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OBJECTIVE: To define percentile charts for arterial oxygen saturation (SpO2), heart rate (HR), and cerebral oxygen saturation (crSO2) during the first 15 minutes after birth in neonates born very or extremely preterm and with favorable outcome. STUDY DESIGN: We conducted a secondary-outcome analysis of neonates born preterm included in the Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth III (COSGOD III) trial with visible cerebral oximetry measurements and with favorable outcome, defined as survival without cerebral injuries until term age. We excluded infants with inflammatory morbidities within the first week after birth. SpO2 was obtained by pulse oximetry, and electrocardiogram or pulse oximetry were used for measurement of HR. crSO2 was assessed with near-infrared spectroscopy. Measurements were performed during the first 15 minutes after birth. Percentile charts (10th to 90th centile) were defined for each minute. RESULTS: A total of 207 neonates born preterm with a gestational age of 29.7 (23.9-31.9) weeks and a birth weight of 1200 (378-2320) g were eligible for analyses. The 10th percentile of SpO2 at minute 2, 5, 10, and 15 was 32%, 52%, 83%, and 85%, respectively. The 10th percentile of HR at minute 2, 5, 10, and 15 was 70, 109, 126, and 134 beats/min, respectively. The 10th percentile of crSO2 at minute 2, 5, 20, and 15 was 15%, 27%, 59%, and 63%, respectively. CONCLUSIONS: This study provides new centile charts for SpO2, HR, and crSO2 for neonates born extremely or very preterm with favorable outcome. Implementing these centiles in guiding interventions during the stabilization process after birth might help to more accurately target oxygenation during postnatal transition period.
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BACKGROUND: To compare tidal volume (VT) delivery with compliance at 0.5 and 1.5 mL/cmH2O using four different ventilation (PPV) devices (i.e., self-inflating bag (SIB), T-Piece resuscitator, Next Step (a novel Neonatal Resuscitator), and Fabian ventilator (conventional neonatal ventilator) using a neonatal piglet model. DESIGN/METHODS: Randomized experimental animal study using 10 mixed-breed neonatal piglets (1-3 days; 1.8-2.4 kg). Piglets were anesthetized, intubated, instrumented, and randomized to receive positive pressure ventilation (PPV) for one minute with a SIB with or without a respiratory function monitor (RFM), T-Piece resuscitator with or without an RFM, Next Step, and Fabian Ventilator with both compliance levels. Compliance changes were achieved by placing a wrap around the piglets' chest and tightened it. Our primary outcome was targeted VT delivery of 5 mL/kg at 0.5 and 1.5 mL/cmH2O lung compliance. RESULTS: At 0.5 mL/cmH2O compliance, the mean(SD) expired VT with the Next Step was 5.1(0.2) mL/kg compared to the Fabian 4.8(0.5) mL/kg, SIB 8.9(3.6) mL/kg, SIB + RFM 4.5(1.8) mL/kg, T-Piece 7.4(4.3) mL/kg, and T-Piece+RFM 6.4(3.1) mL/kg. At 1.5 mL/cmH2O compliance, the mean(SD) expired VT with the Next Step was 5.2(0.6) mL/kg compared to the Fabian 4.4(0.7) mL/kg, SIB 12.1(5.3) mL/kg, SIB + RFM 9.4(3.9) mL/kg, T-Piece 8.6(1.5) mL/kg, and T-Piece+RFM 6.5 (1.6) mL/kg. CONCLUSION: The Next Step provides consistent VT during PPV, which is comparable to a mechanical ventilator. IMPACT: Current guidelines recommend fixed peak inflation pressure in resuscitation, linked to lung and brain injury. The Next Step Neonatal Resuscitator, a cost-effective device, offers volume-targeted positive pressure ventilation with consistent tidal volumes. With two different compliances, the Next Step Neonatal Resuscitator delivered a consistent tidal volume which was similar to a mechanical ventilator. The Next Step Neonatal Resuscitator outperformed self-inflating bags and T-Pieces in delivering targeted tidal volumes. The Next Step Neonatal Resuscitator could be an alternative ventilation device for neonatal resuscitation.
