Observational study of parental opinion of deferred consent for neonatal research.

OBJECTIVE: To evaluate the opinions of parents of newborns following their infant's enrolment into a neonatal research study through the process of deferred consent. DESIGN: Mixed-methods, observational study, interviewing 100 parents recently approached for deferred consent. SETTING: Tertiary-level neonatal intensive care unit, Melbourne, Australia. RESULTS: All 100 parents interviewed had consented to the study/studies using deferred consent; 62% had also experienced a prospective neonatal consent process. Eighty-nine per cent were 'satisfied' with the deferred consent process. The most common reason given for consenting was 'to help future babies'. Negative comments regarding deferred consent mostly related to the timing of the consent approach, and some related to a perceived loss of parental rights. A deferred approach was preferred by 51%, 24% preferred a prospective approach and 25% were unsure. Those who thought prospective consent would not have been preferable cited impaired decision-making, inappropriate timing of an approach before birth and their preference for removal of the decision-making burden via deferred consent. Seventy-seven per cent thought they would have given the same response if approached prospectively; those who would have declined reported that a prospective approach under stressful conditions was unwelcome and too overwhelming. CONCLUSION: In our sample, 89% of parents of infants enrolled in neonatal research using deferred consent considered it acceptable and half would not have preferred prospective consent. The ability to make a more considered decision under less stressful circumstances was key to the acceptability of deferred consent.

2019 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces.

The International Liaison Committee on Resuscitation has initiated a continuous review of new, peer-reviewed, published cardiopulmonary resuscitation science. This is the third annual summary of the International Liaison Committee on Resuscitation International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. It addresses the most recent published resuscitation evidence reviewed by International Liaison Committee on Resuscitation Task Force science experts. This summary addresses the role of cardiac arrest centers and dispatcher-assisted cardiopulmonary resuscitation, the role of extracorporeal cardiopulmonary resuscitation in adults and children, vasopressors in adults, advanced airway interventions in adults and children, targeted temperature management in children after cardiac arrest, initial oxygen concentration during resuscitation of newborns, and interventions for presyncope by first aid providers. Members from 6 International Liaison Committee on Resuscitation task forces have assessed, discussed, and debated the certainty of the evidence on the basis of the Grading of Recommendations, Assessment, Development, and Evaluation criteria, and their statements include consensus treatment recommendations. Insights into the deliberations of the task forces are provided in the Justification and Evidence to Decision Framework Highlights sections. The task forces also listed priority knowledge gaps for further research.

2019 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations.

The International Liaison Committee on Resuscitation has initiated a continuous review of new, peer-reviewed, published cardiopulmonary resuscitation science. This is the third annual summary of the International Liaison Committee on Resuscitation International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. It addresses the most recent published resuscitation evidence reviewed by International Liaison Committee on Resuscitation Task Force science experts. This summary addresses the role of cardiac arrest centers and dispatcher-assisted cardiopulmonary resuscitation, the role of extracorporeal cardiopulmonary resuscitation in adults and children, vasopressors in adults, advanced airway interventions in adults and children, targeted temperature management in children after cardiac arrest, initial oxygen concentration during resuscitation of newborns, and interventions for presyncope by first aid providers. Members from 6 International Liaison Committee on Resuscitation task forces have assessed, discussed, and debated the certainty of the evidence on the basis of the Grading of Recommendations, Assessment, Development, and Evaluation criteria, and their statements include consensus treatment recommendations. Insights into the deliberations of the task forces are provided in the Justification and Evidence to Decision Framework Highlights sections. The task forces also listed priority knowledge gaps for further research.

Respiratory monitors to teach newborn facemask ventilation: a randomised trial.

