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.

2023 American Heart Association and American Academy of Pediatrics Focused Update on Neonatal Resuscitation: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.

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.

2023 American Heart Association and American Academy of Pediatrics Focused Update on Neonatal Resuscitation: An Update to the American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care.

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.

Cardiopulmonary resuscitation in low-resource settings: a statement by the International Liaison Committee on Resuscitation, supported by the AFEM, EUSEM, IFEM, and IFRC.

Most recommendations on cardiopulmonary resuscitation were developed from the perspective of high-resource settings with the aim of applying them in these settings. These so-called international guidelines are often not applicable in low-resource settings. Organisations including the International Liaison Committee on Resuscitation (ILCOR) have not sufficiently addressed this problem. We formed a collaborative group of experts from various settings including low-income, middle-income, and high-income countries, and conducted a prospective, multiphase consensus process to formulate this ILCOR Task Force statement. We highlight the discrepancy between current cardiopulmonary resuscitation guidelines and their applicability in low-resource settings. Successful existing initiatives such as the Helping Babies Breathe programme and the WHO Emergency Care Systems Framework are acknowledged. The concept of the chainmail of survival as an adaptive approach towards a framework of resuscitation, the potential enablers of and barriers to this framework, and gaps in the knowledge are discussed, focusing on low-resource settings. Action points are proposed, which might be expanded into future recommendations and suggestions, addressing a large diversity of addressees from caregivers to stakeholders. This statement serves as a stepping-stone to developing a truly global approach to guide resuscitation care and science, including in health-care systems worldwide.

Impact of State Prioritization of Safe Infant Sleep Programs on Supine Sleep Positioning for Non-Hispanic White and Non-Hispanic Black Infants.

OBJECTIVE: Investigate whether safe infant sleep prioritization by states through the Title V Maternal and Child Block Grant in 2010 differentially impacted maternal report of supine sleep positioning (SSP) for Non-Hispanic White (NHW) and Non-Hispanic Black (NHB) U.S.-born infants. STUDY DESIGN: We analyzed retrospective cross-sectional data from the Pregnancy Risk Assessment Monitoring System (PRAMS) from 2005 to 2015 from 4 states: WV and OK (Intervention) and AR and UT (Control). PRAMS is a population-based surveillance system of maternal perinatal experiences which is linked to infant birth certificates. Piece-wise survey linear regression models were used to estimate the difference in the change in slopes of SSP percents in the pre- (2005-2009) and post- (2011-2015) periods, controlling for maternal and infant characteristics. Models were also stratified by race/ethnicity. RESULTS: From 2005 to 2015, for NHW infants, SSP improved from 61.5% and 70.2% to 82.8% and 82.3% for intervention and control states, respectively. For NHB infants, SSP improved from 30.6% and 26.5% to 64.5% and 53.1% for intervention and control states, respectively. After adjustment for maternal characteristics, there was no difference in the rate of SSP change from the pre- to post- intervention periods for either NHW or NHB infants in intervention or control groups. CONCLUSION: Compared with control states that did not prioritize safe infant sleep in their 2010 Title V Block Grant needs assessment, intervention states experienced no difference in SSP improvement rates for NHW and NHB infants. While SSP increased for all infants during the study period, there was no causal relationship between states' prioritization of safe infant sleep and SSP improvement. More targeted approaches may be needed to reduce the racial/ethnic disparity in SSP and reduce the risk for sleep-associated infant death. KEY POINTS: · Supine sleep positioning improved for Black and White infants in the U.S.. · State prioritization of safe infant sleep did not directly impact SSP for NHB or NHW infants.. · More targeted approaches may be needed to reduce racial/ethnic disparities in safe sleep practices.

Increased risk of bradycardia in vigorous infants receiving early as compared to delayed cord clamping at birth.

