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OBJECTIVE: To identify delivery room (DR) characteristics of patients with transposition of the great arteries (TGA) who underwent preoperative balloon atrial septostomy (BAS). STUDY DESIGN: Retrospective cohort study of all patients with prenatally diagnosed TGA delivered at our center between 2013 and 2023 who underwent arterial switch operation during the newborn admission. RESULTS: A total of 168 patients were included (median gestational age 39.5 weeks, 64% male, 33% with ventricular septal defect [VSD], 8% with aortic arch hypoplasia). BAS was performed in 84 patients (50%). Patients who underwent BAS had higher proportion of intubation in the DR (87% vs. 33%, p<0.001), lower maximum oxygen saturation in the first 10 minutes (64% vs. 74%, p<0.001) and 20 minutes (71% vs. 81%, p<0.001) of life, and lower maximum oxygen saturation at any point in the DR (79% vs. 87%, p<0.001). Adjusting for confounders (VSD, aortic arch anomaly, 5-minute Apgar, birth weight), intubation in the DR (adjusted odds ratio [aOR] 9.5, 95% CI 3.9, 25.0) and lower maximum oxygen saturation in the DR (aOR 0.9, 95% CI 0.8, 0.9) were independently associated with BAS. By receiver operating characteristic analysis, a maximum oxygen saturation of less than 86% at any timepoint in the DR discriminated for BAS with a specificity of 0.88, sensitivity of 0.70, and area under the curve of 0.82. CONCLUSIONS: Intubation and lower oxygen saturation in the DR are independently associated with BAS in patients with TGA born at our center. A maximum DR saturation of less than 86% best discriminates patients who undergo BAS in our population.
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OBJECTIVE: To identify associations between procedural characteristics and success of neonatal tracheal intubation (NTI) using video laryngoscopy (VL). DESIGN: Prospective single-centre observational study. SETTING: Quaternary neonatal intensive care unit. PATIENTS: Infants requiring NTI at the Children's Hospital of Philadelphia. INTERVENTIONS: VL NTI recordings were evaluated to assess 11 observable procedural characteristics hypothesised to be associated with VL NTI success. These characteristics included measures of procedural time and performance, glottic exposure and position, and laryngoscope blade tip location. MAIN OUTCOME MEASURE: VL NTI attempt success. RESULTS: A total of 109 patients underwent 109 intubation encounters with 164 intubation attempts. The first attempt success rate was 65%, and the overall encounter success rate was 100%. Successful VL NTI attempts were associated with shorter procedural duration (36 s vs 60 s, p<0.001) and improved Cormack-Lehane grade (63% grade I vs 49% grade II, p<0.001) compared with unsuccessful NTIs. Other factors more common in successful NTI attempts than unsuccessful attempts were laryngoscope blade placement to lift the epiglottis (45% vs 29%, p=0.002), fewer tracheal tube manoeuvres (3 vs 8, p<0.001) and a left-sided or non-visualised tongue location (76% vs 56%, p=0.009). CONCLUSION: We identified procedural characteristics visible on the VL screen that are associated with NTI procedural success. Study results may improve how VL is used to teach and perform neonatal intubation.
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OBJECTIVE: To identify associations between procedural characteristics and success of neonatal tracheal intubation (NTI) using video laryngoscopy (VL). DESIGN: Prospective single-centre observational study. SETTING: Quaternary neonatal intensive care unit. PATIENTS: Infants requiring NTI at the Children's Hospital of Philadelphia. INTERVENTIONS: VL NTI recordings were evaluated to assess 11 observable procedural characteristics hypothesised to be associated with VL NTI success. These characteristics included measures of procedural time and performance, glottic exposure and position, and laryngoscope blade tip location. MAIN OUTCOME MEASURE: VL NTI attempt success. RESULTS: A total of 109 patients underwent 109 intubation encounters with 164 intubation attempts. The first attempt success rate was 65%, and the overall encounter success rate was 100%. Successful VL NTI attempts were associated with shorter procedural duration (36 s vs 60 s, p<0.001) and improved Cormack-Lehane grade (63% grade I vs 49% grade II, p<0.001) compared with unsuccessful NTIs. Other factors more common in successful NTI attempts than unsuccessful attempts were laryngoscope blade placement to lift the epiglottis (45% vs 29%, p=0.002), fewer tracheal tube manoeuvres (3 vs 8, p<0.001) and a left-sided or non-visualised tongue location (76% vs 56%, p=0.009). CONCLUSION: We identified procedural characteristics visible on the VL screen that are associated with NTI procedural success. Study results may improve how VL is used to teach and perform neonatal intubation.