OBJECTIVE: The International Liaison Committee on Resuscitation has found that there is a need for high-quality randomised trials of training interventions that improve the effectiveness of resuscitation skills. The objective of this study was to determine whether using a respiratory function monitor (RFM) during mask ventilation training with a manikin reduces facemask leak. DESIGN: Stratified, parallel-group, randomised controlled trial. Outcome assessors were blinded to group allocation. SETTING: Thirteen hospitals in Australia, including non-tertiary sites. PARTICIPANTS: Consecutive sample of healthcare professionals attending a structured newborn resuscitation training course. INTERVENTIONS: An RFM providing real-time, objective, leak, flow and volume information was attached to the facemask during 1.5 hours of newborn ventilation and simulation training using a manikin. Participants were randomised to have the RFM display visible (intervention) or masked (control), using a computer-generated randomisation sequence. MAIN OUTCOME MEASURES: The primary outcome was facemask leak measured after neonatal facemask ventilation training. Tidal volume was an important secondary outcome measure. RESULTS: Participants were recruited from May 2016 to November 2017. Of 402 eligible participants, two refused consent. Four hundred were randomised, 200 to each group, of whom 194 in each group underwent analysis. The median (IQR) facemask leak was 23% (8%-41%) in the RFM visible group compared with 35% (14%-67%) in the masked group, p<0.0001, difference (95% CI) in medians 12 (4 to 22). CONCLUSIONS: The display of information from an RFM improved the effectiveness of newborn facemask ventilation training. TRIAL REGISTRATION NUMBER: ACTRN12616000542493, pre-results.

Assessment of resistance of nasal continuous positive airway pressure interfaces.

OBJECTIVE: To compare the resistance of interfaces used for the delivery of nasal continuous positive airway pressure (CPAP) in neonates, as measured by the generated system pressure at fixed gas flows, in an in vitro setting. DESIGN: Gas flows of 6, 8 and 10 L/min were passed through three sizes of each of a selection of available neonatal nasal CPAP interfaces (Hudson prong, RAM Cannula, Fisher & Paykel prong, Infant Flow prong, Fisher & Paykel mask, Infant Flow mask). The expiratory limb was occluded and pressure differential measured using a calibrated pressure transducer. RESULTS: Variation in resistance, assessed by mean pressure differential, was seen between CPAP interfaces. Binasal prong interfaces typically had greater resistance at the smallest assessed sizes, and with higher gas flows. However, Infant Flow prongs produced low pressures (<1.5 cmH2O) at all sizes and gas flows. RAM Cannula had a high resistance, producing a pressure >4.5 cmH2O at all sizes and gas flows. Both nasal mask interfaces had low resistance at all assessed sizes and gas flows, with recorded pressure <1 cmH2O in all cases. CONCLUSIONS: There is considerable variation in measured resistance of available CPAP interfaces at gas flows commonly applied in clinical neonatal care. Use of interfaces with high resistance may result in a greater drop in delivered airway pressure in comparison to set circuit pressure, which may have implications for clinical efficacy. Device manufacturers and clinicians should consider CPAP interface resistance prior to introduction into routine clinical care.

Room Air for Initiating Term Newborn Resuscitation: A Systematic Review With Meta-analysis.

: media-1vid110.1542/5839981898001PEDS-VA_2018-1825Video Abstract CONTEXT: The International Liaison Committee on Resuscitation prioritized to rigorously review the initial fraction of inspired oxygen (Fio2) during resuscitation of newborns. OBJECTIVE: This systematic review and meta-analysis provides the scientific summary of initial Fio2 in term and late preterm newborns (≥35 weeks' gestation) who receive respiratory support at birth. DATA SOURCES: Medline, Embase, Evidence Based Medicine Reviews, and Cumulative Index to Nursing and Allied Health Literature were searched between January 1, 1980 and August 10, 2018. STUDY SELECTION: Studies were selected by pairs of independent reviewers in 2 stages, with a Cohen's κ of 0.8 and 1.0. DATA EXTRACTION: Pairs of independent reviewers extracted data, appraised risk of bias, and assessed Grading of Recommendations Assessment, Development and Evaluation certainty of evidence. RESULTS: Five randomized controlled trials (RCTs) and 5 quasi RCTs included 2164 patients. Room air (Fio2 0.21) was associated with a statistically significant benefit in short-term mortality compared with 100% oxygen (Fio2 1.0) (7 RCTs; n = 1469; risk ratio [RR] = 0.73; 95% confidence interval [CI]: 0.57 to 0.94). No significant differences were observed in neurodevelopmental impairment (2 RCTs; n = 360; RR = 1.41; 95% CI: 0.77 to 2.60) or hypoxic-ischemic encephalopathy (5 RCTs; n = 1315; RR = 0.89; 95% CI: 0.68 to 1.18). LIMITATIONS: The Grading of Recommendations Assessment, Development and Evaluation certainty of evidence was low for short-term mortality and hypoxic-ischemic encephalopathy and very low for neurodevelopmental impairment. CONCLUSIONS: Room air has a 27% relative reduction in short-term mortality compared with Fio2 1.0 for initiating neonatal resuscitation ≥35 weeks' gestation.

