Two-Year Outcomes of Umbilical Cord Milking in Nonvigorous Infants: A Secondary Analysis of the MINVI Randomized Clinical Trial.

Importance: Compared with early cord clamping (ECC), umbilical cord milking (UCM) reduces delivery room cardiorespiratory support, hypoxic-ischemic encephalopathy, and therapeutic hypothermia in nonvigorous near-term and full-term infants. However, UCM postdischarge outcomes are not known. Objective: To determine the 2-year outcomes of children randomized to UCM or ECC at birth in the Milking in Nonvigorous Infants (MINVI) trial. Design, Setting, and Participants: A secondary analysis to evaluate longer-term outcomes of a cluster-randomized crossover trial was conducted from January 9, 2021, to September 25, 2023. The primary trial took place in 10 medical centers in the US, Canada, and Poland from January 5, 2019, to June 1, 2021, and hypothesized that UCM would reduce admission to the neonatal intensive care unit compared with ECC; follow-up concluded September 26, 2023. The population included near-term and full-term infants aged 35 to 42 weeks' gestation at birth who were nonvigorous; families provided consent to complete developmental screening questionnaires through age 2 years. Intervention: UCM and ECC. Main Outcomes and Measures: Ages and Stages Questionnaire, 3rd Edition (ASQ-3) and Modified Checklist for Autism in Toddlers, Revised/Follow-Up (M-CHAT-R/F) questionnaires at ages 22 to 26 months. Intention-to-treat analysis and per-protocol analyses were used. Results: Among 1730 newborns from the primary trial, long-term outcomes were evaluated in 971 children (81%) who had ASQ-3 scores available at 2 years or died before age 2 years and 927 children (77%) who had M-CHAT-R/F scores or died before age 2 years. Maternal and neonatal characteristics by treatment group were similar, with median birth gestational age of 39 (IQR, 38-40) weeks in both groups; 224 infants (45%) in the UCM group and 201 (43%) in the ECC group were female. The median ASQ-3 total scores were similar (UCM: 255 [IQR, 225-280] vs ECC: 255 [IQR, 230-280]; P = .87), with no significant differences in the ASQ-3 subdomains. Medium- to high-risk M-CHAT-R/F scores were also similar (UCM, 9% [45 of 486] vs ECC, 8% [37 of 441]; P = .86). Conclusions and Relevance: In this secondary analysis of a randomized clinical trial among late near-term and full-term infants who were nonvigorous at birth, ASQ-3 scores at age 2 years were not significantly different between the UCM and ECC groups. Combined with previously reported important short-term benefits, this follow-up study suggests UCM is a feasible, no-cost intervention without longer-term neurodevelopmental risks of cord milking in nonvigorous near-term and term newborns. Trial Registration: ClinicalTrials.gov Identifier: NCT03631940.

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.

Does the use of higher versus lower oxygen concentration improve neurodevelopmental outcomes at 18-24 months in very low birthweight infants?

BACKGROUND: Immediately after birth, the oxygen saturation is between 30 and 50%, which then increases to 85-95% within the first 10 min. Over the last 10 years, recommendations regarding the ideal level of the initial fraction of inspired oxygen (FiO2) for resuscitation in preterm infants have changed from 1.0, to room air to low levels of oxygen (< 0.3), up to moderate concentrations (0.3-0.65). This leaves clinicians in a challenging position, and a large multi-center international trial of sufficient sample size that is powered to look at safety outcomes such as mortality and adverse neurodevelopmental outcomes is required to provide the necessary evidence to guide clinical practice with confidence. METHODS: An international cluster, cross-over randomized trial of initial FiO2 of 0.3 or 0.6 during neonatal resuscitation in preterm infants at birth to increase survival free of major neurodevelopmental outcomes at 18 and 24 months corrected age will be conducted. Preterm infants born between 230/7 and 286/7 weeks' gestation will be eligible. Each participating hospital will be randomized to either an initial FiO2 concentration of either 0.3 or 0.6 to recruit for up to 12 months' and then crossed over to the other concentration for up to 12 months. The intervention will be initial FiO2 of 0.6, and the comparator will be initial FiO2 of 0.3 during respiratory support in the delivery room. The sample size will be 1200 preterm infants. This will yield 80% power, assuming a type 1 error of 5% to detect a 25% reduction in relative risk of the primary outcome from 35 to 26.5%. The primary outcome will be a composite of all-cause mortality or the presence of a major neurodevelopmental outcome between 18 and 24 months corrected age. Secondary outcomes will include the components of the primary outcome (death, cerebral palsy, major developmental delay involving cognition, speech, visual, or hearing impairment) in addition to neonatal morbidities (severe brain injury, bronchopulmonary dysplasia; and severe retinopathy of prematurity). DISCUSSION: The use of supplementary oxygen may be crucial but also potentially detrimental to preterm infants at birth. The HiLo trial is powered for the primary outcome and will address gaps in the evidence due to its pragmatic and inclusive design, targeting all extremely preterm infants. Should 60% initial oxygen concertation increase survival free of major neurodevelopmental outcomes at 18-24 months corrected age, without severe adverse effects, this readily available intervention could be introduced immediately into clinical practice. TRIAL REGISTRATION: The trial was registered on January 31, 2019, at ClinicalTrials.gov with the Identifier: NCT03825835.

