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1.
Circulation ; 149(1): e157-e166, 2024 01 02.
Artículo en Inglés | MEDLINE | ID: mdl-37970724

RESUMEN

This 2023 focused update to the neonatal resuscitation guidelines is based on 4 systematic reviews recently completed under the direction of the International Liaison Committee on Resuscitation Neonatal Life Support Task Force. Systematic reviewers and content experts from this task force performed comprehensive reviews of the scientific literature on umbilical cord management in preterm, late preterm, and term newborn infants, and the optimal devices and interfaces used for administering positive-pressure ventilation during resuscitation of newborn infants. These recommendations provide new guidance on the use of intact umbilical cord milking, device selection for administering positive-pressure ventilation, and an additional primary interface for administering positive-pressure ventilation.


Asunto(s)
Reanimación Cardiopulmonar , Servicios Médicos de Urgencia , Lactante , Niño , Recién Nacido , Humanos , Estados Unidos , Resucitación , American Heart Association , Tratamiento de Urgencia
2.
J Pediatr ; 273: 114132, 2024 May 31.
Artículo en Inglés | MEDLINE | ID: mdl-38823628

RESUMEN

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.

3.
Pediatr Res ; 2024 Jan 13.
Artículo en Inglés | MEDLINE | ID: mdl-38218928

RESUMEN

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.

4.
Pediatr Res ; 95(1): 156-159, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37741932

RESUMEN

BACKGROUND: High-quality chest compressions (CC) are an important factor of neonatal resuscitation. Mechanical CC devices may provide superior CC delivery and improve resuscitation outcomes. We aimed to compare the hemodynamic effects of CC delivered by machine and human using a neonatal piglet model. METHODS: Twelve asphyxiated piglets were randomized to receive CC during resuscitation using an automated mechanical CC device ("machine") or the two-thumb encircling technique ("human"). CC was superimposed with sustained inflations. RESULTS: Twelve newborn piglets (age 0-3 days, weight 2.12 ± 0.17 kg) were included in the study. Machine-delivered CC resulted in an increase in stroke volume, and minimum and maximum rate of left ventricle pressure change (dp/dtmin and dp/dtmax) compared to human-delivered CC. CONCLUSIONS: During machine-delivered CC, stroke volume and left ventricular contractility were significantly improved. Mechanical CC devices may provide improved cardiopulmonary resuscitation outcomes in neonatal cardiac arrest induced by asphyxia. IMPACT: Machine chest compression leads to changes in hemodynamic parameters during resuscitation of asphyxiated neonatal piglets, namely greater stroke volume and left ventricular contractility, compared with standard two-thumb compression technique. Mechanical chest compression devices may provide improved cardiopulmonary resuscitation outcomes in neonatal and pediatric asphyxia-induced cardiac arrest.


Asunto(s)
Asfixia , Reanimación Cardiopulmonar , Paro Cardíaco , Respiración Artificial , Animales , Humanos , Asfixia/terapia , Reanimación Cardiopulmonar/instrumentación , Reanimación Cardiopulmonar/métodos , Paro Cardíaco/terapia , Hemodinámica , Respiración Artificial/instrumentación , Respiración Artificial/métodos , Porcinos , Animales Recién Nacidos , Modelos Animales de Enfermedad
5.
Pediatr Res ; 95(4): 988-995, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-36932182

RESUMEN

BACKGROUND: Pediatric resuscitation guidelines recommend continuous chest compression with asynchronized ventilation (CCaV) during cardiopulmonary resuscitation. We recently described that providing a constant high distending pressure, or sustained inflation (SI) while performing continuous chest compressions (CC = CC + SI) reduces time to return of spontaneous circulation (ROSC) in neonatal and pediatric piglets with asphyxia-induced cardiac arrest. METHODS: To determine if CC + SI compared to CCaV will improve frequency of achieving ROSC and reduce time to ROSC in asphyxiated pediatric piglets. Twenty-eight pediatric piglets (21-24 days old) were anesthetized and asphyxiated by clamping the endotracheal tube. Piglets were randomized to CC + SI or CCaV for resuscitation (n = 14/group). Heart rate, arterial blood pressure, carotid blood flow, cerebral oxygenation, and respiratory parameters were continuously recorded throughout the experiment. RESULTS: The mean(SD) duration of resuscitation was significantly reduced with CC + SI compared to CCaV with 208(190) vs. 388(258)s, p = 0.045, respectively. The number of piglets achieving ROSC with CC + SI and CCaV were 12/14 vs. 6/14, p = 0.046. Minute ventilation, end-tidal carbon dioxide, ventilation rate, and positive end expiratory pressures were also significantly improved with CC + SI. CONCLUSIONS: CC + SI improves duration of resuscitation and increases number of piglets achieving ROSC secondary to improved minute ventilation. IMPACT: Chest compressions superimposed with sustained inflation resulted in shorter duration of resuscitation Chest compressions superimposed with sustained inflation resulted in higher number of piglets achieving return of spontaneous circulation Further animal studies are needed to examine chest compressions superimposed with sustained inflation.


