Ventilatory Assistance Before Umbilical Cord Clamping in Extremely Preterm Infants: A Randomized Clinical Trial.

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.

Considerations on the Use of Neonatal and Pediatric Resuscitation Guidelines for Hospitalized Neonates and Infants: On Behalf of the American Heart Association Emergency Cardiovascular Care Committee and the American Academy of Pediatrics.

Between 0.25% and 3% of admissions to the NICU, PICU, and PCICU receive cardiopulmonary resuscitation (CPR). Most CPR events occur in patients <1 year old. The incidence of CPR is 10 times higher in the NICU than at birth. Therefore, optimizing the approach to CPR in hospitalized neonates and infants is important. At birth, the resuscitation of newborns is performed according to neonatal resuscitation guidelines. In older infants and children, resuscitation is performed according to pediatric resuscitation guidelines. Neonatal and pediatric guidelines differ in several important ways. There are no published recommendations to guide the transition from neonatal to pediatric guidelines. Therefore, hospitalized neonates and infants can be resuscitated using neonatal guidelines, pediatric guidelines, or a hybrid approach. This report summarizes the current neonatal and pediatric resuscitation guidelines, considers how to apply them to hospitalized neonates and infants, and identifies knowledge gaps and future priorities. The lack of strong scientific data makes it impossible to provide definitive recommendations on when to transition from neonatal to pediatric resuscitation guidelines. Therefore, it is up to health care teams and institutions to decide if neonatal or pediatric guidelines are the best choice in a given location or situation, considering local circumstances, health care team preferences, and resource limitations.

Procedural training in neonatology.

PURPOSE OF REVIEW: To discuss a structured training process that can be used to guide curricula development in procedural skills in neonatal perinatal medicine training programs. RECENT FINDINGS: Achieving proficiency in life savings skills such as neonatal endotracheal intubation does not occur for all graduates of neonatal perinatal medicine programs. Innovations in procedural skills training offer opportunities to enhance the current educational environment and improve competency at all levels of learning. SUMMARY: A deliberate process of planning for procedural skills training and assessment of training outcomes is essential to ensure competence among graduates and practicing clinicians.

Primary Intensivists and Nurses for Long-Stay Patients: A Survey of Practices and Perceptions at Academic PICUs.

OBJECTIVES: To determine the prevalence of the utilization of primary intensivists and primary nurses for long-stay patients in large, academic PICU and ascertain how these practices are operationalized and perceived. DESIGN: A cross-sectional survey. SETTING: U.S. PICUs with accredited Pediatric Critical Care Medicine fellowships. SUBJECTS: One senior physician and one senior nurse at each institution. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: Separate but largely analogous questionnaires for intensivists and nurses were created using an iterative process to enhance content/face validity and readability. Sixty-seven intensivists (representing 93% of the 72 institutions with fellowship programs and their PICUs) and 59 nurses (representing 82%) responded. Twenty-four institutions utilize primary intensivists; 30 utilize primary nurses; and 13 utilize both. Most institutions use length of stay and/or other criteria (e.g., medical complexity) for eligibility. Commonly, not all patients that meet eligibility criteria receive primaries. Primary providers are overwhelmingly volunteers, and often only a fraction of providers participate. Primary intensivists at a large majority (>75%) of institutions facilitate information sharing and decision-making, attend family/team meetings, visit patients/families regularly, and are otherwise available upon request. Primary nurses at a similar majority of institutions provide consistent bedside care, facilitate information sharing, and attend family/team meetings. A large majority of respondents thought that primary intensivists increase patient/family satisfaction, reduce their stress, improve provider communication, and reduce conflict, whereas primary nurses similarly increase patient/family satisfaction. More than half of respondents shared that these practices can sometimes require effort (e.g., time and emotion), complicate decision-making, and/or reduce staffing flexibility. CONCLUSIONS: Primary practices are potential strategies to augment rotating PICU care models and better serve the needs of long-stay and other patients. These practices are being utilized to varying extents and with some operationalization uniformity at large, academic PICUs.

Continuous positive airway pressure for term and ≥34+0 weeks' gestation newborns at birth: A systematic review.