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Animales Recién Nacidos , Respiración con Presión Positiva , Volumen de Ventilación Pulmonar , Animales , Respiración con Presión Positiva/instrumentación , Porcinos , Rendimiento Pulmonar , Ovinos , Pulmón/fisiología , Ventiladores Mecánicos , Diseño de Equipo , Modelos AnimalesRESUMEN
BACKGROUND: Delayed cord clamping and umbilical cord milking provide placental transfusion to vigorous newborns. Delayed cord clamping in nonvigorous newborns may not be provided owing to a perceived need for immediate resuscitation. Umbilical cord milking is an alternative, as it can be performed more quickly than delayed cord clamping and may confer similar benefits. OBJECTIVE: We hypothesized that umbilical cord milking would reduce admission to the neonatal intensive care unit compared with early cord clamping in nonvigorous newborns born between 35 and 42 weeks' gestation. STUDY DESIGN: This was a pragmatic cluster-randomized crossover trial of infants born at 35 to 42 weeks' gestation in 10 medical centers in 3 countries between January 2019 and May 2021. The centers were randomized to umbilical cord milking or early cord clamping for approximately 1 year and then crossed over for an additional year or until the required number of consented subjects was reached. Waiver of consent as obtained in all centers to implement the intervention. Infants were eligible if nonvigorous at birth (poor tone, pale color, or lack of breathing in the first 15 seconds after birth) and were assigned to umbilical cord milking or early cord clamping according to their birth hospital randomization assignment. The baseline characteristics and outcomes were collected following deferred informed consent. The primary outcome was admission to the neonatal intensive care unit for predefined criteria. The main safety outcome was hypoxic-ischemic encephalopathy. Data were analyzed by the intention-to-treat concept. RESULTS: Among 16,234 screened newborns, 1780 were eligible (905 umbilical cord milking, 875 early cord clamping), and 1730 had primary outcome data for analysis (97% of eligible; 872 umbilical cord milking, 858 early cord clamping) either via informed consent (606 umbilical cord milking, 601 early cord clamping) or waiver of informed consent (266 umbilical cord milking, 257 early cord clamping). The difference in the frequency of neonatal intensive care unit admission using predefined criteria between the umbilical cord milking (23%) and early cord clamping (28%) groups did not reach statistical significance (modeled odds ratio, 0.69; 95% confidence interval, 0.41-1.14). Umbilical cord milking was associated with predefined secondary outcomes, including higher hemoglobin (modeled mean difference between umbilical cord milking and early cord clamping groups 0.68 g/dL, 95% confidence interval, 0.31-1.05), lower odds of abnormal 1-minute Apgar scores (Apgar ≤3, 30% vs 34%, crude odds ratio, 0.72; 95% confidence interval, 0.56-0.92); cardiorespiratory support at delivery (61% vs 71%, modeled odds ratio, 0.57; 95% confidence interval, 0.33-0.99), and therapeutic hypothermia (3% vs 4%, crude odds ratio, 0.57; 95% confidence interval, 0.33-0.99). Moderate-to-severe hypoxic-ischemic encephalopathy was significantly less common with umbilical cord milking (1% vs 3%, crude odds ratio, 0.48; 95% confidence interval, 0.24-0.96). No significant differences were observed for normal saline bolus, phototherapy, abnormal 5-minute Apgar scores (Apgar ≤6, 15.7% vs 18.8%, crude odds ratio, 0.81; 95% confidence interval, 0.62-1.06), or a serious adverse event composite of death before discharge. CONCLUSION: Among nonvigorous infants born at 35 to 42 weeks' gestation, umbilical cord milking did not reduce neonatal intensive care unit admission for predefined criteria. However, infants in the umbilical cord milking arm had higher hemoglobin, received less delivery room cardiorespiratory support, had a lower incidence of moderate-to-severe hypoxic-ischemic encephalopathy, and received less therapeutic hypothermia. These data may provide the first randomized controlled trial evidence that umbilical cord milking in nonvigorous infants is feasible, safe and, superior to early cord clamping.
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Enfermedades del Recién Nacido , Clampeo del Cordón Umbilical , Cordón Umbilical , Femenino , Humanos , Recién Nacido , Embarazo , Transfusión Sanguínea , Constricción , Estudios Cruzados , Hemoglobinas , Hipoxia-Isquemia Encefálica/etiología , Recien Nacido Prematuro , Placenta , Cordón Umbilical/cirugía , Clampeo del Cordón Umbilical/métodos , Enfermedades del Prematuro/cirugía , Enfermedades del Prematuro/terapia , Enfermedades del Recién Nacido/cirugía , Enfermedades del Recién Nacido/terapiaRESUMEN
OBJECTIVE: Mask positive pressure ventilation (PPV) in the delivery room is routinely delivered with set peak inflation pressures. To aid mask PPV, stand-alone respiratory function monitors (RFMs) have been used in the delivery room, while ventilator-based, volume-targeted ventilation (VTV) is routinely used in the neonatal intensive care unit (NICU). DESIGN: This is a prospective, randomised, crossover simulation study. Participants were briefly trained to use a neonatal ventilator for volume-targeted mask ventilation (VTV-PPV), then performed mask ventilation on a manikin in a randomised order using VTV-PPV, T-piece PPV or T-piece PPV with RFM visible. SETTING: In situ in a neonatal resuscitation room within a level 3 NICU. PARTICIPANTS: Healthcare professionals (HCPs) trained in neonatal resuscitation with experience as team leaders. INTERVENTIONS: Semiautomated, ventilator-based VTV-PPV using two-hand hold versus manual PPV via a T-piece device (T-piece, RFM masked) versus manual PPV with RFM visible using one-hand hold. MAIN OUTCOME MEASURES: Respiratory characteristics including % mask leak, tidal volume (VT) and peak inflation pressure (PIP). RESULTS: Thirty-two HCPs (23 (72%) female and 9 (28%) male) participated. The median mask leak was significantly lower with 'VTV-PPV' (11%, IQR 0%-14%) compared with both 'T-piece, RFM visible' (82%, IQR 30%-91%) and 'T-piece, RFM masked' (81%, IQR 47%-91%) (p<0.0001). The median delivered VT was 4.1 mL/kg (IQR 3.9-4.4) with VTV-PPV compared with 2.1 mL/kg (IQR 1.2-9) with T-piece, RFM visible and 1.8 mL/kg (IQR 1.1-5.8) with T-piece, RFM masked (p=0.0496). PIP was also significantly lower with VTV-PPV. CONCLUSION: During neonatal simulation, VTV-PPV reduced mask leak and allowed for consistent VT delivery compared with T-piece with and without RFM guidance.