Initial Oxygen Use for Preterm Newborn Resuscitation: A Systematic Review With Meta-analysis.

: media-1vid110.1542/5839981895001PEDS-VA_2018-1828Video Abstract CONTEXT: The International Liaison Committee on Resuscitation prioritized to review the initial fraction of inspired oxygen (Fio2) during the resuscitation of preterm newborns. OBJECTIVES: This systematic review and meta-analysis provides the scientific summary of initial Fio2 in preterm newborns (<35 weeks' gestation) who receive respiratory support at birth. DATA SOURCES: Medline, Embase, Evidence-Based Medicine Reviews, and Cumulative Index to Nursing and Allied Health Literature were searched between January 1, 1980 and August 10, 2018. STUDY SELECTION: Studies were selected by pairs of independent reviewers in 2 stages with a Cohen's κ of 0.8 and 1.0. DATA EXTRACTION: Pairs of independent reviewers extracted data, appraised the risk of bias (RoB), and assessed Grading of Recommendations Assessment, Development and Evaluation certainty. RESULTS: Ten randomized controlled studies and 4 cohort studies included 5697 patients. There are no statistically significant benefits of or harms from starting with lower compared with higher Fio2 in short-term mortality (n = 968; risk ratio = 0.83 [95% confidence interval 0.50 to 1.37]), long-term mortality, neurodevelopmental impairment, or other key preterm morbidities. A sensitivity analysis in which 1 study with a high RoB was excluded failed to reveal a reduction in mortality with initial low Fio2 (n = 681; risk ratio = 0.63 [95% confidence interval 0.38 to 1.03]). LIMITATIONS: The Grading of Recommendations Assessment, Development and Evaluation certainty of evidence was very low for all outcomes due to RoB, inconsistency, and imprecision. CONCLUSIONS: The ideal initial Fio2 for preterm newborns is still unknown, although the majority of newborns ≤32 weeks' gestation will require oxygen supplementation.

Very preterm birth before arrival at hospital.

BACKGROUND: Our aim was to report perinatal characteristics of very preterm births before arrival (BBAs) at a hospital, and perinatal and infant mortality rates up to one year, comparing BBAs with births in a hospital. MATERIALS AND METHODS: A population-based cohort study of 22-31 weeks' gestation births in the state of Victoria, Australia from 1990-2009. BBAs were defined as unintentional births at home or on route to hospital. Perinatal data were obtained from the Department of Health and Human Services, Victoria. Perinatal and infant mortality data comparing BBAs with births in hospitals were analysed by logistic regression, adjusted for gestational age, birthweight and sex. RESULTS: One hundred and thirty-three BBAs were recorded: 51 (38%) stillbirths and 82 (62%) livebirths. Compared with births in a hospital, BBAs were less mature (26.3 weeks (SD 2.9) vs 27.7 weeks (SD 2.8), P < 0.001) and a higher proportion were born to teenagers: 13% versus 5% (adjusted odds ratio (aOR) 2.86, P < 0.001). BBAs were significantly more likely to be stillborn (aOR 2.13, 95% confidence interval (CI) 1.41, 3.23, P < 0.001) die within 28 days of livebirth (aOR 2.97, 95% CI 1.54, 5.73, P = 0.001) or die within a year of livebirth (aOR 2.87, 95% CI 1.51, 5.46, P = 0.001) compared with hospital births. Overall, 54 BBAs survived to one year (41% all BBAs, 67% liveborn BBAs), compared with 69% of hospital births (87% of livebirths). CONCLUSIONS: Very preterm birth before arrival is more common in teenagers and is associated with significantly increased risks of perinatal and infant mortality compared with birth in a hospital.