Asunto(s)
Reanimación Cardiopulmonar , Paro Cardíaco , Humanos , Niño , Animales , Porcinos , Paro Cardíaco/terapia , Animales Recién Nacidos , Reanimación Cardiopulmonar/métodos , Asfixia/complicaciones , Asfixia/terapia , Respiración Artificial/métodos
6.
Am J Obstet Gynecol ; 228(2): 217.e1-217.e14, 2023 02.
Artículo en Inglés | MEDLINE | ID: mdl-35970202

RESUMEN

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.


Asunto(s)
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/terapia
7.
Pediatr Res ; 2023 Nov 08.
Artículo en Inglés | MEDLINE | ID: mdl-37940664

RESUMEN

BACKGROUND: Current neonatal resuscitation guidelines recommend epinephrine for cardiac arrest. Vasopressin might be an alternative during asphyxial cardiac arrest. We aimed to compare vasopressin and epinephrine on incidence and time to return of spontaneous circulation (ROSC) in asphyxiated newborn piglets. DESIGN/METHODS: Newborn piglets (n = 8/group) were anesthetized, intubated, instrumented, and exposed to 30 min of normocapnic hypoxia, followed by asphyxia and asystolic cardiac arrest. Piglets were randomized to 0.2, 0.4, or 0.8IU/kg vasopressin, or 0.02 mg/kg epinephrine. Hemodynamic parameters were continuously measured. RESULTS: Median (IQR) time to ROSC was 172(103-418)s, 157(100-413)s, 122(93-289)s, and 276(117-480)s for 0.2, 0.4, 0.8IU/kg vasopressin, and 0.02 mg/kg epinephrine groups, respectively (p = 0.59). The number of piglets that achieved ROSC was 6(75%), 6(75%), 7(88%), and 5(63%) for 0.2, 0.4, 0.8IU/kg vasopressin, and 0.02 mg/kg epinephrine, respectively (p = 0.94). The epinephrine group had a 60% (3/5) rate of post-ROSC survival compared to 83% (5/6), 83% (5/6), and 57% (4/7) in the 0.2, 0.4, and 0.8IU/kg vasopressin groups, respectively (p = 0.61). CONCLUSION: Time to and incidence of ROSC were not different between all vasopressin dosages and epinephrine. However, non-significantly lower time to ROSC and higher post-ROSC survival in vasopressin groups warrant further investigation. IMPACT: Time to and incidence of ROSC were not statistically different between all vasopressin dosages and epinephrine. Non-significantly lower time to ROSC and higher post-ROSC survival in vasopressin-treated piglets. Overall poorer hemodynamic recovery following ROSC in epinephrine piglets compared to vasopressin groups. Human neonatal clinical trials examining the efficacy of vasopressin during asphyxial cardiac arrest will begin recruitment soon.