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Respiración con Presión Positiva , Resucitación , Recién Nacido , Masculino , Humanos , Femenino , Estudios Prospectivos , Respiración , Volumen de Ventilación PulmonarRESUMEN
Background: A new cardiopulmonary resuscitation technique, chest compressions with sustained inflation (CC + SI) might be an alternative to both the neonatal [3:1compressions to ventilations (3:1C:V)] and paediatric [chest compression with asynchronous ventilation (CCaV)] approaches. The human factors associated with this technique are unknown. We aimed to compare the physical, cognitive, and team-based human factors for CC + SI to standard CPR (3:1C:V or CCaV). Methods: Randomized crossover simulation study including 40 participants on 20 two-person teams. Workload [National Aeronautics and Space Administration Task Load Index (NASA-TLX)], crisis resource management skills (CRM) [Ottawa Global Rating Scale (OGRS)], and debrief analysis were compared. Results: There was no difference in paired NASA-TLX scores for any dimension between the CC + SI and standard, adjusting for CPR order. There was no difference in CRM scores for CC + SI compared to standard. Participants were less familiar with CC + SI although many found it simpler to perform, better for transitions/switching roles, and better for communication. Conclusions: The human factors are no more physically or cognitively demanding with CC + SI compared to standard CPR (NASA-TLX and participant debrief) and team performance was no different with CC + SI compared to standard CPR (OGRS score).
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OBJECTIVE: In newborn infants requiring chest compression (CC) in the delivery room (DR) does continuous CC superimposed by a sustained inflation (CC+SI) compared with a 3:1 compression:ventilation (3:1 C:V) ratio decreases time to return of spontaneous circulation (ROSC). DESIGN: International, multicenter, prospective, cluster cross-over randomised trial. SETTING: DR in four hospitals in Canada and Austria, PARTICIPANTS: Newborn infants >28 weeks' gestation who required CC. INTERVENTIONS: Hospitals were randomised to CC+SI or 3:1 C:V then crossed over to the other intervention. MAIN OUTCOME MEASURE: The primary outcome was time to ROSC, defined as the duration of CC until an increase in heart rate >60/min determined by auscultation of the heart, which was maintained for 60 s. Sample size of 218 infants (109/group) was sufficient to detect a clinically important 33% reduction (282 vs 420 s of CC) in time to ROSC. Analysis was intention-to-treat. RESULTS: Patient recruitment occurred between 19 October 2017 and 22 September 2022 and randomised 27 infants (CC+SI (n=12), 3:1 C:V (n=15), two (one per group) declined consent). All 11 infants in the CC+SI group and 12/14 infants in the 3:1 C:V group achieved ROSC in the DR. The median (IQR) time to ROSC was 90 (60-270) s and 615 (174-780) s (p=0.0502 (log rank), p=0.16 (cox proportional hazards regression)) with CC+SI and 3:1 C:V, respectively. Mortality was 2/11 (18.2%) with CC+SI versus 8/14 (57.1%) with 3:1 C:V (p=0.10 (Fisher's exact test), OR (95% CI) 0.17; (0.03 to 1.07)). The trial was stopped due to issues with ethics approval and securing trial insurance as well as funding reasons. CONCLUSION: The time to ROSC and mortality was not statistical different between CC+SI and 3:1 C:V. TRIAL REGISTRATION: NCT02858583.