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Objectives: Characterize short-term outcomes of late preterm and term infants who received positive pressure ventilation in the delivery room and compare these with infants who did not receive resuscitation at birth. Study Design: Single center retrospective cohort study of infants born between 35 0/7 and 41 6/7 weeks' gestation in 2019. Baseline characteristics and outcomes of infants who received positive pressure ventilation were compared with controls who did not receive delivery room ventilation. The primary outcome was neonatal intensive care unit admission; secondary outcomes included multiple hospital morbidities and interventions. Results: Among 202 infants who received delivery room positive pressure ventilation, 77 (38.1%) received ≤1 min, and 125 (61.9%) received >1 min of positive pressure ventilation. Neonatal intensive care unit admission directly following resuscitation was more common in the ventilation cohort (33%) compared with controls (1.5%), p ≤ 0.0001. After initial admission to the newborn nursery, intensive care unit transfer rates were similar in the positive pressure ventilation cohort (4%) and controls (5%). Antibiotic exposure, hypoxic ischemic encephalopathy, respiratory support in the neonatal intensive care unit, and pneumothorax were more common in the ventilation cohort. The composite outcome of any post-delivery complication occurred in 45% of positive pressure ventilation-exposed infants, compared to 15.8% of control infants (<0.0001); this was more common following >1 min (52.8%) than ≤1 min positive pressure ventilation (32.5%), p = 0.002. Conclusion: Post-delivery complications are common following delivery room positive pressure ventilation, emphasizing the need for post-resuscitation monitoring in either the neonatal intensive care unitor newborn nursery setting.
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OBJECTIVE: To determine the association between initial delivery room (DR) ventilator (conventional mechanical ventilation [CMV] versus high frequency oscillatory ventilation [HFOV] and hospital outcomes for infants with severe congenital diaphragmatic hernia (CDH). STUDY DESIGN: Quasi-experimental design before/after introducing a clinical protocol promoting HFOV. The primary outcome was first blood gas parameters. Secondary outcomes included serial blood gas assessments, ECMO, survival, duration of ventilation, and length of hospitalization. RESULTS: First pH and CO2 were more favorable in the HFOV group (n = 75) than CMV group (n = 85), median (interquartile range (IQR)) pH 7.18 (7.03, 7.24) vs. 7.05 (6.93, 7.17), adjusted p-value < 0.001; median CO2 62.0 (46.0, 82.0) vs 85.9 (59.0, 103.0), adjusted p-value < 0.001. ECMO, survival, duration of ventilation, and length of hospitalization did not differ between groups in adjusted analysis. CONCLUSION: Among infants with severe CDH, initial DR HFOV was associated with improved early gas exchange with no adverse differences in hospital outcomes.
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OBJECTIVE: To assess whether initial epinephrine administration by endotracheal tube (ET) in newly born infants receiving chest compressions and epinephrine in the delivery room (DR) is associated with lower rates of return of spontaneous circulation (ROSC) than newborns receiving initial intravenous (IV) epinephrine. STUDY DESIGN: We conducted a retrospective review of neonates receiving chest compressions and epinephrine in the DR from the AHA Get With The Guidelines-Resuscitation registry from October 2013 through July 2020. Neonates were classified according to initial route of epinephrine (ET vs IV). The primary outcome of interest was ROSC in the DR. RESULTS: In total, 408 infants met inclusion criteria; of these, 281 (68.9%) received initial ET epinephrine and 127 (31.1%) received initial IV epinephrine. The initial ET epinephrine group included those infants who also received subsequent IV epinephrine when ET epinephrine failed to achieve ROSC. Comparing initial ET with initial IV epinephrine, ROSC was achieved in 70.1% vs 58.3% (adjusted risk difference 10.02; 95% CI 0.05-19.99). ROSC was achieved in 58.3% with IV epinephrine alone, and 47.0% with ET epinephrine alone, with 40.0% receiving subsequent IV epinephrine. CONCLUSIONS: This study suggests that initial use of ET epinephrine is reasonable during DR resuscitation, as there were greater rates of ROSC compared with initial IV epinephrine administration. However, administration of IV epinephrine should not be delayed in those infants not responding to initial ET epinephrine, as almost one-half of infants who received initial ET epinephrine subsequently received IV epinephrine before achieving ROSC.