8.
Pediatr Res ; 94(2): 443-449, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-36932183

RESUMEN

BACKGROUND: The aim was to assess health care providers' (HCPs) visual attention (VA) by using eye-tracking glasses during a simulated neonatal intubation. METHODS: HCPs from three pediatric and neonatal departments (Feldkirch and Vienna, Austria, and Edmonton, Canada) completed a simulated neonatal intubation scenario while wearing eye-tracking glasses (Tobii Pro Glasses 2®, Tobii, Stockholm, Sweden) to record their VA. Main outcomes included duration of intubation, success rate, and VA. We further compared orotracheal and nasotracheal intubations. RESULTS: 30 participants were included. 50% completed the intubation within 30 s (M = 35.40, SD = 16.01). Mostly nasotracheal intubations exceeded the limit. Experience was an important factor in reducing intubation time. VA differed between more and less experienced HCPs as well as between orotracheal and nasotracheal intubations. Participants also focused on different areas of interest (AOIs) depending on the intubator's experience. More experience was associated with a higher situational awareness (SA) and fewer distractions, which, however, did not transfer to significantly better intubation performance. CONCLUSION: Half of the intubations exceeded the recommended time limit. Differences in intubation duration depending on type of intubation were revealed. VA differed between HCPs with different levels of experience and depended on duration and type of intubation. IMPACT: Simulated neonatal intubation duration differs between orotracheal and nasotracheal intubation. Visual attention during simulated neonatal intubation shows differences depending on intubation duration, intubator experience, type of intubation, and level of distraction. Intubator experience is a vital parameter for reducing intubation duration and improving intubator focus on task-relevant stimuli.


Asunto(s)
Tecnología de Seguimiento Ocular , Intubación Intratraqueal , Recién Nacido , Humanos , Niño , Estudios Prospectivos , Personal de Salud , Factores de Tiempo
9.
Acta Paediatr ; 112(7): 1404-1412, 2023 07.
Artículo en Inglés | MEDLINE | ID: mdl-36880893

RESUMEN

AIM: To examine potential correlations between cardiac output (CO) with cerebral-regional-oxygen-saturation (crSO2 ) and cerebral-fractional-tissue-oxygen-extraction (cFTOE) during immediate foetal-to-neonatal transition in term and preterm neonates with and without respiratory support. METHODS: Post hoc analyses of secondary outcome parameters of prospective observational studies were performed. We included neonates with cerebral near-infrared-spectroscopy (NIRS) monitoring and an oscillometric blood pressure measurement at minute 15 after birth. Heart rate (HR) and arterial oxygen saturation (SpO2 ) were monitored. CO was calculated with Liljestrand and Zander formula and correlated with crSO2 and cFTOE. RESULTS: Seventy-nine preterm neonates and 207 term neonates with NIRS measurements and calculated CO were included. In 59 preterm neonates (mean gestational age (GA): 29.4 ± 3.7 weeks) with respiratory support, CO correlated significantly positively with crSO2 and significantly negatively with cFTOE. In 20 preterm neonates (GA 34.9 ± 1.3 weeks) without respiratory support and in 207 term neonates with and without respiratory support, CO correlated neither with crSO2 nor with cFTOE. CONCLUSION: In compromised preterm neonates with lower gestational age and in need of respiratory support, CO was associated with crSO2 and cFTOE, whereas in stable preterm neonates with higher gestational age as well as in term neonates with and without respiratory support, no associations were observed.


Asunto(s)
Recien Nacido Prematuro , Oxígeno , Recién Nacido , Femenino , Humanos , Recien Nacido Prematuro/fisiología , Encéfalo , Oximetría , Gasto Cardíaco , Circulación Cerebrovascular
10.
Acta Paediatr ; 112(3): 372-382, 2023 03.
Artículo en Inglés | MEDLINE | ID: mdl-36484640

RESUMEN

BACKGROUND: Clinicians favour low oxygen concentrations when resuscitating preterm infants immediately after birth despite inconclusive evidence to support this practice. Prospective meta-analysis (PMA) is a novel approach where studies are identified as eligible for inclusion in the meta-analysis before their results are known. AIMS: To explore whether high (60%) or low (30%) oxygen is associated with greater efficacy and safety for the initial resuscitation (immediately after birth) of preterm infants born at <29 weeks' gestation. METHODS: We will conduct a prospective meta-analysis (PMA) with individual participant data (IPD). We will perform a systematic search to identify ongoing RCTs including infants <29 weeks' gestation randomised to high (60%) or low (30%) oxygen for initial resuscitation after birth. IPD will be sought for all infants randomised for the purpose of meta-analysis. We will employ a one-stage random-effects approach to IPD meta-analysis. Potential heterogeneity and the differential effect of high or low oxygen will be explored through subgroup and interaction analyses. The primary outcome of this study is all-cause mortality prior to hospital discharge. There will be a follow-up analysis of neurodevelopmental outcomes once available. RESULTS/CONCLUSION: The results of neonatal outcomes at hospital discharge are expected by 2025, and neurodevelopmental outcomes by 2027.