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Asfixia Neonatal , Reanimación Cardiopulmonar , Estudios Cruzados , Humanos , Recién Nacido , Reanimación Cardiopulmonar/métodos , Femenino , Masculino , Asfixia Neonatal/terapia , Asfixia Neonatal/complicaciones , Estudios Prospectivos , Canadá , AustriaRESUMEN
Neonates requiring cardiopulmonary resuscitation (CPR) are at risk of mortality and neurodevelopmental injury. Poor outcomes following the need for chest compressions (CCs) in the delivery room prompt the critical need for improvements in resuscitation strategies. This article explores a technique of CPR which involves CCs with sustained inflation (CC+SI). Unique features of CC+SI include (1) improved tidal volume delivery, (2) passive ventilation during compressions, (3) uninterrupted compressions and (4) improved stability of cerebral blood flow during resuscitation. CC+SI has been shown in animal studies to have improved time to return of spontaneous circulation and reduced mortality without significant increase in markers of inflammation and injury in the lung and brain, compared with standard CPR. The mechanics of CCs, rate of compressions, ventilation strategies and compression-to-ventilation ratios are detailed here. A large randomised controlled trial comparing CC+SI versus the current 3:1 compression-to-ventilation ratio is needed, given the growing evidence of its potential benefits.
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OBJECTIVES: To determine parental perspectives in a trial with waived consent. STUDY DESIGN: Anonymous survey of birth parents with term infants who were randomized using a waiver of consent, administered after infant discharge. RESULTS: 121 (11%) survey responses were collected. Of the 121 responding parents 111 (92%) reported that this form of consent was acceptable and 116 (96%) reported feeling comfortable having another child participate in a similar study. 110 (91%) respondents reported that they both understood the information provided in the consent process and had enough time to consider participation. Four percent had a negative opinion on the study's effect on their child's health. CONCLUSIONS: Most responding parents reported both acceptability of this study design in the neonatal period and that the study had a positive effect on their child's health. Future work should investigate additional ways to involve parents and elicit feedback on varied methods of pediatric consent.
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Consentimiento Informado , Padres , Lactante , Recién Nacido , Niño , Humanos , Encuestas y Cuestionarios , Emociones , Proyectos de InvestigaciónRESUMEN
BACKGROUND: Immediately after birth, the oxygen saturation is between 30 and 50%, which then increases to 85-95% within the first 10 min. Over the last 10 years, recommendations regarding the ideal level of the initial fraction of inspired oxygen (FiO2) for resuscitation in preterm infants have changed from 1.0, to room air to low levels of oxygen (< 0.3), up to moderate concentrations (0.3-0.65). This leaves clinicians in a challenging position, and a large multi-center international trial of sufficient sample size that is powered to look at safety outcomes such as mortality and adverse neurodevelopmental outcomes is required to provide the necessary evidence to guide clinical practice with confidence. METHODS: An international cluster, cross-over randomized trial of initial FiO2 of 0.3 or 0.6 during neonatal resuscitation in preterm infants at birth to increase survival free of major neurodevelopmental outcomes at 18 and 24 months corrected age will be conducted. Preterm infants born between 230/7 and 286/7 weeks' gestation will be eligible. Each participating hospital will be randomized to either an initial FiO2 concentration of either 0.3 or 0.6 to recruit for up to 12 months' and then crossed over to the other concentration for up to 12 months. The intervention will be initial FiO2 of 0.6, and the comparator will be initial FiO2 of 0.3 during respiratory support in the delivery room. The sample size will be 1200 preterm infants. This will yield 80% power, assuming a type 1 error of 5% to detect a 25% reduction in relative risk of the primary outcome from 35 to 26.5%. The primary outcome will be a composite of all-cause mortality or the presence of a major neurodevelopmental outcome between 18 and 24 months corrected age. Secondary outcomes will include the components of the primary outcome (death, cerebral palsy, major developmental delay involving cognition, speech, visual, or hearing impairment) in addition to neonatal morbidities (severe brain injury, bronchopulmonary dysplasia; and severe retinopathy of prematurity). DISCUSSION: The use of supplementary oxygen may be crucial but also potentially detrimental to preterm infants at birth. The HiLo trial is powered for the primary outcome and will address gaps in the evidence due to its pragmatic and inclusive design, targeting all extremely preterm infants. Should 60% initial oxygen concertation increase survival free of major neurodevelopmental outcomes at 18-24 months corrected age, without severe adverse effects, this readily available intervention could be introduced immediately into clinical practice. TRIAL REGISTRATION: The trial was registered on January 31, 2019, at ClinicalTrials.gov with the Identifier: NCT03825835.