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Reanimación Cardiopulmonar , Salas de Parto , Epinefrina , Intubación Intratraqueal , Humanos , Epinefrina/administración & dosificación , Recién Nacido , Estudios Retrospectivos , Reanimación Cardiopulmonar/métodos , Femenino , Masculino , Paro Cardíaco/terapia , Paro Cardíaco/tratamiento farmacológico , Administración Intravenosa , Bases de Datos Factuales , Retorno de la Circulación Espontánea , Sistema de Registros , Vasoconstrictores/administración & dosificaciónRESUMEN
BACKGROUND: Invasive mechanical ventilation contributes to bronchopulmonary dysplasia (BPD), the most common complication of prematurity and the leading respiratory cause of childhood morbidity. Non-invasive ventilation (NIV) may limit invasive ventilation exposure and can be either synchronized or non-synchronized (NS). Pooled data suggest synchronized forms may be superior. Non-invasive neurally adjusted ventilatory assist (NIV-NAVA) delivers NIV synchronized to the neural signal for breathing, which is detected with a specialized catheter. The DIVA (Diaphragmatic Initiated Ventilatory Assist) trial aims to determine in infants born 240/7-276/7 weeks' gestation undergoing extubation whether NIV-NAVA compared to non-synchronized nasal intermittent positive pressure ventilation (NS-NIPPV) reduces the incidence of extubation failure within 5 days of extubation. METHODS: This is a prospective, unblinded, pragmatic, multicenter phase III randomized clinical trial. Inclusion criteria are preterm infants 24-276/7 weeks gestational age who were intubated within the first 7 days of life for at least 12 h and are undergoing extubation in the first 28 postnatal days. All sites will enter an initial run-in phase, where all infants are allocated to NIV-NAVA, and an independent technical committee assesses site performance. Subsequently, all enrolled infants are randomized to NIV-NAVA or NS-NIPPV at extubation. The primary outcome is extubation failure within 5 days of extubation, defined as any of the following: (1) rise in FiO2 at least 20% from pre-extubation for > 2 h, (2) pH ≤ 7.20 or pCO2 ≥ 70 mmHg; (3) > 1 apnea requiring positive pressure ventilation (PPV) or ≥ 6 apneas requiring stimulation within 6 h; (4) emergent intubation for cardiovascular instability or surgery. Our sample size of 478 provides 90% power to detect a 15% absolute reduction in the primary outcome. Enrolled infants will be followed for safety and secondary outcomes through 36 weeks' postmenstrual age, discharge, death, or transfer. DISCUSSION: The DIVA trial is the first large multicenter trial designed to assess the impact of NIV-NAVA on relevant clinical outcomes for preterm infants. The DIVA trial design incorporates input from clinical NAVA experts and includes innovative features, such as a run-in phase, to ensure consistent technical performance across sites. TRIAL REGISTRATION: www. CLINICALTRIALS: gov , trial identifier NCT05446272 , registered July 6, 2022.