Asunto(s)
Recien Nacido Prematuro , Oxígeno , Lactante , Femenino , Recién Nacido , Humanos , Estudios Prospectivos , Resucitación/métodos , Edad Gestacional , Metaanálisis como Asunto
11.
JAMA ; 330(11): 1054-1063, 2023 09 19.
Artículo en Inglés | MEDLINE | ID: mdl-37695601

RESUMEN

Importance: The long-term effects of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome remain to be definitively clarified. Objective: To examine the effect of MIST on death or neurodevelopmental disability (NDD) at 2 years' corrected age. Design, Setting, and Participants: Follow-up study of a randomized clinical trial with blinding of clinicians and outcome assessors conducted in 33 tertiary-level neonatal intensive care units in 11 countries. The trial included 486 infants with a gestational age of 25 to 28 weeks supported with continuous positive airway pressure (CPAP). Collection of follow-up data at 2 years' corrected age was completed on December 9, 2022. Interventions: Infants assigned to MIST (n = 242) received exogenous surfactant (200 mg/kg poractant alfa) via a thin catheter; those assigned to the control group (n = 244) received sham treatment. Main Outcomes and Measures: The key secondary outcome of death or moderate to severe NDD was assessed at 2 years' corrected age. Other secondary outcomes included components of this composite outcome, as well as hospitalizations for respiratory illness and parent-reported wheezing or breathing difficulty in the first 2 years. Results: Among the 486 infants randomized, 453 had follow-up data available (median gestation, 27.3 weeks; 228 females [50.3%]); data on the key secondary outcome were available in 434 infants. Death or NDD occurred in 78 infants (36.3%) in the MIST group and 79 (36.1%) in the control group (risk difference, 0% [95% CI, -7.6% to 7.7%]; relative risk [RR], 1.0 [95% CI, 0.81-1.24]); components of this outcome did not differ significantly between groups. Secondary respiratory outcomes favored the MIST group. Hospitalization with respiratory illness occurred in 49 infants (25.1%) in the MIST group vs 78 (38.2%) in the control group (RR, 0.66 [95% CI, 0.54-0.81]) and parent-reported wheezing or breathing difficulty in 73 (40.6%) vs 104 (53.6%), respectively (RR, 0.76 [95% CI, 0.63-0.90]). Conclusions and Relevance: In this follow-up study of a randomized clinical trial of preterm infants with respiratory distress syndrome supported with CPAP, MIST compared with sham treatment did not reduce the incidence of death or NDD by 2 years of age. However, infants who received MIST had lower rates of adverse respiratory outcomes during their first 2 years of life. Trial Registration: anzctr.org.au Identifier: ACTRN12611000916943.


Asunto(s)
Surfactantes Pulmonares , Síndrome de Dificultad Respiratoria del Recién Nacido , Femenino , Humanos , Lactante , Recién Nacido , Disnea , Estudios de Seguimiento , Recien Nacido Prematuro , Lipoproteínas , Surfactantes Pulmonares/administración & dosificación , Surfactantes Pulmonares/uso terapéutico , Síndrome de Dificultad Respiratoria/complicaciones , Síndrome de Dificultad Respiratoria/tratamiento farmacológico , Síndrome de Dificultad Respiratoria/terapia , Síndrome de Dificultad Respiratoria del Recién Nacido/complicaciones , Síndrome de Dificultad Respiratoria del Recién Nacido/tratamiento farmacológico , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Ruidos Respiratorios , Tensoactivos/administración & dosificación , Tensoactivos/uso terapéutico , Cateterismo , Procedimientos Quirúrgicos Mínimamente Invasivos , Presión de las Vías Aéreas Positiva Contínua , Masculino , Preescolar
12.
Am J Perinatol ; 39(8): 904-908, 2022 06.
Artículo en Inglés | MEDLINE | ID: mdl-33142340