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Recién Nacido de muy Bajo Peso , Resucitación , Humanos , Lactante , Recién Nacido , Edad Gestacional , Recien Nacido Extremadamente Prematuro , Oxígeno , Resucitación/efectos adversos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Importance: Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic hypothermia in nonvigorous near-term and full-term infants. However, UCM postdischarge outcomes are not known. Objective: To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial. Design, Setting, and Participants: A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years. Intervention: UCM and ECC. Main Outcomes and Measures: Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used. Results: Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86). Conclusions and Relevance: In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns. Trial Registration: ClinicalTrials.gov Identifier: NCT03631940.
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Clampeo del Cordón Umbilical , Humanos , Femenino , Recién Nacido , Masculino , Lactante , Clampeo del Cordón Umbilical/métodos , Estudios Cruzados , Cordón Umbilical , Hipoxia-Isquemia Encefálica/terapia , PreescolarRESUMEN
Importance: Providing assisted ventilation during delayed umbilical cord clamping may improve outcomes for extremely preterm infants. Objective: To determine whether assisted ventilation in extremely preterm infants (23 0/7 to 28 6/7 weeks' gestational age [GA]) followed by cord clamping reduces intraventricular hemorrhage (IVH) or early death. Design, Setting, and Participants: This phase 3, 1:1, parallel-stratified randomized clinical trial conducted at 12 perinatal centers across the US and Canada from September 2, 2016, through February 21, 2023, assessed IVH and early death outcomes of extremely preterm infants randomized to receive 120 seconds of assisted ventilation followed by cord clamping vs delayed cord clamping for 30 to 60 seconds with ventilatory assistance afterward. Two analysis cohorts, not breathing well and breathing well, were specified a priori based on assessment of breathing 30 seconds after birth. Intervention: After birth, all infants received stimulation and suctioning if needed. From 30 to 120 seconds, infants randomized to the intervention received continuous positive airway pressure if breathing well or positive-pressure ventilation if not, with cord clamping at 120 seconds. Control infants received 30 to 60 seconds of delayed cord clamping followed by standard resuscitation. Main Outcomes and Measures: The primary outcome was any grade IVH on head ultrasonography or death before day 7. Interpretation by site radiologists was confirmed by independent radiologists, all masked to study group. To estimate the association between study group and outcome, data were analyzed using the stratified Cochran-Mantel-Haenszel test for relative risk (RR), with associations summarized by point estimates and 95% CIs. Results: Of 1110 women who consented to participate, 548 were randomized and delivered infants at GA less than 29 weeks. A total of 570 eligible infants were enrolled (median [IQR] GA, 26.6 [24.9-27.7] weeks; 297 male [52.1%]). Intraventricular hemorrhage or death occurred in 34.9% (97 of 278) of infants in the intervention group and 32.5% (95 of 292) in the control group (adjusted RR, 1.02; 95% CI, 0.81-1.27). In the prespecified not-breathing-well cohort (47.5% [271 of 570]; median [IQR] GA, 26.0 [24.7-27.4] weeks; 152 male [56.1%]), IVH or death occurred in 38.7% (58 of 150) of infants in the intervention group and 43.0% (52 of 121) in the control group (RR, 0.91; 95% CI, 0.68-1.21). There was no evidence of differences in death, severe brain injury, or major morbidities between the intervention and control groups in either breathing cohort. Conclusions and Relevance: This study did not show that providing assisted ventilation before cord clamping in extremely preterm infants reduces IVH or early death. Additional study around the feasibility, safety, and efficacy of assisted ventilation before cord clamping may provide additional insight. Trial Registration: ClinicalTrials.gov Identifier: NCT02742454.