Background: Respiratory distress is common during transition after birth, but the effect of continuous positive airway pressure applied in the delivery room has not been systematically evaluated in spontaneously breathing term and ≥34+0 weeks' gestation infants.We aimed to compare delivery room continuous positive airway pressure with no delivery room continuous positive airway pressure for term and ≥34+0 weeks' gestation newborn infants at birth. Methods: Information sources: Medline, Embase, Cochrane Databases, Database of Abstracts of Reviews of Effects, and Cumulative Index to Nursing and Allied Health Literature. The Databases were last searched in October 2021.Eligibility criteria: Randomized, quasi-randomized, interrupted time series, controlled before-after, and cohort studies with English abstracts.Synthesis of results: Two authors independently extracted data, assessed risk of bias, and certainty of evidence. The main outcome was admission to the neonatal intensive care unit (NICU) or higher level of care receiving any positive pressure support. Data were pooled using fixed effects models.Risk of bias: Was assessed using the Cochrane Risk of Bias Tool for randomized trials and the Non-Randomized Studies of Interventions Tool (ROBINS-I) for observational studies. Results: In this meta-analysis, two randomized control trials (323 newborns delivered by cesarean section) showed that delivery room continuous positive airway pressure decreased the likelihood of NICU admission (risk ratio (RR) 95% confidence interval (CI) 0.27 (0.11-0.66), p < 0.005) and NICU respiratory support (RR (95% CI) 0.18 (0.05-0.60), p = 0.005) when compared with no delivery room continuous positive airway pressure. However, in two before-after studies (8,476 newborns), delivery room continuous positive airway pressure use was associated with an increased risk of air leak syndrome when compared with no delivery room continuous positive airway pressure. Discussion: Certainty of evidence was very low for all outcomes. Among term and ≥34+0 weeks' gestation infants having or at risk of having respiratory distress, there is insufficient evidence to suggest for or against routine use of continuous positive airway pressure in the delivery room.Funding: No Funding has been received to conduct this study.Clinical Trial Registration: This systematic review has been registered with the International Prospective Register of Systematic Reviews (http://www.crd.york.ac.uk/prospero/) [identifier: CRD42021225812].

Resuscitation 2020: Proceedings From the NeoHeart 2020 International Conference.

Resuscitation guidelines are developed and revised by medical societies throughout the world. These guidelines are increasingly based on evidence from preclinical and clinical research. The International Liaison Committee on Resuscitation reviews evidence for each resuscitation practice and provides summary consensus statements that inform resuscitation guideline committees. A similar process is used for different populations including neonatal, pediatric, and adult resuscitation. The NeoHeart 2020 Conference brought together experts in resuscitation to discuss recent evidence and guidelines for resuscitation practices. This review summarizes the main focus of discussion from this symposium.

The Term Newborn: Delivery Room Triage and Transitions of Care.

Term newborn infants without significant medical problems usually transition from fetal to newborn life without medical assistance. Infants requiring therapy often need care in a neonatal intensive care unit as opposed to a well-baby unit. Infants with unclear physiologic status or disease that may require therapies in the immediate newborn period may benefit from a period of observation with close monitoring before admission to a well-baby unit. Whenever possible, providing care for a newborn infant in an area that provides care for the newborn and mother together in the same room facilitates adaptation to normal breastfeeding and family bonding.

Evaluation of Ventricle Size Measurements in Infants by Pediatric Emergency Medicine Physicians.