OBJECTIVE: To compare HR pattern of vigorous newborns during the first 180 s with early (≤60 s, ECC) or delayed (>60 s, DCC) cord clamping. STUDY DESIGN: Observational study including dry-electrode ECG monitoring of 610 vaginally-born singleton term and late-preterm (≥34 weeks) who were vigorous after birth. RESULTS: 198 received ECC while 412 received DCC with median cord clamping at 37 s and 94 s. Median HR remained stable from 30 to 180 s with DCC (172 and 170 bpm respectively) but increased with ECC (169 and 184 bpm). The proportion with bradycardia was higher among ECC than DCC at 30 s and fell faster in the DCC through 60 s. After adjusting for factors affecting timing of cord clamping, ECC had significant risk of bradycardia compared to DCC (aRR 1.51; 95% CI; 1.01-2.26). CONCLUSION: Early heart instability and higher risk of bradycardia with ECC as compared to DCC supports the recommended clinical practice of DCC.

Neonatal resuscitation from a global perspective.

The majority of perinatal and neonatal mortality occurs in low-resource settings in low- and middle-income countries. Access and quality of care at delivery are major determinants of the health and survival of newborn infants. Availability of basic neonatal resuscitation care at birth has improved, but basic neonatal resuscitation at birth or high-quality care continues to be inaccessible in some settings, leading to persistently high perinatal and neonatal mortality. Low-resource settings of high-income countries and socially disadvantaged communities also suffer from inadequate access to quality perinatal healthcare. Quality improvement, implementation research, and innovation should focus on improving the quality of perinatal healthcare and perinatal and neonatal outcomes in low-resource settings. The current review presents an update on issues confronting universal availability of optimal resuscitation care at birth and provides an update on ongoing efforts to address them.

Toward greater nuance in delayed cord clamping.

PURPOSE OF REVIEW: For over a decade, the International Liaison Committee on Resuscitation has recommended delayed cord clamping (DCC), but implementation has been variable due to lack of consensus on details of technique and concerns for risks in certain patient populations. This review summarizes recent literature on the benefits and risks of DCC in term and preterm infants and examines alternative approaches such as physiologic-based cord clamping or intact cord resuscitation (ICR) and umbilical cord milking (UCM). RECENT FINDINGS: DCC improves hemoglobin/hematocrit among term infants and may promote improved neurodevelopment. In preterms, DCC improves survival compared to early cord clamping; however, UCM has been associated with severe intraventricular hemorrhage in extremely preterm infants. Infants of COVID-19 positive mothers, growth-restricted babies, multiples, and some infants with cardiopulmonary anomalies can also benefit from DCC. Large randomized trials of ICR will clarify safety and benefits in nonvigorous neonates. These have the potential to dramatically change the sequence of events during neonatal resuscitation. SUMMARY: Umbilical cord management has moved beyond simple time-based comparisons to nuances of technique and application in vulnerable sub-populations. Ongoing research highlights the importance of an individualized approach that recognizes the physiologic equilibrium when ventilation is established before cord clamping.

Impact of stimulation among non-crying neonates with intact cord versus clamped cord on birth outcomes: observation study.

Background: Stimulation of non-crying neonates after birth can help transition to spontaneous breathing. In this study, we aim to assess the impact of intact versus clamped umbilical cord on spontaneous breathing after stimulation of non-crying neonates. Methods: This is an observational study among non-crying neonates (n=3073) born in hospitals of Nepal. Non-crying neonates born vaginally at gestational age ≥34 weeks were observed for their response to stimulation with the cord intact or clamped. Obstetric characteristics of the neonates were analysed. Association of spontaneous breathing with cord management was assessed using logistic regression. Results: Among non-crying neonates, 2563 received stimulation. Of these, a higher proportion of the neonates were breathing in the group with cord intact as compared with the group cord clamped (81.1% vs 68.9%, p<0.0001). The use of bag-and-mask ventilation was lower among those who were stimulated with the cord intact than those who were stimulated with cord clamped (18.0% vs 32.4%, p<0.0001). The proportion of neonates with Apgar Score ≤3 at 1 min was lower with the cord intact than with cord clamped (7.6% vs 11.5%, p=0.001). In multivariate analysis, neonates with intact cord had 84% increased odds of spontaneous breathing (adjusted OR, 1.84; 95% CI: 1.48 to 2.29) compared with those with cord clamped. Conclusions: Stimulation of non-crying neonates with intact cord was associated with more spontaneous breathing than among infants who were stimulated with cord clamped. Intact cord stimulation may help establish spontaneous breathing in apnoeic neonates, but residual confounding variables may be contributing to the findings. This study provides evidence for further controlled research to evaluate the effect of initial steps of resuscitation with cord intact.