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Soporte Ventilatorio Interactivo , Ventilación no Invasiva , Lactante , Recién Nacido , Humanos , Ventilación con Presión Positiva Intermitente/efectos adversos , Recien Nacido Extremadamente Prematuro , Soporte Ventilatorio Interactivo/efectos adversos , Soporte Ventilatorio Interactivo/métodos , Extubación Traqueal/efectos adversos , Estudios Prospectivos , Ventilación no Invasiva/efectos adversos , Ventilación no Invasiva/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto , Ensayos Clínicos Fase III como AsuntoRESUMEN
BACKGROUND AND OBJECTIVES: Neonatal endotracheal tube (ETT) size recommendations are based on limited evidence. We sought to determine data-driven weight-based ETT sizes for infants undergoing tracheal intubation and to compare these with Neonatal Resuscitation Program (NRP) recommendations. METHODS: Retrospective multicenter cohort study from an international airway registry. We evaluated ETT size changes (downsizing to a smaller ETT during the procedure or upsizing to a larger ETT within 7 days) and risk of procedural adverse outcomes associated with first-attempt ETT size selection when stratifying the cohort into 200 g subgroups. RESULTS: Of 7293 intubations assessed, the initial ETT was downsized in 5.0% of encounters and upsized within 7 days in 1.5%. ETT downsizing was most common when NRP-recommended sizes were attempted in the following weight subgroups: 1000 to 1199 g with a 3.0 mm (12.6%) and 2000 to 2199 g with a 3.5 mm (17.1%). For infants in these 2 weight subgroups, selection of ETTs 0.5 mm smaller than NRP recommendations was independently associated with lower odds of adverse outcomes compared with NRP-recommended sizes. Among infants weighing 1000 to 1199 g: any tracheal intubation associated event, 20.8% with 2.5 mm versus 21.9% with 3.0 mm (adjusted OR [aOR] 0.62, 95% confidence interval [CI] 0.41-0.94); severe oxygen desaturation, 35.2% with 2.5 mm vs 52.9% with 3.0 mm (aOR 0.53, 95% CI 0.38-0.75). Among infants weighing 2000 to 2199 g: severe oxygen desaturation, 41% with 3.0 mm versus 56% with 3.5mm (aOR 0.55, 95% CI 0.34-0.89). CONCLUSIONS: For infants weighing 1000 to 1199 g and 2000 to 2199 g, the recommended ETT size was frequently downsized during the procedure, whereas 0.5 mm smaller ETT sizes were associated with fewer adverse events and were rarely upsized.
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Intubación Intratraqueal , Resucitación , Humanos , Recién Nacido , Estudios de Cohortes , Intubación Intratraqueal/métodos , OxígenoRESUMEN
INTRODUCTION: Delivery room (DR) interventions for infants with congenital diaphragmatic hernia (CDH) are not well described. This study sought to describe timing and order of DR interventions and identify system factors impacting CDH DR resuscitations using a human factors framework. METHODS: Single center observational study of video recorded CDH DR resuscitations documenting timing and order of interventions. The team used the Systems Engineering Initiative for Patient Safety (SEIPS) model to identify system factors impacting DR resuscitations and time to invasive ventilation. RESULTS: We analyzed 31 video recorded CDH resuscitations. We observed variability in timing and order of resuscitation tasks. The 'Internal Environment' and 'Tasks' components of the SEIPS model were prominent factors affecting resuscitation efficiency; significant room and bed spatial constraints exist, and nurses have a significant task burden. Additionally, endotracheal tube preparation was a prominent barrier to timely invasive ventilation. CONCLUSION: Video review revealed variation in event timing and order during CDH resuscitations. Standardization of room set-up, equipment, and event order and reallocation of tasks facilitate more efficient intubation and ventilation, representing targets for CDH DR improvement initiatives. This work emphasizes the utility of rigorous human factors review to identify areas for improvement during DR resuscitation.
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Inhaled nitric oxide (iNO) is a pulmonary vasodilator considered standard of care to treat persistent pulmonary hypertension of the newborn. However, not all infants respond to iNO. The authors performed a systematic review to examine methodology, outcomes, and challenges of randomized controlled trials testing pulmonary vasodilator medications adjunctive to iNO. The 5 trials identified showed heterogeneity in eligibility criteria and outcomes assessed. No trial achieved recruitment goals, limiting conclusions regarding efficacy, safety, and pharmacology. Trial design consensus and alternative methodologic strategies such as deferred consent, real-world controls, nonrandomized database assessments, and Bayesian statistical approaches are needed.