OBJECTIVES: The identification of hydrocephalus in infants by pediatric emergency medicine (PEM) physicians using cranial point-of-care ultrasound (POCUS) has not been evaluated. We aimed to conduct a pilot/proof-of-concept study to evaluate whether PEM physicians can identify hydrocephalus (anterior horn width >5 mm) in 15 infants (mean 69 ± 42 days old) from the neonatal intensive care unit using POCUS. Our exploratory aims were to determine the test characteristics of cranial POCUS performed by PEM physicians for diagnosing hydrocephalus and the interrater reliability between measurements made by the PEM physicians and the radiologist. METHODS: Depending on the availability, 1 or 2 PEM physicians performed a cranial POCUS through the open anterior fontanel for each infant after a 30-minute didactic lecture to determine the size of the left and right ventricles by measuring the anterior horn width at the foramen of Monroe in coronal view. Within 1 week, an ultrasound (US) technologist performed a cranial US and a radiologist determined the ventricle sizes from the US images; these measurements were the criterion standard. RESULTS: A radiologist determined 12 of the 30 ventricles as hydrocephalic. The sensitivity and specificity of the PEM physicians performed cranial POCUS was 66.7% (95% confidence interval [CI], 34.9%-90.1%) and 94.4% (95% CI, 72.7%-99.9%), whereas the positive and negative predictive values were 88.9% (95% CI, 53.3%-98.2%) and 81.0% (95% CI, 65.5%-90.5%), respectively. The interrater reliability between the PEM physician's and radiologist's measurements was r = 0.91. The entire POCUS examinations performed by the PEM physicians took an average of 1.5 minutes. The time between the cranial POCUS and the radiology US was, on average, 4 days. CONCLUSIONS: While the PEM physicians in our study were able to determine the absence of hydrocephalus in infants with high specificity using cranial POCUS, there was insufficient evidence to support the use of this modality for identifying hydrocephalus. Future studies with more participants are warranted to accurately determine test characteristics.

Using video to assess and improve patient safety during simulated and actual neonatal resuscitation.

Neonatal resuscitation is an event that can cause high stress among healthcare professionals (HCPs) and is frequently associated with medical errors. Improving patient safety and reducing errors requires a concerted effort with a plan for improvement. Video can be used as a component of the improvement process at several points including standardizing educational information, assessing learner knowledge and skills during simulation, and assessing individual and team performance during actual neonatal resuscitations.

Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial.

OBJECTIVE: To determine if preterm infants with moderate respiratory distress syndrome on continuous positive airway pressure (CPAP) who received surfactant via a laryngeal mask airway (LMA) would have a decreased rate of intubation and mechanical ventilation compared with those on CPAP who did not receive surfactant. STUDY DESIGN: In this prospective, multicenter, randomized controlled trial, 103 premature infants 280/7-356/7 weeks gestation, ≥1250 g and ≤36 hours old on CPAP requiring fraction of inspired oxygen 0.30-0.40 were assigned to receive surfactant administered through an LMA then placed back on CPAP (LMA group) or maintained on CPAP with no surfactant administered (control group). The primary outcome was treatment failure necessitating intubation and mechanical ventilation in the first 7 days of life. RESULTS: Surfactant administration through an LMA (n = 50) significantly decreased the rate of intubation and mechanical ventilation compared with controls (n = 53): 38% vs 64%, respectively, OR 0.30 (95% CI 0.13, 0.70), P = .006, number needed to treat: 4). There were no serious adverse events associated with placement of the LMA or surfactant administration. CONCLUSIONS: In premature neonates with moderate respiratory distress syndrome, surfactant administered through an LMA decreased the rate of intubation and mechanical ventilation. This intervention may have significant impact on clinical care in both high and low resource settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01116921.

Intubation Attempts Increase the Risk for Severe Intraventricular Hemorrhage in Preterm Infants-A Retrospective Cohort Study.

OBJECTIVE: To evaluate whether neonates exposed to multiple intubation attempts within the first 4 days after birth have an increased incidence of intraventricular hemorrhage (IVH). STUDY DESIGN: This is a retrospective cohort study of infants intubated during the first 4 days after birth. Infants had birth weights (BWs) less than 1500 g and were admitted to the neonatal intensive care unit (NICU) at the University of California, San Diego, between January 1, 2005, and July 30, 2009. A subgroup analysis was done for infants with BW less than 750 g. RESULTS: A total of 308 infants with BW <1500 g, including 102 with a BW <750 g, were intubated within the first 4 days of life. The number of intubation attempts was significantly greater in infants with a BW <750 g who had severe IVH compared with those with mild or no IVH (OR 1.395, 95% CI 1.090-1.786, P = .008). For infants with BW <1500 g, the number of intubation attempts in the delivery room was significantly greater for infants with severe IVH (OR 1.317, 95% CI 1.052-1.649, P = .016). CONCLUSION: Increased intubation attempts were associated with increased incidence of severe IVH in infants with BW less than 750 g and in infants less than 1500 g who were intubated only in the delivery room. Prospective studies are needed to further evaluate the relationship between intubation attempts and severe IVH.