Persistent Racial/Ethnic Disparities in Supine Sleep Positioning among US Preterm Infants, 2000-2015.

OBJECTIVE: To assess trends in racial disparity in supine sleep positioning (SSP) across racial/ethnic groups of infants born early preterm (Early preterm; <34 weeks) and late preterm (Late preterm; 34-36 weeks) from 2000 to 2015. STUDY DESIGN: We analyzed Pregnancy Risk Assessment Monitoring System data (a population-based perinatal surveillance system) from 16 US states from 2000 to 2015 (Weighted N = 1 020 986). Marginal prevalence of SSP by year was estimated for infants who were early preterm and late preterm, adjusting for maternal and infant characteristics. After stratifying infants who were early preterm and late preterm, we compared the aOR of SSP trends across racial/ethnic groups by testing the time-race interaction. RESULTS: From 2000 to 2015, Non-Hispanic Black infants had lower odds of SSP compared with Non-Hispanic White infants for early preterm (aOR 0.61; 95% CI 0.47-0.78) and late preterm (aOR 0.44; 95% CI 0.34-0.56) groups. For Hispanic infants, there was no statistically significant difference for either preterm group when compared with Non-Hispanic White infants. aOR of SSP increased (on average) annually by 10.0%, 7.3%, and 7.7%, respectively, in Non-Hispanic White, Non-Hispanic Black, and Hispanic early preterm infants and by 5.8%, 5.9%, and 4.8% among Non-Hispanic White, Non-Hispanic Black, and Hispanic late preterm infants. However, there were no significant between-group differences in annual changes (Early preterm: P = .11; Late preterm: P = .25). CONCLUSIONS: SSP increased for all racial/ethnic preterm groups from 2000 to 2015. However, the racial/ethnic disparity in SSP among early preterm and late preterm groups persists.

Neonatal resuscitation: EN-BIRTH multi-country validation study.

BACKGROUND: Annually, 14 million newborns require stimulation to initiate breathing at birth and 6 million require bag-mask-ventilation (BMV). Many countries have invested in facility-based neonatal resuscitation equipment and training. However, there is no consistent tracking for neonatal resuscitation coverage. METHODS: The EN-BIRTH study, in five hospitals in Bangladesh, Nepal, and Tanzania (2017-2018), collected time-stamped data for care around birth, including neonatal resuscitation. Researchers surveyed women and extracted data from routine labour ward registers. To assess accuracy, we compared gold standard observed coverage to survey-reported and register-recorded coverage, using absolute difference, validity ratios, and individual-level validation metrics (sensitivity, specificity, percent agreement). We analysed two resuscitation numerators (stimulation, BMV) and three denominators (live births and fresh stillbirths, non-crying, non-breathing). We also examined timeliness of BMV. Qualitative data were collected from health workers and data collectors regarding barriers and enablers to routine recording of resuscitation. RESULTS: Among 22,752 observed births, 5330 (23.4%) babies did not cry and 3860 (17.0%) did not breathe in the first minute after birth. 16.2% (n = 3688) of babies were stimulated and 4.4% (n = 998) received BMV. Survey-report underestimated coverage of stimulation and BMV. Four of five labour ward registers captured resuscitation numerators. Stimulation had variable accuracy (sensitivity 7.5-40.8%, specificity 66.8-99.5%), BMV accuracy was higher (sensitivity 12.4-48.4%, specificity > 93%), with small absolute differences between observed and recorded BMV. Accuracy did not vary by denominator option. < 1% of BMV was initiated within 1 min of birth. Enablers to register recording included training and data use while barriers included register design, documentation burden, and time pressure. CONCLUSIONS: Population-based surveys are unlikely to be useful for measuring resuscitation coverage given low validity of exit-survey report. Routine labour ward registers have potential to accurately capture BMV as the numerator. Measuring the true denominator for clinical need is complex; newborns may require BMV if breathing ineffectively or experiencing apnoea after initial drying/stimulation or subsequently at any time. Further denominator research is required to evaluate non-crying as a potential alternative in the context of respectful care. Measuring quality gaps, notably timely provision of resuscitation, is crucial for programme improvement and impact, but unlikely to be feasible in routine systems, requiring audits and special studies.

