respiratory support.
In general, infants who underwent tracheotomy had higher MAP requirements, even when compared with the subset of infants with prolonged positive-pressure respiratory support who did not undergo tracheotomy (Figure 1). Daily assessment shows that the mean MAP diverged several weeks before 120 days. After using the mixed-effects model, we found that the MAP increased over time in the tracheotomy group but declined in the no tracheotomy group (interaction coefficient, 0.05; 95% CI, 0.03-0.07; P < .00) (Figure 2). None of the covariates proved to have an independent effect above the main exposure variable and thus were excluded from the model. Among infants in the tracheotomy group, MAP increased at a rate of 0.09 cm H2O/wk (95% CI, 0.06-0.11 cm H2O/wk) over the first 120 days. However, for infants in the no tracheotomy group, MAP declined at a rate of 0.20 cm H2O/wk (95% CI, 0.19-0.21 cm H2O/wk).
Although the mean age at tracheotomy was 126 days, differences in MAP were seen earlier. At 90 days of life, the mean postmenstrual age of the entire cohort was 38.1 weeks (95% CI, 38.0-38.2 weeks). Among infants in the tracheotomy group, 1 underwent tracheotomy before 90 days and 2 were not receiving positive-pressure support at 90 days and therefore had no recorded MAP. Infants who underwent tracheotomy after 90 days (n = 12) had significantly higher MAP recordings compared with those who did not (n = 41) (12.1 cm H2O; 95% CI, 9.4-14 cm H2O vs 7.7 cm H2O; 95% CI, 6.8-8.6 cm H2O; absolute difference, 4.4 cm H2O; 95% CI, 2.3-6.5 cm H2O). Of 53 infants still requiring positive-pressure support at 90 days, 12 (22.6%) received a tracheotomy (Figure 3). This incidence increased to 56.3% (9 of 16) for those with a recorded MAP greater than 10 cm H2O and 71.4% (5 of 7) for those with a MAP greater than 14 cm H2O.
In this multicenter secondary analysis of a randomized clinical trial with prospectively collected data on select, high-risk ELGANs, we determined neonatal risk factors for tracheotomy and, to our knowledge, are the first to report and compare the progression of respiratory support in infants who do or do not ultimately undergo tracheotomy.
In our cohort, the daily point estimates of MAP and the mixed-effects model both suggest that infants in the tracheotomy group may be differentiated earlier in their neonatal course. The mixed-effects model accounts for day-to-day variation within an individual, which allows for determination of an infant’s trend in MAP; in contrast, the point estimates measure MAP on a particular day, without respect to an individual’s prior data. Furthermore, the mixed-effects model analyzes every patient, whereas the point estimate analysis is able to analyze only infants receiving positive-pressure support on a particular day. These differences are seen most clearly during the later days of hospitalization. This finding is likely because the data are enriched for sicker individuals; for this group, infants who continue to receive positive pressure may appear to be more similar to infants who ultimately undergo tracheotomy when only point estimates are evaluated. The differences in these analyses do not change the importance of the results. We found that infants who ultimately undergo tracheotomy have increasing respiratory support needs over time, while those who do not undergo tracheotomy have decreasing needs. In addition, we showed that differences in these 2 groups could be seen several weeks before infants underwent tracheotomy.
The decision to perform tracheotomy in infants with prolonged ventilation remains unclear and challenging. Clinical indicators that identify which infants could benefit from tracheotomy and when to perform the surgery are needed to help guide this decision, especially since there may be improved neurodevelopmental outcomes with earlier tracheotomy. DeMauro and colleagues14 hypothesized that this improvement may be due to decreased sedation and an increased opportunity for parent-child interaction and focus on developmental enrichment. Previous studies3,7,19 have focused almost exclusively on primary reasons for tracheotomy, complications, and long-term outcomes. Although guidelines for tracheotomy exist for specific diagnoses, such as craniofacial abnormalities or neurologic impairment, none exist for infants receiving long-term positive-pressure ventilation despite this ventilation being the most common reason for tracheotomy among preterm infants.2,3,19-21 Few studies have sought to address this gap. Among infants weighing less than 1000 g, a case-control study12 including 27 patients found that, on unadjusted analysis, the total number of intubations was associated with tracheotomy, which we also demonstrated in our study. A different study22 also showed a positive association between the number of ventilation courses and tracheotomy, but this association was no longer observed after adjustment for other variables. Although these trials sought to identify risk factors for tracheotomy, they were limited by retrospective design. In contrast, our study analyzed longitudinal data of ventilator support that were collected prospectively. We showed that differences in MAP over time between the tracheotomy and no tracheotomy groups diverged well before tracheotomy was performed based on current clinical practice. Thus, unlike the total number of reintubations, which can be ascertained only at the end of hospitalization and could be related to other factors (eg, sepsis or surgery), an infant’s trend in MAP, a variable more reflective of lung disease compared with intubation alone, may help to guide clinical decision making if infants are unable to be weaned off positive-pressure support.