The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates.

OBJECTIVE: To determine whether umbilical cord milking (UCM) improves systemic blood flow and reduces neonatal morbidities compared with immediate cord clamping (ICC). STUDY DESIGN: Women admitted to a tertiary care center and delivering before 32 weeks' gestation were randomized to receive UCM or ICC. Three blinded serial echocardiograms were performed in the first 2 days of the infant's life. The primary outcome was measured systemic blood flow (superior vena cava flow) at each time point. RESULTS: Of the 60 neonates who were enrolled and randomized, 30 were assigned to cord milking and 30 to ICC. Neonates randomized to cord milking had greater measures of superior vena cava flow and right ventricular output in the first 6 hours and 30 hours of life. Neonates receiving UCM also had greater serum hemoglobin, received fewer blood transfusions, fewer days on oxygen therapy, and less frequent use of oxygen at 36 weeks' corrected postmenstrual age. CONCLUSIONS: We demonstrate greater systemic blood flow with UCM in preterm neonates compared with ICC. Future large prospective trials are needed to determine whether UCM reduces intraventricular hemorrhage and other long-term morbidities.

Quantitative end-tidal carbon dioxide monitoring in the delivery room: a randomized controlled trial.

OBJECTIVES: To investigate the utility of continuous quantitative end-tidal CO2 (Etco2) monitoring for managing assisted ventilation in the delivery room (DR). STUDY DESIGN: This is a prospective randomized controlled trial. Infants who received positive pressure ventilation (PPV) were randomized to a control versus a monitored arm. In the monitored arm, the resuscitating team adjusted PPV based on Etco2 values. In the control arm, the team provided PPV based on clinical assessment. Etco2 levels after resuscitation and admission Pco2 levels were compared between groups. RESULTS: Fifty infants were enrolled, and 48 subjects had primary outcome data. Of those, 7 infants were intubated in the DR, 41 infants received PPV via mask until respiratory support could be maintained on continuous positive airway pressure alone. The median Etco2 levels at the end of resuscitation were 44 mm Hg (16-66 mm Hg) in the control arm and 43 mm Hg (29-59 mm Hg) in the monitored arm. The proportion of Etco2 levels outside of the prespecified range was 52.6% (control) and 33.3% (monitored) (P = .236). The median admission Pco2 levels were 57 mm Hg (36-110 mm Hg) in the control arm and 55 mm Hg (40-93 mm Hg) in the monitored arm. The proportion of admission Pco2 levels outside of the prespecified range was 33.3% (control) versus 37.5% (monitored) (P = .763). CONCLUSIONS: Etco2 monitoring in the DR did not reduce the proportion of admission Pco2 levels outside of the prespecified range in a population of infants supported mostly with noninvasive ventilation.

The delivery room of the future: the fetal and neonatal resuscitation and transition suite.

Despite advances in the understanding of fetal and neonatal physiology and the technology to monitor and treat premature and full-term neonates, little has changed in resuscitation rooms. The authors' vision for the Fetal and Neonatal Resuscitation and Transition Suite of the future is marked by improvements in the amount of physical space, monitoring technologies, portable diagnostic and therapeutic technologies, communication systems, and capabilities and training of the resuscitation team. Human factors analysis will play an important role in the design and testing of the improvements for safe, effective, and efficient resuscitation of the newborn.

Delivery room respiratory management of the term and preterm infant.

The immediate newborn transition is a time of great physiologic adjustments and many infants need assistance to make a successful transition to newborn life. Assisted ventilation is the most important intervention performed during this transitional period. Noninvasive ventilation is a necessary skill for all pediatric providers because it is the most frequently required lifesaving measure provided in the delivery room. Providing ventilation in the least injurious manner is also necessary and many aspects of how this can best be done are still unknown. Following the normal physiology of fetal to neonatal transition continues to be a logical, but challenging, approach to initial ventilatory support of the newborn in the delivery room.

Shock: a common consequence of neonatal asphyxia.