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Recien Nacido Extremadamente Prematuro , Clampeo del Cordón Umbilical , Humanos , Recién Nacido , Femenino , Masculino , Clampeo del Cordón Umbilical/métodos , Canadá , Respiración Artificial/métodos , Hemorragia Cerebral Intraventricular/prevención & control , Cordón Umbilical , Presión de las Vías Aéreas Positiva Contínua/métodos , Edad Gestacional , Factores de Tiempo , Estados UnidosRESUMEN
Introduction: Emergency neonatal resuscitation equipment is often organized into "code carts". Simulation studies previously examined human factors of neonatal code carts and equipment; however, visual attention analysis with eye-tracking might further inform equipment design. Objectives: To evaluate human factors of neonatal resuscitation equipment by: (1) comparing epinephrine preparation speed from adult pre-filled syringe vs. medication vial, (2) comparing equipment retrieval times from two carts and (3) utilizing eye-tracking to study visual attention and user experience. Methods: We conducted a 2-site randomized cross-over simulation study. Site 1 is a perinatal NICU with carts focused on airway management. Site 2 is a surgical NICU with carts improved with compartments and task-based kits. Participants were fitted with eye-tracking glasses then randomized to prepare two epinephrine doses using two methods, starting with an adult epinephrine prefilled syringe or a multiple access vial. Participants then obtained items for 7 tasks from their local cart. Post-simulation, participants completed surveys and semi-structured interviews while viewing eye-tracked video of their performance. Epinephrine preparation times were compared between the two methods. Equipment retrieval times and survey responses were compared between sites. Eye-tracking was analyzed for areas of interest (AOIs) and gaze shifts between AOIs. Interviews were subject to thematic analysis. Results: Forty HCPs participated (20/site). It was faster to draw the first epinephrine dose using the medication vial (29.9s vs. 47.6s, p < 0.001). Time to draw the second dose was similar (21.2s vs. 19s, p = 0.563). It was faster to obtain equipment from the Perinatal cart (164.4s v 228.9s, p < 0.027). Participants at both sites found their carts easy to use. Participants looked at many AOIs (54 for Perinatal vs. 76 for Surgical carts, p < 0.001) with 1 gaze shifts/second for both.Themes for epinephrine preparation include: Facilitators and Threats to Performance, and Discrepancies due to Stimulation Conditions. Themes for code carts include: Facilitators and Threats to Performance, Orienting with Prescan, and Suggestions for Improvement. Suggested cart improvements include: adding prompts, task-based grouping, and positioning small equipment more visibly. Task-based kits were welcomed, but more orientation is needed. Conclusions: Eye-tracked simulations provided human factors assessment of emergency neonatal code carts and epinephrine preparation.
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OBJECTIVE: To use simulations to compare a novel mask ventilation method using a neonatal ventilator, with mask ventilation using a T-piece resuscitator, to study human factors prior to clinical testing. DESIGN: Prospective randomised cross-over simulation study. Participants were briefly trained to use a neonatal ventilator for mask ventilation. Each participant was fitted with eye-tracking glasses to record visual attention (VA) and performed two simulated preterm neonatal resuscitations in a randomised sequence. SETTING: In situ in a neonatal resuscitation room within a Level 3 neonatal intensive care unit. PARTICIPANTS: Healthcare professionals (HCPs) trained in neonatal resuscitation with experience as team leaders. INTERVENTIONS: Semiautomated, ventilator-based, volume-targeted positive pressure mask ventilation (VTV-PPV) versus manual mask ventilation via T-piece device (T-piece PPV). MAIN OUTCOME MEASURES: Subjective workload (Surgical Task Load Index, SURG-TLX), VA, quantitative and qualitative postsimulation survey responses. RESULTS: Thirty HCPs participated. HCPs reported higher total SURG-TLX scores (43.5/120 vs 33.8/120) and higher scores in mental demand (8.2/20 vs 5.6/20), physical demand (6.6/20 vs 5.1/20), task complexity (8.2/20 vs 6/20) and situational stress (8.3/20 vs 5.9/20) for VTV-PPV. Temporal demand and distraction scores were similar. While participants took longer to complete VTV-PPV simulations, participants dedicated similar a %VA to the mannikin and T-piece gauges or ventilator screen. More participants increased the rate of ventilation during VTV-PPV; other corrective steps were similar. Overall, participants rated VTV-PPV positively. Participants identified potential challenges with physical ergonomics, cognition and teamwork. CONCLUSION: Using a neonatal ventilator to perform volume-targeted PPV is feasible, but human factors need to be considered.
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Respiración Artificial , Resucitación , Recién Nacido , Humanos , Resucitación/métodos , Estudios Prospectivos , Respiración con Presión Positiva/métodos , Ventiladores MecánicosRESUMEN
OBJECTIVE: A large, randomized cluster cross-over trial (N = 1730) comparing intact umbilical cord milking (UCM) to early cord clamping (ECC) in non-vigorous near-term/term newborns demonstrated a reduction in cardiorespiratory interventions at birth and less moderate to severe hypoxic ischemic encephalopathy. We evaluated changes in cerebral tissue oxygenation (StO2), pulse oximetry (SpO2), pulse rate and fraction of inspired oxygen (FiO2) during the first 10 min of life in a subset of infants enrolled in the parent trial. STUDY DESIGN: Infants enrolled in the Milking in Non-Vigorous Infants trial that had StO2 monitoring at birth were included in the sub-study conducted at 3 hospitals the US and Canada. A near-infrared spectroscopy sensor, pulse oximeter and electrocardiogram electrodes were placed. Pulse rate, StO2, SpO2, and FiO2 were collected for the first 10 min after birth. Longitudinal models were used to compare effects of UCM and ECC. RESULTS: Thirty-four infants had StO2 data. Fifteen of these infants received UCM and 19 had ECC. Infants receiving UCM had similar heart rates, SpO2, and StO2 values, but were exposed to less FiO2 over the first 10 min of life than infants with ECC (0.26 ± 0.12 vs. 0.81 ± 0.05 at 10 min). CONCLUSION: Non-vigorous term/near term infants who received UCM at birth required lower FiO2 after delivery when compared to infants who umbilical cords were clamped soon after birth while achieving similar peripheral and cerebral oxygenation. Cord milking may be a potential option for placental transfusion in non-vigorous near term/term infants when delayed cord clamping cannot be performed.