RESUMEN

OBJECTIVE: This study aimed to determine whether outcomes differed between infants enrolled in the PREMOD2 trial and those otherwise eligible but not enrolled, and whether the use of waiver effected these differences. STUDY DESIGN: The multicenter PREMOD2 (PREmature infants receiving Milking Or Delayed cord clamping) trial was approved for waiver of antenatal consent by six of the nine sites institutional review boards, while three sites exclusively used antenatal consent. Every randomized subject delivered at a site with a waiver of consent was approached for postnatal consent to allow for data collection. Four of those six sites IRBs required the study team to attempt antenatal consent when possible. Three sites exclusively used antenatal consent. RESULTS: Enrolled subjects had higher Apgar scores, less use of positive pressure ventilation, a lower rate of bronchopulmonary dysplasia, and a less frequent occurrence of the combined outcome of severe intraventricular hemorrhage or death. A significantly greater number of infants were enrolled at sites with an option of waiver of consent (66 vs. 26%, risk ratio = 2.54, p < 0.001). At sites with an option of either approaching families before delivery or after delivery with a waiver of antenatal consent, those approached prior to delivery refused consent 40% (range 15-74% across six sites) of the time. CONCLUSION: PREMOD2 trial demonstrated analytical validity limitations because of the variable mix of antenatal consent and waiver of consent. A waiver of antenatal consent for minimal risk interventional trials conducted during the intrapartum period will be more successful in enrolling a representative sample of low and high-risk infants if investigators are able to enroll all eligible subjects. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03019367. KEY POINTS: · Waiver of consent is when informed consent cannot be obtained prior to delivery.. · Cord milking is a procedure in which blood is pushed (stripped) two to four times towards the newborn.. · Delayed clamping means the umbilical cord is not clamped immediately after birth..


Asunto(s)
Enfermedades del Prematuro , Recien Nacido Prematuro , Constricción , Femenino , Humanos , Lactante , Recién Nacido , Consentimiento Informado , Embarazo , Cordón Umbilical
13.
Circulation ; 142(16_suppl_1): S185-S221, 2020 10 20.
Artículo en Inglés | MEDLINE | ID: mdl-33084392

RESUMEN

This 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations (CoSTR) for neonatal life support includes evidence from 7 systematic reviews, 3 scoping reviews, and 12 evidence updates. The Neonatal Life Support Task Force generally determined by consensus the type of evidence evaluation to perform; the topics for the evidence updates followed consultation with International Liaison Committee on Resuscitation member resuscitation councils. The 2020 CoSTRs for neonatal life support are published either as new statements or, if appropriate, reiterations of existing statements when the task force found they remained valid. Evidence review topics of particular interest include the use of suction in the presence of both clear and meconium-stained amniotic fluid, sustained inflations for initiation of positive-pressure ventilation, initial oxygen concentrations for initiation of resuscitation in both preterm and term infants, use of epinephrine (adrenaline) when ventilation and compressions fail to stabilize the newborn infant, appropriate routes of drug delivery during resuscitation, and consideration of when it is appropriate to redirect resuscitation efforts after significant efforts have failed. All sections of the Neonatal Resuscitation Algorithm are addressed, from preparation through to postresuscitation care. This document now forms the basis for ongoing evidence evaluation and reevaluation, which will be triggered as further evidence is published. Over 140 million babies are born annually worldwide (https://ourworldindata.org/grapher/births-and-deaths-projected-to-2100). If up to 5% receive positive-pressure ventilation, this evidence evaluation is relevant to more than 7 million newborn infants every year. However, in terms of early care of the newborn infant, some of the topics addressed are relevant to every single baby born.


Asunto(s)
Reanimación Cardiopulmonar/normas , Enfermedades Cardiovasculares/terapia , Servicios Médicos de Urgencia/normas , Cuidados para Prolongación de la Vida/normas , Reanimación Cardiopulmonar/métodos , Epinefrina/administración & dosificación , Frecuencia Cardíaca , Humanos , Lactante , Saturación de Oxígeno , Respiración Artificial
14.
J Pediatr ; 239: 150-154.e1, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34453917

RESUMEN

OBJECTIVE: To characterize respiratory function monitor (RFM) measurements of sustained inflations and intermittent positive pressure ventilation (IPPV) delivered noninvasively to infants in the Sustained Aeration of Infant Lungs (SAIL) trial and to compare vital sign measurements between treatment arms. STUDY DESIGN: We analyzed RFM data from SAIL participants at 5 trial sites. We assessed tidal volumes, rates of airway obstruction, and mask leak among infants allocated to sustained inflations and IPPV, and we compared pulse rate and oxygen saturation measurements between treatment groups. RESULTS: Among 70 SAIL participants (36 sustained inflations, 34 IPPV) with RFM measurements, 40 (57%) were spontaneously breathing prior to the randomized intervention. The median expiratory tidal volume of sustained inflations administered was 5.3 mL/kg (IQR 1.1-9.2). Significant mask leak occurred in 15% and airway obstruction occurred during 17% of sustained inflations. Among 34 control infants, the median expiratory tidal volume of IPPV inflations was 4.3 mL/kg (IQR 1.3-6.6). Mask leak was present in 3%, and airway obstruction was present in 17% of IPPV inflations. There were no significant differences in pulse rate or oxygen saturation measurements between groups at any point during resuscitation. CONCLUSION: Expiratory tidal volumes of sustained inflations and IPPV inflations administered in the SAIL trial were highly variable in both treatment arms. Vital sign values were similar between groups throughout resuscitation. Sustained inflation as operationalized in the SAIL trial was not superior to IPPV to promote lung aeration after birth in this study subgroup. TRIAL REGISTRATION: Clinicaltrials.gov: NCT02139800.