Using MAP data over time may provide information about which infants are at high risk and when they should be evaluated for tracheotomy. This determination is important since these infants could have undiagnosed, underlying airway abnormalities and could benefit from intervention. A previous study21 showed that, in very low-birth-weight infants with bronchopulmonary dysplasia, 17 of 18 infants (94.4%) who underwent tracheotomy had an upper airway abnormality when evaluated by direct laryngoscopy with bronchoscopy. Our study had a lower prevalence, with 7 of 15 infants (46.7%) having airway abnormalities. None of these 7 infants died, which suggests that those found to have underlying airway disease could derive the most benefit from earlier evaluation and placement of tracheostomy.
We acknowledge limitations to our study. Despite the large number of infants, only 15 had the outcome of interest, and data for individual decisions regarding tracheotomy were not collected. This limited number can make it difficult to draw definitive conclusions of clinical management for all infants who may undergo tracheotomy. However, these numbers reflect the reality of tracheostomy prevalence among preterm infants, with other studies reporting similar numbers. In addition, formal assessment of airway abnormalities and pulmonary hypertension was not performed in all infants. Thus, although we found an apparent association between airway malacia or stenosis and tracheotomy, many infants who were reported as not having these diagnoses were not likely to be assessed by direct laryngoscopy with bronchoscopy for confirmation. Similarly, not all infants received an echocardiogram or underwent cardiac catheterization, which is the standard for diagnosis of pulmonary hypertension. Thus, although airway stenosis or malacia and pulmonary hypertension were risk factors for tracheotomy in our cohort, this increased risk of ultimately undergoing tracheotomy may be biased since only infants with clinical suspicion for these conditions likely received additional evaluation. Finally, our cohort was composed of a select group of high-risk ELGANs from tertiary care neonatal intensive care units. Therefore, our results may not be generalizable to broader populations. Despite these limitations, we were able to compare infants undergoing tracheotomy with an internally valid control group, and our findings are consistent with those of prior studies that have reported similar rates of tracheotomy and increased risk among infants with a diagnosis of pulmonary hypertension. Furthermore, the use of longitudinal data allows us to recognize important implications about the difficult decision of who and when an infant could be reasonably evaluated for tracheotomy.
We found that, even in this high-risk cohort of ELGANs, the prevalence of tracheostomy remains low. Trends in MAP, as well as absolute MAP levels at 90 days of age, could differentiate between infants who eventually underwent tracheotomy compared with those who did not 1 month before these infants received a tracheotomy. These findings suggest that MAP trends and levels can be used to help guide clinical decisions regarding the timing of airway evaluation and tracheotomy, which may have neurodevelopmental implications.14 However, although there is potential benefit, the decision to perform tracheotomy must be balanced with the high morbidity and possible mortality of tracheotomy. Therefore, additional prospective studies are required to develop firmer guidelines for airway evaluation and tracheotomy in infants receiving prolonged positive-pressure ventilation.
Accepted for Publication: July 3, 2016.
Corresponding Author: Dylan K. Chan, MD, PhD, Department of Otolaryngology–Head and Neck Surgery, University of California, 550 16th St, PO Box 3213, San Francisco, CA 94158 (firstname.lastname@example.org).
Published Online: September 1, 2016. doi:10.1001/jamaoto.2016.2428
Author Contributions: Ms Wai and Dr Chan had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Wai, Lusk, Ballard, Chan.
Acquisition, analysis, or interpretation of data: Wai, Keller, Ballard, Chan.
Drafting of the manuscript: Wai, Chan.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Wai, Keller, Lusk, Chan.