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Recien Nacido Prematuro , Clampeo del Cordón Umbilical , Lactante , Recién Nacido , Embarazo , Humanos , Femenino , Estudios Cruzados , Constricción , Placenta , Hemodinámica/fisiología , Cordón Umbilical/fisiologíaRESUMEN
INTRODUCTION: Low pressure nasal continuous positive airway pressure (nCPAP) has long been the mainstay of non-invasive respiratory support for preterm neonates, at a constant distending pressure of 5-8 cmH2O. When traditional nCPAP pressures are insufficient, other modes including nasal intermittent positive pressure ventilation (NIPPV) are used. In recent years, high nCPAP pressures (≥9 cmH2O) have also emerged as an alternative. However, the comparative benefits and risks of these modalities remain unknown. METHODS AND ANALYSIS: In this multicentre pilot randomised controlled trial, infants <29 weeks' gestational age (GA) who either: (A) fail treatment with traditional nCPAP or (B) being extubated from invasive mechanical ventilation with mean airway pressure ≥10 cmH2O, will be randomised to receive either high nCPAP (positive end-expiratory pressure 9-15 cmH2O) or NIPPV (target mean Paw 9-15 cmH2O). Primary outcome is feasibility of the conduct of a larger, definitive trial as assessed by rates of recruitment and protocol violations. The main secondary outcome is failure of assigned treatment within 7 days postrandomisation. Multiple other clinical outcomes including bronchopulmonary dysplasia will be ascertained. All randomised participants will be analysed using intention to treat. Baseline and demographic variables as well as outcomes will be summarised and compared using univariate analyses, and a p<0.05 will be considered significant. ETHICS AND DISSEMINATION: The trial has been approved by the respective research ethics boards at each institution (McMaster Children's Hospital: Hamilton integrated REB approval #2113; Royal Alexandra Hospital: Health Research Ethics Board approval ID Pro00090244; Westmead Hospital: Human Research Ethics Committee approval ID 2022/ETH01343). Written, informed consent will be obtained from all parents/guardians prior to study enrolment. The findings of this pilot study will be disseminated via presentations at national and international conferences and via publication in a peer-reviewed journal. Social media platforms including Twitter will also be used to generate awareness. TRIAL REGISTRATION NUMBER: NCT03512158.
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Ventilación no Invasiva , Síndrome de Dificultad Respiratoria del Recién Nacido , Recién Nacido , Lactante , Niño , Humanos , Presión de las Vías Aéreas Positiva Contínua/métodos , Proyectos Piloto , Recien Nacido Prematuro , Ventilación con Presión Positiva Intermitente/métodos , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
Objectives: To determine parental perspectives in a trial with waived consent. Study Design: Biological parents of non-vigorous term infants randomized using a waiver of consent for a delivery room intervention completed an anonymous survey after discharge. Results: 121 survey responses were collected. Most responding parents reported that this form of consent was acceptable (92%) and that they would feel comfortable having another child participate in a similar study (96%). The majority (> 90%) also reported that the information provided after randomization was clear to understand future data collection procedures. Four percent had a negative opinion on the study's effect on their child's health. Conclusions: The majority of responding parents reported both acceptability of this study design in the neonatal period and that the study had a positive effect on their child's health. Future work should investigate additional ways to involve parents and elicit feedback on varied methods of pediatric consent.
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INTRODUCTION: Infants born with critical congenital heart defects (CCHDs) have unique transitional pathophysiology that often requires special resuscitation and management considerations in the delivery room (DR). While much is known about neonatal resuscitation of infants with CCHDs, current neonatal resuscitation guidelines such as the neonatal resuscitation programme (NRP) do not include algorithm modifications or education specific to CCHDs. The implementation of CCHD specific neonatal resuscitation education is further hampered by the large number of healthcare providers (HCPs) that need to be reached. Online learning modules (eLearning) may provide a solution but have not been designed or tested for this specific learning need. Our objective in this study is to design targeted eLearning modules for DR resuscitation of infants with specific CCHDs and compare HCP knowledge and team performance in simulated resuscitations among HCPs exposed to these modules compared with directed CCHD readings. METHODS AND ANALYSIS: In a prospective multicentre trial, HCP proficient in standard NRP education curriculum are randomised to either (a) directed CCHD readings or (b) CCHD eLearning modules developed by the study team. The efficacy of these modules will be evaluated using (a) individual preknowledge/postknowledge testing and (b) team-based resuscitation simulations. ETHICS AND DISSEMINATION: This study protocol is approved by nine participating sites: the Boston Children's Hospital Institutional Review Board (IRB-P00042003), University of Alberta Research Ethics Board (Pro00114424), the Children's Wisconsin IRB (1760009-1), Nationwide Children's Hospital IRB (STUDY00001518), Milwaukee Children's IRB (1760009-1) and University of Texas Southwestern IRB (STU-2021-0457) and is under review at following sites: University of Cincinnati, Children's Healthcare of Atlanta, Children's Hospital of Los Angeles and Children's Mercy-Kansas City. Study results will be disseminated to participating individuals in a lay format and presented to the scientific community at paediatric and critical care conferences and published in relevant peer-reviewed journals.