Neonatal mannequin comparison of the Upright self-inflating bag and snap-fit mask versus standard resuscitators and masks: leak, applied load and tidal volumes.

OBJECTIVE: Neonatal mask ventilation is a difficult skill to acquire and maintain. Mask leak is common and can lead to ineffective ventilation. The aim of this study was to determine whether newly available neonatal self-inflating bags and masks could reduce mask leak without additional load being applied to the face. DESIGN: Forty operators delivered 1 min episodes of mask ventilation to a mannequin using the Laerdal Upright Resuscitator, a standard Laerdal infant resuscitator (Laerdal Medical) and a T-Piece Resuscitator (Neopuff), using both the Laerdal snap-fit face mask and the standard Laerdal size 0/1 face mask (equivalent sizes). Participants were asked to use pressure sufficient to achieve 'appropriate' chest rise. Leak, applied load, airway pressure and tidal volume were measured continuously. Participants were unaware that load was being recorded. RESULTS: There was no difference in mask leak between resuscitation devices. Leak was significantly lower when the snap-fit mask was used with all resuscitation devices, compared with the standard mask (14% vs 37% leak, P<0.01). The snap-fit mask was preferred by 83% of participants. The device-mask combinations had no significant effect on applied load. CONCLUSIONS: The Laerdal Upright Resuscitator resulted in similar leak to the other resuscitation devices studied, and did not exert additional load to the face and head. The snap-fit mask significantly reduced overall leak with all resuscitation devices and was the mask preferred by participants.

Outcomes of infants born at 22-27 weeks' gestation in Victoria according to outborn/inborn birth status.

OBJECTIVES: To compare mortality and serious morbidity rates between outborn and inborn livebirths at 22-27 weeks' gestation. DESIGN: Population-based cohort study. SETTING: Victoria, Australia. PATIENTS: Livebirths at 22-27 weeks' gestation free of major malformations in 2010-2011. INTERVENTIONS: Outcome data for outborn (born outside a tertiary perinatal centre) infants compared with inborn (born in a tertiary perinatal centre) infants were analysed by logistic regression, adjusted for gestational age, birth weight and sex. MAIN OUTCOME MEASURES: Infant mortality and serious morbidity rates to hospital discharge. RESULTS: 541 livebirths free of major malformations were recorded. By 1 year, 49 (58%) outborns and 140 (31%) inborns died (adjusted OR (aOR) 2.78, 95% CI 1.52 to 5.09, p=0.001). In total, 445 infants were admitted to neonatal intensive care unit (NICU); 93 died by 1 year (14/49 outborns and 79/396 inborns), (aOR 1.75, 95% CI 0.87 to 3.55, p=0.12). There were no significant differences in rates of necrotising enterocolitis, intraventricular haemorrhage, retinopathy of prematurity, bronchopulmonary dysplasia (BPD) or the combined outcome of death or BPD in outborn infants compared with inborn infants. Outborns had an increased risk of cystic periventricular leukomalacia (cPVL) compared with inborns (12.2% vs 2.8%, respectively; aOR 5.34, 95% CI 1.84 to 15.54, p=0.002). CONCLUSIONS: Mortality rates remained higher for outborn livebirths at 22-27 weeks' gestation compared with inborn peers in 2010-2011. Outborn infants admitted to NICU did not have substantially different rates of mortality or serious morbidity compared with inborns, with the exception of cPVL. Longer-term health consequences of outborn birth before 28 weeks' gestation need to be determined.

What are we telling the parents of extremely preterm babies?