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Hipertensión Pulmonar , Óxido Nítrico , Recién Nacido , Humanos , Óxido Nítrico/uso terapéutico , Vasodilatadores/uso terapéutico , Hipertensión Pulmonar/tratamiento farmacológico , Teorema de Bayes , Ensayos Clínicos Controlados Aleatorios como Asunto , Administración por InhalaciónRESUMEN
OBJECTIVE: To determine the factors associated with second attempt success and the risk of adverse events following a failed first attempt at neonatal tracheal intubation. DESIGN: Retrospective analysis of prospectively collected data on intubations performed in the neonatal intensive care unit (NICU) and delivery room from the National Emergency Airway Registry for Neonates (NEAR4NEOS). SETTING: Eighteen academic NICUs in NEAR4NEOS. PATIENTS: Neonates requiring two or more attempts at intubation between October 2014 and December 2021. MAIN OUTCOME MEASURES: The primary outcome was successful intubation on the second attempt, with severe tracheal intubation-associated events (TIAEs) or severe desaturation (≥20% decline in oxygen saturation) being secondary outcomes. Multivariate regression examined the associations between these outcomes and patient characteristics and changes in intubation practice. RESULTS: 5805 of 13 126 (44%) encounters required two or more intubation attempts, with 3156 (54%) successful on the second attempt. Second attempt success was more likely with changes in any of the following: intubator (OR 1.80, 95% CI 1.56 to 2.07), stylet use (OR 1.65, 95% CI 1.36 to 2.01) or endotracheal tube (ETT) size (OR 2.11, 95% CI 1.74 to 2.56). Changes in stylet use were associated with a reduced chance of severe desaturation (OR 0.74, 95% CI 0.61 to 0.90), but changes in intubator, laryngoscope type or ETT size were not; no changes in intubator or equipment were associated with severe TIAEs. CONCLUSIONS: Successful neonatal intubation on a second attempt was more likely with a change in intubator, stylet use or ETT size.
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The International Liaison Committee on Resuscitation engages in a continuous review of new, peer-reviewed, published cardiopulmonary resuscitation and first aid science. Draft Consensus on Science With Treatment Recommendations are posted online throughout the year, and this annual summary provides more concise versions of the final Consensus on Science With Treatment Recommendations from all task forces for the year. Topics addressed by systematic reviews this year include resuscitation of cardiac arrest from drowning, extracorporeal cardiopulmonary resuscitation for adults and children, calcium during cardiac arrest, double sequential defibrillation, neuroprognostication after cardiac arrest for adults and children, maintaining normal temperature after preterm birth, heart rate monitoring methods for diagnostics in neonates, detection of exhaled carbon dioxide in neonates, family presence during resuscitation of adults, and a stepwise approach to resuscitation skills training. Members from 6 International Liaison Committee on Resuscitation task forces have assessed, discussed, and debated the quality of the evidence, using Grading of Recommendations Assessment, Development, and Evaluation criteria, and their statements include consensus treatment recommendations. Insights into the deliberations of the task forces are provided in the Justification and Evidence-to-Decision Framework Highlights sections. In addition, the task forces list priority knowledge gaps for further research. Additional topics are addressed with scoping reviews and evidence updates.
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Reanimación Cardiopulmonar , Servicios Médicos de Urgencia , Paro Cardíaco Extrahospitalario , Nacimiento Prematuro , Adulto , Femenino , Niño , Recién Nacido , Humanos , Primeros Auxilios , Consenso , Paro Cardíaco Extrahospitalario/terapia , Reanimación Cardiopulmonar/métodosRESUMEN
Aim: Neonatal resuscitation guidelines promote the laryngeal mask (LM) interface for positive pressure ventilation (PPV), but little is known about how the LM is used among Neonatal Resuscitation Program (NRP) Providers and Instructors. The study aim was to characterize the training, experience, confidence, and perspectives of NRP Providers and Instructors regarding LM use during neonatal resuscitation at birth. Methods: A voluntary anonymous survey was emailed to all NRP Providers and Instructors. Survey items addressed training, experience, confidence, and barriers for LM use during resuscitation. Associations between respondent characteristics and outcomes of both LM experience and confidence were assessed using logistic regression. Results: Between 11/7/22-12/12/22, there were 5,809 survey respondents: 68% were NRP Providers, 55% were nurses, and 87% worked in a hospital setting. Of these, 12% had ever placed a LM during newborn resuscitation, and 25% felt very or completely confident using a LM. In logistic regression, clinical or simulated hands-on training, NRP Instructor role, professional role, and practice setting were all associated with both LM experience and confidence.The three most frequently identified barriers to LM use were insufficient experience (46%), preference for other interfaces (25%), and failure to consider the LM during resuscitation (21%). One-third (33%) reported that LMs are not available where they resuscitate newborns. Conclusion: Few NRP providers and instructors use the LM during neonatal resuscitation. Strategies to increase LM use include hands-on clinical training, outreach promoting the advantages of the LM compared to other interfaces, and improving availability of the LM in delivery settings.