Tracheostomies in term and preterm infants: A single-center Canadian retrospective cohort.

OBJECTIVE: To examine patient characteristics, hospital course, and medical outcomes of neonatal tracheostomy at a single center. DESIGN: Retrospective cohort study. SETTING: Level III neonatal intensive care units (NICUs) in Edmonton, Canada. PATIENTS: Infants admitted to NICU who underwent tracheostomy between January 2013 and December 2017 inclusive. MAIN OUTCOME MEASURES: Hospital course, discharge, and 3-year post-tracheostomy outcomes were compared between preterm infants <29 weeks gestation and infants with congenital anomalies. RESULTS: Forty-three infants were identified; seven were lost to follow-up and excluded. Of the 36 analyzed, 86% survived to discharge. At discharge, 13% were decannulated, 36% required no mechanical ventilation, and 52% required mechanical ventilation. Median hospitalization was 295 days. At 3 years post-tracheostomy, 97% were alive. Proportions of infants with tracheostomy in situ was 80%, 73%, and 60% at 1, 2, and 3 years post tracheostomy. Tracheostomy incidence was 2.7% for preterm infants <29 weeks gestational age with 55% for subglottic stenosis. All preterm infants received postnatal steroids. Preterm infants underwent tracheostomy at later chronological age (123 vs. 81 days, p < 0.001), but similar corrected gestational age (42 + 5 vs. 51 + 2 weeks, p = 0.095). Preterm infants had more intubation attempts (17 vs. 4, p < 0.001), total extubations (8 vs. 2, p < 0.001), and days on ventilation before tracheostomy (100 vs. 78, p < 0.001). CONCLUSIONS: Infants who underwent tracheostomy in a Canadian public healthcare setting demonstrated decreasing tracheostomy dependence and high survival post tracheostomy, despite prolonged hospitalization. Preterm infants had more intubation and extubation events which may have contributed to airway injury.

Using eye-tracking augmented cognitive task analysis to explore healthcare professionals' cognition during neonatal resuscitation.

AIM: We aimed to describe the cognitive processes of healthcare providers participating as airway leads in delivery room neonatal resuscitations using eye-tracking assisted debriefing to facilitate recall and provide situational context. METHODS: Delivery room neonatal resuscitations were recorded using eye-tracking glasses worn by participants who acted as airway leads. These glasses analyze eye-movements to produce an audio-visual recording approximating what was "seen" by the participant and marking their visual attention. Participants then reviewed and debriefed their recordings. Debriefing involved a retrospective think-aloud prompted by eye-tracked recordings and an integrated semi-structured interview. Debriefing sessions were transcribed and subjected to thematic analysis. RESULTS: Eight healthcare providers participated in 10 interviews; two providers participated twice in two separate resuscitations. Most visual attention was directed at the infant (62%), with 16% directed to monitors/gauges, 3% to team members. Five major themes emerged including situation awareness, performance, working in teams, addressing threats to performance, and perception of eye-tracking. Information processing was complex and involved top-down and bottom-up processing of environmental stimuli, integration of knowledge/experience, and anticipation of patient response. Despite the focus on individual cognition, interpersonal interactions and teamwork emerged as key aspects of resuscitation performance. Potential threats to performance include equipment issues, mental stress, distractions, and parental presence. Eye-tracking recordings were well-received by the participants. CONCLUSION: Retrospective think-aloud prompted by point-of-view eye-tracked recordings is a useful means of examining cognition of healthcare providers during neonatal resuscitation. Themes identified in this project aligned with existing models of clinical reasoning.