Asunto(s)
Presión de las Vías Aéreas Positiva Contínua/métodos , Ventilación con Presión Positiva Intermitente/métodos , Resucitación/métodos , Presión de las Vías Aéreas Positiva Contínua/efectos adversos , Femenino , Edad Gestacional , Humanos , Recien Nacido Extremadamente Prematuro , Recién Nacido , Recien Nacido Prematuro , Ventilación con Presión Positiva Intermitente/efectos adversos , Masculino , Pruebas de Función Respiratoria
15.
Pediatr Res ; 2021 Oct 20.
Artículo en Inglés | MEDLINE | ID: mdl-34667270

RESUMEN

BACKGROUND: The aim of this systematic qualitative review was to give an overview of reference ranges defined as normal values or centile charts of regional tissue oxygen saturation measured by near-infrared spectroscopy (NIRS) in term and preterm neonates. METHODS: A systematic search of MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials was performed. Additional articles were identified by manual search of cited references. Only human studies in neonates were included. RESULTS: Nineteen studies were identified. Eight described regional tissue oxygen saturation during fetal-to-neonatal transition, six during the first 3 days after birth, four during the first 7 days after birth, and one during the first 8 weeks after birth. Nine described regional tissue oxygen saturation in term, nine in preterm neonates, and one in both. Eight studies published centile charts for cerebral regional tissue oxygen saturation, and only five included large cohorts of infants. Eleven studies described normal values for cerebral, muscle, renal, and abdominal regional tissue oxygen saturation, the majority with small sample sizes. Four studies of good methodological quality were identified describing centile charts of cerebral regional tissue oxygen saturation. CONCLUSIONS: In clinical settings, quality centile charts are available and should be the preferred method when using NIRS monitoring. IMPACT: Near-infrared spectroscopy (NIRS) enables a bed-side non-invasive continuous monitoring of tissue oxygenation. When using NIRS monitoring in a clinical setting, centile charts with good quality are available and should be preferred to normal values. High-quality reference ranges of regional tissue oxygenation in term and preterm born neonates are an important step toward routine clinical application of NIRS.

16.
Acta Paediatr ; 110(12): 3261-3268, 2021 12.
Artículo en Inglés | MEDLINE | ID: mdl-34473855

RESUMEN

AIM: The aim of this study was to determine clinician opinion regarding oxygen management in moderate-late preterm resuscitation. METHODS: An anonymous online questionnaire was distributed through email/social messaging platforms to neonatologists in 21 countries (October 2020-March 2021) via REDCap. RESULTS: Of the 695 respondents, 69% had access to oxygen blenders and 90% had pulse oximeters. Respondents from high-income countries were more likely to have oxygen blenders than those from middle-income countries (72% vs. 66%). Most initiated respiratory support with FiO2 0.21 (43%) or 0.3 (36%) but only 45% titrated FiO2 to target SpO2 . Most (89%) considered heart rate as a more important indicator of response than SpO2 . Almost all (96%) supported the need for well-designed trials to examine oxygenation in moderate-late preterm resuscitation. CONCLUSION: Most clinicians resuscitated moderate-late preterm infants with lower initial FiO2 but some cannot/will not target SpO2 or titrate FiO2 . Most consider heart rate as a more important indicator of infant response than SpO2 .Large and robust clinical trials examining oxygen use for moderate-late preterm resuscitation, including long-term neurodevelopmental outcomes, are supported amongst clinicians.