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The International Liaison Committee on Resuscitation engages in a continuous review of new, peer-reviewed, published cardiopulmonary resuscitation and first aid science. Draft Consensus on Science With Treatment Recommendations are posted online throughout the year, and this annual summary provides more concise versions of the final Consensus on Science With Treatment Recommendations from all task forces for the year. Topics addressed by systematic reviews this year include resuscitation of cardiac arrest from drowning, extracorporeal cardiopulmonary resuscitation for adults and children, calcium during cardiac arrest, double sequential defibrillation, neuroprognostication after cardiac arrest for adults and children, maintaining normal temperature after preterm birth, heart rate monitoring methods for diagnostics in neonates, detection of exhaled carbon dioxide in neonates, family presence during resuscitation of adults, and a stepwise approach to resuscitation skills training. Members from 6 International Liaison Committee on Resuscitation task forces have assessed, discussed, and debated the quality of the evidence, using Grading of Recommendations Assessment, Development, and Evaluation criteria, and their statements include consensus treatment recommendations. Insights into the deliberations of the task forces are provided in the Justification and Evidence-to-Decision Framework Highlights sections. In addition, the task forces list priority knowledge gaps for further research. Additional topics are addressed with scoping reviews and evidence updates.
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Reanimación Cardiopulmonar , Servicios Médicos de Urgencia , Paro Cardíaco Extrahospitalario , Nacimiento Prematuro , Adulto , Femenino , Niño , Recién Nacido , Humanos , Primeros Auxilios , Consenso , Paro Cardíaco Extrahospitalario/diagnóstico , Paro Cardíaco Extrahospitalario/terapiaRESUMEN
Neonatal endotracheal intubation is a challenging procedure with suboptimal success and adverse event rates. Systematically tracking intubation outcomes is imperative to understand both universal and site-specific barriers to intubation success and safety. The National Emergency Airway Registry for Neonates (NEAR4NEOS) is an international registry designed to improve neonatal intubation practice and outcomes that includes over 17,000 intubations across 23 international sites as of 2023. Methods to improve intubation safety and success include appropriately matching the intubation provider and situation and increasing adoption of evidence-based practices such as muscle relaxant premedication and video laryngoscope, and potentially new interventions such as procedural oxygenation.
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Intubación Intratraqueal , Recién Nacido , Humanos , Intubación Intratraqueal/efectos adversos , Intubación Intratraqueal/métodos , Sistema de Registros , Estudios ProspectivosRESUMEN
INTRODUCTION: Nearly half of neonatal intubations are complicated by severe desaturation (≥20% decline in pulse oximetry saturation (SpO2)). Apnoeic oxygenation prevents or delays desaturation during intubation in adults and older children. Emerging data show mixed results for apnoeic oxygenation using high-flow nasal cannula (NC) during neonatal intubation. The study objective is to determine among infants ≥28 weeks' corrected gestational age (cGA) who undergo intubation in the neonatal intensive care unit (NICU) whether apnoeic oxygenation with a regular low-flow NC, compared with standard of care (no additional respiratory support), reduces the magnitude of SpO2 decline during intubation. METHODS AND ANALYSIS: This is a multicentre, prospective, unblinded, pilot randomised controlled trial in infants ≥28 weeks' cGA who undergo premedicated (including paralytic) intubation in the NICU. The trial will recruit 120 infants, 10 in the run-in phase and 110 in the randomisation phase, at two tertiary care hospitals. Parental consent will be obtained for eligible patients prior to intubation. Patients will be randomised to 6 L NC 100% oxygen versus standard of care (no respiratory support) at time of intubation. The primary outcome is magnitude of oxygen desaturation during intubation. Secondary outcomes include additional efficacy, safety and feasibility outcomes. Ascertainment of the primary outcome is performed blinded to intervention arm. Intention-to-treat analyses will be conducted to compare outcomes between treatment arms. Two planned subgroup analyses will explore the influence of first provider intubation competence and patients' baseline lung disease using pre-intubation respiratory support as a proxy. ETHICS AND DISSEMINATION: The Institutional Review Boards at the Children's Hospital of Philadelphia and the University of Pennsylvania have approved the study. Upon completion of the trial, we intend to submit our primary results to a peer review forum after which we plan to publish our results in a peer-reviewed paediatric journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05451953).