Obtaining funding: Wai, Keller, Ballard.
Administrative, technical, or material support: Ballard, Chan.
Study supervision: Keller, Ballard, Chan.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.
Funding/Support: TOLSURF was funded by grants U01-HL094338 and U01-HL094355 from the National Heart, Lung, and Blood Institute (NHLBI). Ms Wai was supported by the National Center for Advancing Translational Sciences, National Institutes of Health, through University of California–San Francisco (UCSF)–Clinical and Translational Science Institute grant UL1 TR000004. ONY, Inc, provided Infasurf, and IKARIA, Inc, provided inhaled nitric oxide and its delivery system for the conduct of the study.
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
The members of the TOLSURF Study Group include:UCSF Benioff Children’s Hospital San Francisco and UCSF Epidemiology and Biostatistics: Philip Ballard, MD, PhD, Elizabeth Rogers, MD, Dennis Black, PhD, Suzanne Hamilton Strong, RN, Jill Immamura-Ching, RN, Margaret Orfanos-Villalobos, RN, Cassandra Williams, RN, Lisa Palermo, MS. Alta Bates Summit Medical Center, Berkeley, California, and UCSF Benioff Children’s Hospital Oakland, Oakland: David Durand, MD, Dolia Horton, RRT, Jeffrey Merrill, MD, Jeanette Asselin, MS, RRT-NPS, Loretta Pacello, RCP, April Willard, RN. University of California Davis Children’s Hospital, Sacramento: Robin Steinhorn, MD. Children’s Mercy Hospital, Kansas City, Missouri: William Truog, MD, Cheryl Gauldin, RN, Anne Holmes, RN, Patrice Johnson, RRT, Kerrie Meinert, RRT. Women and Children’s Hospital of Buffalo, Buffalo, New York: Anne Marie Reynolds, MD, Janine Lucie, NNP, Patrick Conway, MA, Michael Sacilowski, MS, Michael Leadersdorff, RRT, Pam Orbank, RRT, Karen Wynn, NNP. Anne and Robert H. Lurie Children’s Hospital/Northwestern University, Chicago, Illinois: Maria deUngria, MD, Nicolas Porta, MD, Janine Yasmin Khan, MD, Karin Hamann, RN, Molly Schau, RN, Brad Hopkins, RRT, James Jenson, RRT. Texas Children’s Hospital, Houston: Carmen Garcia, RN. Stony Brook University Hospital, Stony Brook, New York: Aruna Parekh, MD, Jila Shariff, MD, Rose McGovern, RN, Jeff Adelman, RRT, Adrienne Combs, RN, Mary Tjersland, RRT. University of Washington, Seattle: Dennis Mayock, MD, Elizabeth Howland, BA, Susan Walker, RN, Jim Longoria, RRT, Holly Meo, RRT. University of Texas Health Science Center, Houston: Eric Eichenwald, MD, Amir Khan, MD, Georgia McDavid, RN, Katrina Burson, RN, BSN, Richard Hinojosa, BSRT, RRT, Christopher Johnson, MBA, RRT, Karen Martin, RN, BSN, Sarah Martin, RN, BSN, Shawna Rogers, RN, BSN, Sharon Wright, MT. University of Florida College of Medicine, Jacksonville, University of Florida Health Shands Hospital, and Wolfson Children’s Hospital, Jacksonville, Florida: Mark Hudak, MD, Kimberly Barnette, RRT, Amanda Kellum, RRT, Michelle Burcke, RN, Christie Hayes, RRT, Stephanie Chadwick, RN, Danielle Howard, RN, Carla Kennedy, RRT, Renee Prince, RN. Wake Forest School of Medicine and Forsyth Medical Center, Winston-Salem, North Carolina: T. Michael O’Shea, MD, Beatrice Stefanescu, MD, Jennifer Helderman, MD, Kelly Warden, RN, Patty Brown, RN, Jennifer Griffin, RRT, Laura Conley, RRT. University of Minnesota Amplatz Children’s Hospital, Minneapolis: Catherine Bendel, MD, Michael Georgieff, MD, Bridget Davern, Marla Mills, RN, Sharon Ritter, RRT. Medical University of South Carolina, Charleston: Carol Wagner, MD, Deanna Fanning, RN, Jimmy Roberson, RRT. Children’s Hospitals and Clinics of Minnesota, St. Paul: Andrea Lampland, MD, Mark Mammel, MD, Pat Meyers, RRT, Angela Brey, RRT, Children’s Hospitals and Clinics of Minnesota, Minneapolis: Ellen Bendel-Stenzel, MD, Neil Mulrooney MD, Cathy Worwa, RRT, Pam Dixon, RN, ANM, Gerald Ebert, RRT-NPS, Cathy Hejl, RRT, Molly Maxwell, RT, Kristin McCullough, RN. University of Tennessee Health Science Center, Memphis: Mohammed T. El Abiad, MD, Ramasubbareddy Dhanireddy, MD, Ajay Talati, MD, Sheila Dempsey, RN, Kathy Gammage, RRT, MBA, Gayle Gower, RN, Kathy James, RRT, Pam LeNoue, RN. All Children’s Hospital, St. Petersburg, Florida: Victor McKay, MD, Suzi Bell, DNP, Dawn Bruton, RN, BSN, CCRP, Michelle Beaulieu, DNP, Richard Williams, RRT. Florida Hospital for Children, Orlando: Rajan Wadhawan, MD, Robin Barron-Nelson, RN, Shane Taylor, RRT. Arkansas Children’s Hospital and University of Arkansas Medical Sciences, Little Rock: Sherry Courtney, MD, Carol Sikes, RN, Gary Lowe, RRT, Betty Proffitt, RRT. University of South Carolina, Charleston: Frances Koch, MD, Rita Ryan, MD. Clinical Coordinating Center: UCSF, Department of Pediatrics: Cheryl Chapin, BA, Hart Horneman, BA, Karin Hamann, RN, Susan Kelley, RRT, Karin Knowles, BA, Nancy Newton, RN, MS, CCRP. Data Coordinating Center: UCSF, Department of Epidemiology and Biostatistics: Eric Vittinghoff, PhD, Jean Hietpas, LCSW, Laurie Denton, BA, Lucy Wu, BA. Data Safety Monitoring Board: Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio: Allan Jobe, MD (chair, 2009-2010). University Hospitals Rainbow Babies and Children’s Hospital, Cleveland, Ohio: Avroy Fanaroff, MD (chair 2010-2016). EMMES Corporation, Rockville, Maryland: Traci Clemons. PhD. Boston University School of Public Health, Boston, Massachusetts: Leonard Glantz, JD. Wake Forest School of Medicine, Winston-Salem, North Carolina: David Reboussin, PhD. Stanford University, Stanford, California: Krisa Van Meurs, MD (2009-2010). The Johns Hopkins University, Baltimore, Maryland: Marilee Allen, MD (2010-2016). Women and Infants Hospital, Providence, Rhode Island: Betty Vohr, MD. Clinical Steering Committee: Department of Pediatrics, UCSF Benioff Children’s Hospital San Francisco, San Francisco: Roberta Ballard, MD, Philip Ballard, MD, PhD, Roberta Keller, MD, Elizabeth Rogers, MD, Nancy Newton, MS, RN, CCRP. UCSF Department of Epidemiology and Biostatistics, San Francisco: Dennis Black, PhD. NHLBI: Carol Blaisdell, MD. UCSF Benioff Children’s Hospital Oakland, Oakland: David Durand, MD, Jeffrey Merrill, MD, Jeanette Asselin, MS, RRT. University of Texas Health Science Center, Houston: Eric Eichenwald, MD. Children’s Hospital and Clinics of Minnesota, St. Paul: Mark Mammel, MD. Medical University of South Carolina, Charleston: Rita Ryan, MD. Children’s Mercy Hospital, Kansas City, Missouri: William Truog, MD.
Previous Presentation: This work was presented as a podium presentation at the American Society of Pediatric Otolaryngology; May 20, 2016; Chicago, Illinois.
Additional Contributions: Nancy Newton, MS, RN, CCRP, served as the project director for the first 4 years of the trial; Karin L. Knowles managed the administrative and regulatory aspects of the study; and Carol Blaisdell, MD, the NHLBI project scientist, served as clinical and scientific liaison to the clinical trial study. We thank the neonatal nurses, nurse practitioners, residents, fellows, and respiratory therapists who made this study possible, as well as the families and infants who participated in the study.
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