Asunto(s)
Salas de Parto , Oxígeno , Femenino , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Oximetría , Embarazo , Resucitación , Encuestas y Cuestionarios
17.
JAMA ; 326(24): 2478-2487, 2021 12 28.
Artículo en Inglés | MEDLINE | ID: mdl-34902013

RESUMEN

Importance: The benefits of surfactant administration via a thin catheter (minimally invasive surfactant therapy [MIST]) in preterm infants with respiratory distress syndrome are uncertain. Objective: To examine the effect of selective application of MIST at a low fraction of inspired oxygen threshold on survival without bronchopulmonary dysplasia (BPD). Design, Setting, and Participants: Randomized clinical trial including 485 preterm infants with a gestational age of 25 to 28 weeks who were supported with continuous positive airway pressure (CPAP) and required a fraction of inspired oxygen of 0.30 or greater within 6 hours of birth. The trial was conducted at 33 tertiary-level neonatal intensive care units around the world, with blinding of the clinicians and outcome assessors. Enrollment took place between December 16, 2011, and March 26, 2020; follow-up was completed on December 2, 2020. Interventions: Infants were randomized to the MIST group (n = 241) and received exogenous surfactant (200 mg/kg of poractant alfa) via a thin catheter or to the control group (n = 244) and received a sham (control) treatment; CPAP was continued thereafter in both groups unless specified intubation criteria were met. Main Outcomes and Measures: The primary outcome was the composite of death or physiological BPD assessed at 36 weeks' postmenstrual age. The components of the primary outcome (death prior to 36 weeks' postmenstrual age and BPD at 36 weeks' postmenstrual age) also were considered separately. Results: Among the 485 infants randomized (median gestational age, 27.3 weeks; 241 [49.7%] female), all completed follow-up. Death or BPD occurred in 105 infants (43.6%) in the MIST group and 121 (49.6%) in the control group (risk difference [RD], -6.3% [95% CI, -14.2% to 1.6%]; relative risk [RR], 0.87 [95% CI, 0.74 to 1.03]; P = .10). Incidence of death before 36 weeks' postmenstrual age did not differ significantly between groups (24 [10.0%] in MIST vs 19 [7.8%] in control; RD, 2.1% [95% CI, -3.6% to 7.8%]; RR, 1.27 [95% CI, 0.63 to 2.57]; P = .51), but incidence of BPD in survivors to 36 weeks' postmenstrual age was lower in the MIST group (81/217 [37.3%] vs 102/225 [45.3%] in the control group; RD, -7.8% [95% CI, -14.9% to -0.7%]; RR, 0.83 [95% CI, 0.70 to 0.98]; P = .03). Serious adverse events occurred in 10.3% of infants in the MIST group and 11.1% in the control group. Conclusions and Relevance: Among preterm infants with respiratory distress syndrome supported with CPAP, minimally invasive surfactant therapy compared with sham (control) treatment did not significantly reduce the incidence of the composite outcome of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age. However, given the statistical uncertainty reflected in the 95% CI, a clinically important effect cannot be excluded. Trial Registration: anzctr.org.au Identifier: ACTRN12611000916943.


Asunto(s)
Productos Biológicos/administración & dosificación , Displasia Broncopulmonar/prevención & control , Presión de las Vías Aéreas Positiva Contínua , Recien Nacido Prematuro , Fosfolípidos/administración & dosificación , Surfactantes Pulmonares/administración & dosificación , Síndrome de Dificultad Respiratoria del Recién Nacido/tratamiento farmacológico , Femenino , Humanos , Recién Nacido , Enfermedades del Prematuro/mortalidad , Masculino , Síndrome de Dificultad Respiratoria del Recién Nacido/mortalidad , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Método Simple Ciego
18.
Circulation ; 140(24): e922-e930, 2019 12 10.
Artículo en Inglés | MEDLINE | ID: mdl-31724451

RESUMEN

This 2019 focused update to the American Heart Association neonatal resuscitation guidelines is based on 2 evidence reviews recently completed under the direction of the International Liaison Committee on Resuscitation Neonatal Life Support Task Force. The International Liaison Committee on Resuscitation Expert Systematic Reviewer and content experts performed comprehensive reviews of the scientific literature on the appropriate initial oxygen concentration for use during neonatal resuscitation in 2 groups: term and late-preterm newborns (≥35 weeks of gestation) and preterm newborns (<35 weeks of gestation). This article summarizes those evidence reviews and presents recommendations. The recommendations for neonatal resuscitation are as follows: In term and late-preterm newborns (≥35 weeks of gestation) receiving respiratory support at birth, the initial use of 21% oxygen is reasonable. One hundred percent oxygen should not be used to initiate resuscitation because it is associated with excess mortality. In preterm newborns (<35 weeks of gestation) receiving respiratory support at birth, it may be reasonable to begin with 21% to 30% oxygen and to base subsequent oxygen titration on oxygen saturation targets. These guidelines require no change in the Neonatal Resuscitation Algorithm-2015 Update.