Neonatal asphyxia is associated with multi-organ hypoxia-ischemia and subsequent dysfunction. The cardiovascular system is frequently affected, causing signs of shock and complicating the neonatal circulatory transition. Hypothermia therapy can improve outcome from neonatal asphyxia without adversely affecting cardiovascular stability. Therapy directed at the cardiovascular system can improve short-term measures of systemic blood flow, but to date has not been demonstrated to improve long-term outcome.

Resuscitation of preterm neonates by using room air or 100% oxygen.

OBJECTIVE: In this study of preterm neonates of <32 weeks, we prospectively compared the use of room air versus 100% oxygen as the initial resuscitation gas. METHODS: A 2-center, prospective, randomized, controlled trial of neonates with gestational ages of 23 to 32 weeks who required resuscitation was performed. The oxygen group was initially resuscitated with 100% oxygen, with decreases in the fraction of inspired oxygen after 5 minutes of life if pulse oxygen saturation was >95%. The room air group was initially resuscitated with 21% oxygen, which was increased to 100% oxygen if compressions were performed or if the heart rate was <100 beats per minute at 2 minutes of life. Oxygen was increased in 25% increments if pulse oxygen saturation was <70% at 3 minutes of life or <80% at 5 minutes of life. RESULTS: Twenty-three infants in the oxygen group (mean gestational age: 27.6 weeks; range: 24-31 weeks; mean birth weight: 1013 g; range: 495-2309 g) and 18 in the room air group (mean gestational age: 28 weeks; range: 25-31 weeks; mean birth weight: 1091 g; range: 555-1840 g) were evaluated. Every resuscitated patient in the room air group met rescue criteria and received an increase in the fraction of inspired oxygen by 3 minutes of life, 6 patients directly to 100% and 12 with incremental increases. Pulse oxygen saturation was significantly lower in the room air group from 2 to 10 minutes (pulse oxygen saturation at 3 minutes: 55% in the room air group vs 87% in the oxygen group). Heart rates did not differ between groups in the first 10 minutes of life, and there were no differences in secondary outcomes. CONCLUSIONS: Resuscitation with room air failed to achieve our target oxygen saturation by 3 minutes of life, and we recommend that it not be used for preterm neonates.

Premedication for nonemergent neonatal intubations: a randomized, controlled trial comparing atropine and fentanyl to atropine, fentanyl, and mivacurium.

OBJECTIVE: The purpose of this work was to investigate whether using a muscle relaxant would improve intubation conditions in infants, thereby decreasing the incidence and duration of hypoxia and time and number of attempts needed to successfully complete the intubation procedure. PATIENTS/METHODS: This was a prospective, randomized, controlled, 2-center trial. Infants requiring nonemergent intubation were randomly assigned to receive atropine and fentanyl or atropine, fentanyl, and mivacurium before intubation. Incidence and duration of hypoxia were determined at oxygen saturation thresholds of < or = 85%, < or = 75%, < or = 60%, and < or = 40%. Videotape was reviewed to determine the time and number of intubation attempts and duration of action of mivacurium. RESULTS: Analysis of 41 infants showed that incidence of oxygen saturation < or = 60% of any duration was significantly less in the mivacurium group (55% vs 24%). The incidence of saturation level of any duration < or = 85%, 75%, and 40%; cumulative time > or = 30 seconds; and time below the thresholds were not significantly different. Total procedure time (472 vs 144 seconds) and total laryngoscope time (148 vs 61 seconds) were shorter in the mivacurium group. Successful intubation was achieved in < or = 2 attempts significantly more often in the mivacurium group (35% vs 71%). CONCLUSIONS: Premedication with atropine, fentanyl, and mivacurium compared with atropine and fentanyl without a muscle relaxant decreases the time and number of attempts needed to successfully intubate while significantly reducing the incidence of severe desaturation. Premedication including a short-acting muscle relaxant should be considered for all nonemergent intubations in the NICU.

Disposable colorimetric carbon dioxide detector use as an indicator of a patent airway during noninvasive mask ventilation.

Colorimetric carbon dioxide detectors are useful indicators of proper endotracheal tube placement. We have found that they also are helpful during bag and mask ventilation as an indicator of a patent airway. In this report, we describe our experience with these devices for use during preintubation airway stabilization as observed during videotaped performances from a prospective, randomized trial of intubation premedication.