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Cardiopatías Congénitas , Resucitación , Lactante , Embarazo , Recién Nacido , Humanos , Niño , Femenino , Resucitación/métodos , Estudios Prospectivos , Salas de Parto , Aprendizaje , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como AsuntoRESUMEN
OBJECTIVE: To investigate whether monitoring of cerebral tissue oxygen saturation using near infrared spectroscopy in addition to routine monitoring combined with defined treatment guidelines during immediate transition and resuscitation increases survival without cerebral injury of premature infants compared with standard care alone. DESIGN: Multicentre, multinational, randomised controlled phase 3 trial. SETTING: 11 tertiary neonatal intensive care units in six countries in Europe and in Canada. PARTICIPANTS: 1121 pregnant women (<32 weeks' gestation) were screened prenatally. The primary outcome was analysed in 607 of 655 randomised preterm neonates: 304 neonates in the near infrared spectroscopy group and 303 in the control group. INTERVENTION: Preterm neonates were randomly assigned to either standard care (control group) or standard care plus monitoring of cerebral oxygen saturation with a dedicated treatment guideline (near infrared spectroscopy group) during immediate transition (first 15 minutes after birth) and resuscitation. MAIN OUTCOME MEASURE: The primary outcome, assessed using all cause mortality and serial cerebral ultrasonography, was a composite of survival without cerebral injury. Cerebral injury was defined as any intraventricular haemorrhage or cystic periventricular leukomalacia, or both, at term equivalent age or before discharge. RESULTS: Cerebral tissue oxygen saturation was similar in both groups. 252 (82.9%) out of 304 neonates (median gestational age 28.9 (interquartile range 26.9-30.6) weeks) in the near infrared spectroscopy group survived without cerebral injury compared with 238 (78.5%) out of 303 neonates (28.6 (26.6-30.6) weeks) in the control group (relative risk 1.06, 95% confidence interval 0.98 to 1.14). 28 neonates died (near infrared spectroscopy group 12 (4.0%) v control group 16 (5.3%): relative risk 0.75 (0.33 to 1.70). CONCLUSION: Monitoring of cerebral tissue oxygen saturation in combination with dedicated interventions in preterm neonates (<32 weeks' gestation) during immediate transition and resuscitation after birth did not result in substantially higher survival without cerebral injury compared with standard care alone. Survival without cerebral injury increased by 4.3% but was not statistically significant. TRIAL REGISTRATION: ClinicalTrials.gov NCT03166722.
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Lesiones Encefálicas , Oxígeno , Recién Nacido , Lactante , Humanos , Femenino , Embarazo , Encéfalo/diagnóstico por imagen , Saturación de Oxígeno , Recien Nacido Prematuro , Edad GestacionalRESUMEN
OBJECTIVES: To determine whether rate of severe intraventricular hemorrhage (IVH) or death among preterm infants receiving placental transfusion with UCM is noninferior to delayed cord clamping (DCC). METHODS: Noninferiority randomized controlled trial comparing UCM versus DCC in preterm infants born 28 to 32 weeks recruited between June 2017 through September 2022 from 19 university and private medical centers in 4 countries. The primary outcome was Grade III/IV IVH or death evaluated at a 1% noninferiority margin. RESULTS: Among 1019 infants (UCM n = 511 and DCC n = 508), all completed the trial from birth through initial hospitalization (mean gestational age 31 weeks, 44% female). For the primary outcome, 7 of 511 (1.4%) infants randomized to UCM developed severe IVH or died compared to 7 of 508 (1.4%) infants randomized to DCC (rate difference 0.01%, 95% confidence interval: (-1.4% to 1.4%), P = .99). CONCLUSIONS: In this randomized controlled trial of UCM versus DCC among preterm infants born between 28 and 32 weeks' gestation, there was no difference in the rates of severe IVH or death. UCM may be a safe alternative to DCC in premature infants born at 28 to 32 weeks who require resuscitation.