Asunto(s)
Reanimación Cardiopulmonar/normas , Servicios Médicos de Urgencia/normas , Guías como Asunto , Paro Cardíaco Extrahospitalario/terapia , American Heart Association , Servicio de Urgencia en Hospital/normas , Tratamiento de Urgencia/normas , Humanos , Paro Cardíaco Extrahospitalario/mortalidad , Estados Unidos
19.
J Pediatr ; 223: 51-56.e1, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32482392

RESUMEN

OBJECTIVE: To evaluate changes in cerebral oxygenation, peripheral arterial oxygenation, respiratory status, and administered fraction of inspired oxygen during the first 10 minutes of life in premature infants receiving umbilical cord milking compared with delayed cord clamping (DCC). STUDY DESIGN: Premature infants born at 230/7 to 276/7 weeks of gestation were randomized to umbilical cord milking or DCC. A near infrared spectroscopy sensor, pulse oximeter, and electrocardiogram electrodes were placed. Pulse rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and fraction of inspired oxygen were collected for 10 minutes in the delivery room. Longitudinal models were used to compare effects of umbilical cord milking and DCC. RESULTS: Fifty-six infants had cerebral oximetry and advanced monitoring at birth. There was an increased incidence of severe intraventricular hemorrhage in infants who received umbilical cord milking compared with DCC (P = .0211). Longitudinal models suggested that peripheral oxygen saturation was higher in the umbilical cord milking group in the first 4 minutes (P = .0221) and that mean airway pressures were lower in the umbilical cord milking group after the first 7 minutes (P = .0072). No statistical differences were observed for fraction of inspired oxygen, cerebral tissue oxygenation, or heart rates. CONCLUSIONS: The data suggest that the rapid transfer of blood during umbilical cord milking may facilitate lung expansion with improved pulmonary blood flow, but may also increase cerebral blood flow, resulting in severe intraventricular hemorrhage. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03145142.


Asunto(s)
Circulación Cerebrovascular , Parto Obstétrico/métodos , Hemodinámica/fisiología , Pulmón/irrigación sanguínea , Cordón Umbilical/irrigación sanguínea , Adulto , Hemorragia Cerebral Intraventricular/etiología , Parto Obstétrico/efectos adversos , Femenino , Humanos , Recien Nacido Extremadamente Prematuro , Recién Nacido , Embarazo , Resultado del Embarazo/epidemiología , Espectroscopía Infrarroja Corta , Factores de Tiempo
20.
Acta Paediatr ; 109(9): 1831-1837, 2020 09.
Artículo en Inglés | MEDLINE | ID: mdl-32053243

RESUMEN

AIM: Our aim was to examine the relationship between rescuers' anthropometric data and chest compression quality during paediatric resuscitation training. METHODS: This study focused on 224 medical students (53% women) who performed 2 minutes of paediatric resuscitation at the Medical University of Vienna, Austria: 116 on a baby manikin and 108 on an adolescent manikin. Skill Reporter software measured chest compression quality by recording compression depth, frequency, hand position and complete recoil. The participants' height, weight and body mass index (BMI) were recorded. RESULTS: Participants with a lower BMI achieved higher total chest compression scores on both the baby and adolescent manikins than participants with a higher BMI. The latter were more likely to exceed the correct compression depth and not achieve complete chest recoil in the adolescent manikin. When it came to the baby manikin, the female participants achieved better chest recoil and the males achieved a higher number of compressions at the correct rate. Males also achieved better chest recoil with the adolescent manikins. Being tall only correlated with incomplete recoil in the adolescent manikin. CONCLUSION: The results indicate that anthropometric variables were associated with chest compression quality in paediatric patients and should be considered by future education programmes.


Asunto(s)
Reanimación Cardiopulmonar , Adolescente , Austria , Peso Corporal , Niño , Femenino , Humanos , Masculino , Maniquíes , Presión
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