Umbilical Cord Management at Term and Late Preterm Birth: A Meta-analysis.

CONTEXT: The International Liaison Committee on Resuscitation prioritized scientific review of umbilical cord management at term and late preterm birth. OBJECTIVE: To assess effects of umbilical cord management strategies (clamping timing and cord milking) in infants ≥34 weeks' gestational age. DATA SOURCES: Cochrane Central Register of Controlled Trials, Medline, PubMed, Embase, Cumulative Index to Nursing and Allied Health Literature, and trial registries searched July 2019. STUDY SELECTION: Two authors independently assessed eligibility of randomized controlled trials. DATA EXTRACTION: Two authors independently extracted data and assessed evidence certainty (Grading of Recommendations Assessment, Development and Evaluations). RESULTS: We identified 46 studies (9159 women and their infants) investigating 7 comparisons. Compared with early cord clamping (ECC) <30 seconds, delayed cord clamping (DCC) ≥30 seconds (33 studies), intact-cord milking (1 study), and cut-cord milking (2 studies) probably improve hematologic measures but may not affect survival without neurodisability, anemia in early infancy, or maternal postpartum hemorrhage. No differences in major neonatal morbidities are seen in studies comparing methods of optimizing placental transfusion (DCC versus cut-cord milking [3 studies], longer delays in clamping [7 studies], or physiologic parameters [3 studies]). Strategies that promote increased placental transfusion may be associated with greater phototherapy use. Evidence for all outcomes was low or very low certainty. LIMITATIONS: Incompleteness and low certainty of findings limit applicability. CONCLUSIONS: Compared with ECC, DCC or cord milking increases hemoglobin and hematocrit immediately after birth in infants ≥34 weeks' gestational age. The uncertain effects of DCC and cord milking compared with ECC on major morbidities limit usefulness of available evidence for policy and practice.

A Short History of Helping Babies Breathe: Why and How, Then and Now.

Helping Babies Breathe (HBB) changed global education in neonatal resuscitation. Although rooted in the technical and educational expertise underpinning the American Academy of Pediatrics' Neonatal Resuscitation Program, a series of global collaborations and pivotal encounters shaped the program differently. An innovative neonatal simulator, graphic learning materials, and content tailored to address the major causes of neonatal death in low- and middle-income countries empowered providers to take action to help infants in their facilities. Strategic dissemination and implementation through a Global Development Alliance spread the program rapidly, but perhaps the greatest factor in its success was the enthusiasm of participants who experienced the power of being able to improve the outcome of babies. Collaboration continued with frontline users, implementing organizations, researchers, and global health leaders to improve the effectiveness of the program. The second edition of HBB not only incorporated new science but also the accumulated understanding of how to help providers retain and build skills and use quality improvement techniques. Although the implementation of HBB has resulted in significant decreases in fresh stillbirth and early neonatal mortality, the goal of having a skilled and equipped provider at every birth remains to be achieved. Continued collaboration and the leadership of empowered health care providers within their own countries will bring the world closer to this goal.

Helping Babies Breathe Global Development Alliance and the Power of Partnerships.

The Helping Babies Breathe Global Development Alliance (GDA) was a public-private partnership created simultaneously with the launch of the educational program Helping Babies Breathe to accelerate dissemination and implementation of neonatal resuscitation in low- and middle-income countries with the goal of reducing the global burden of neonatal mortality and morbidity related to birth asphyxia. Representatives from 6 organizations in the GDA highlight the recognized needs that motivated their participation and how they built on one another's strengths in resuscitation science and education, advocacy, frontline implementation, health system strengthening, and implementation research to achieve common goals. Contributions of time, talent, and financial resources from the community, government, and private corporations and foundations powered an initiative that transformed the landscape for neonatal resuscitation in low- and middle-income countries. The organizations describe the power of partnerships, the challenges they faced, and how each organization was shaped by the collaboration. Although great progress was achieved, lessons learned through the GDA and additional efforts must still be applied to the remaining challenges of prevention, widespread implementation, improvement in the quality of care, and sustainable integration of neonatal resuscitation and essential newborn care into the fabric of health care systems.