Assessment of Healthcare Provider Workload in Neonatal Resuscitation.

Objective: Human errors or protocol deviations during neonatal resuscitation are common. Excess workload has been proposed as a contributor to human error during medical tasks. We aim to characterize healthcare providers' perceived workload during neonatal resuscitation. Design: Perceived workload was measured using a multi-dimensional retrospective National Aeronautics and Space Administration Task Load Index (NASA TLX) survey. The NASA TLX collects data on mental, physical, and temporal demand, performance, effort, and frustration. Each section is rated independently by participants on a scale of 0-20 (0 being lowest and 20 being highest). The Raw-TLX score is a composite score of all dimensions and presented on a scale of 0-100. Healthcare providers complete a paper and pencil survey after attending delivery room resuscitations within 3 months. Setting: Level three neonatal intensive care unit at the Royal Alexandra Hospital, Edmonton, AB, Canada. Participants: All neonatal healthcare providers who attended deliveries. Exposure: Participation in the delivery room care of newborns. Measurement: Raw TLX scores as a measure of overall workload and scores for each dimension of workload. Main Results: During the study period, ~880 neonatal resuscitation events occurred, and a total of 204 surveys were completed. Healthcare providers completed one survey for 179 deliveries, two surveys for 20 deliveries, and three surveys for 5 deliveries. The mean (standard deviation) gestational age was 35 (5) weeks, and the median (interquartile range) birth weight was 2,690 (1,830-3,440) g. Interventions at delivery were (i) stimulation 149 (73%), suction 130 (64%), continuous positive airway pressure 120 (59%), positive pressure ventilation 105 (52%), intubation 33 (16%), chest compression 10 (5%), and epinephrine 4 (2%). The overall median (interquartile range) Raw-TLX was 34 (18-49). The scores varied by dimension with mental demand 10 (5-14), physical demand 4 (1-6), temporal demand 8 (3-14), performance 4 (2-6), effort 8 (4-13), and frustration 4 (1-10). Raw-TLX scores were higher when healthcare providers performed any intervention compared to no intervention [35 (22-49) vs. 8 (6-18), p = 0.0011]; intubation and no intubation was [55 (46-62) vs. 30 (17-46), p = 0.0001], and between performing chest compression vs. no chest compression [55 (49-64) vs. 33 (18-47), p = 0.001]. Conclusion: Perceived workload of neonatal healthcare providers increases during higher acuity deliveries. Healthcare providers' workload during neonatal resuscitation can be measured using NASATLX and was inversely associated with 5-min Apgar score. Future studies assessing healthcare providers' perceived workload during neonatal resuscitation in different settings are warranted.

An Opportunity for Cognitive Task Analysis in Neonatal Resuscitation.

Approximately 10% of newborn infants require resuscitative intervention at birth. Ideally, this care is provided by a team of expert healthcare professionals who possess exceptional cognitive, psychomotor, and communication skills. Human errors and deviations from resuscitation protocol are common and may be attributable to excessive cognitive demand experienced by the resuscitation team. Cognitive Task Analysis (CTA) is a group of methods used to assess knowledge, judgments, goals, and decision-making of expert healthcare professionals. These methods may be used during neonatal resuscitation to gain an improved understanding of the approaches used by healthcare professionals. CTA methods have been applied in many medical disciplines including neonatology. CTA has been used to identify information previously confined to the intuition of experts. This information has been used to assess, develop, and improve medical technology, clinical decision support tools (DSTs), communication structure, and training methods. Knowledge attained through CTA might be applied similarly to neonatal resuscitation, which may in turn decrease human errors, and improve patient safety.