BACKGROUND: Parent counselling and decision-making regarding the management of preterm labour and birth are influenced by information provided by healthcare professionals regarding potential infant outcomes. AIM: The aim of this study was to determine whether perinatal healthcare providers had accurate perceptions of survival and major neurosensory disability rates of very preterm infants born in non-tertiary hospitals ('outborn') and tertiary perinatal centres ('inborn'). MATERIALS AND METHODS: A web-based survey was distributed to midwives, nurses, obstetricians and neonatologists working in non-tertiary and tertiary maternity hospitals, and the perinatal/neonatal emergency transport services in Victoria, Australia. MAIN OUTCOME MEASURES: Estimates of survival rates at 24 and 28-weeks' gestation were compared with actual survival rates of a population-based cohort of 24 and 28-weeks' gestation infants, born free of lethal anomalies in Victoria in 2001-2009. Estimates of major neurosensory disability rates in 24 and 28-week survivors were compared with actual disability rates in 24 and 28-week children born in Victoria averaged over three eras: 1991-1992, 1997 and 2005. RESULTS: Response rates varied as follows: 83% of non-tertiary midwives, 4% of obstetricians, 55% of tertiary centre staff and 68% of transport team staff responded (total of 30%). Overall, respondents underestimated survival and overestimated major neurosensory disability rates in both outborn and inborn 24 and 28-week infants. Outborn infants were perceived to have much worse prospects for survival and for survival with major disability compared with inborn peers. CONCLUSION: Many clinicians overestimated rates of adverse outcomes. These clinicians may be misinforming parents about their child's potential for a favourable outcome.

Why birthplace still matters for infants born before 32 weeks: Infant mortality associated with birth at 22-31 weeks' gestation in non-tertiary hospitals in Victoria over two decades.

BACKGROUND: Very preterm infants born in non-tertiary hospitals ('outborn') are known to have higher mortality rates compared with infants 'inborn' in tertiary centres. AIM: The aim of this study was to report changes over time in the incidence of outborn livebirths, 22-31 weeks and infant mortality rates for outborn compared with inborn births. METHODS: We conducted a population-based cohort study of consecutive livebirths, 22-31 weeks' gestation in Victoria from 1990 to 2009. The relationship between birthplace, gestational age, birthweight, sex and infant mortality were analysed by logistic regression. RESULTS: There were 13,760 livebirths, 22-31 weeks: 14% were outborn. The proportion of outborn livebirths fell from 19% in 1991 to a nadir of 9% in 1997, but climbed to 17% by 2009. At all times, outborns had higher mortality rates compared with inborns. The overall infant mortality rate was 250.6 per 1000 outborn compared with 113.3 per 1000 inborn livebirths (adjusted odds ratio (aOR) 2.76 (95% CI 2.32, 3.27, P < 0.001). There were no differences between outborn and inborn mortality risks for 22-week livebirths (OR 7.04, 95% CI 0.87, 56.8, P = 0.067), but there were at 23-27 weeks (aOR 3.16, 95% CI 2.52, 3.96, P < 0.001) and at 28-31 weeks (aOR 1.66, 95% CI 1.19, 2.31, P = 0.003). Over time, mortality rates fell for inborn 23-27 week infants. Mortality rates fell for outborn 23-27 week infants in 1990-2005, but rose in 2006-2009. CONCLUSIONS: Outborn livebirths at 22-31 weeks' gestation occur too frequently and are associated with a significantly increased risk of mortality. Strategies to reduce outborn livebirths are required.

New concepts in neonatal resuscitation.

PURPOSE OF REVIEW: There has been a substantial increase in the number of studies of neonatal resuscitation and it is timely to review the accumulating evidence. RECENT FINDINGS: There have been major changes in the way that newly born infants are managed in the delivery room. Colour is no longer recommended as a useful indicator of oxygenation or effectiveness of resuscitation. Pulse oximetry provides rapid, continuous and accurate information on both oxygenation and heart rate. Resuscitation of term infants should begin with air, with the provision of blended oxygen to maintain oxygen saturations similar to those of term infants requiring no resuscitation. Positive end-expiratory pressure during initial ventilation aids lung aeration and establishment of functional residual capacity. Respiratory function monitoring allows operators to identify factors adversely affecting ventilation, including leak around the face mask and airway obstruction. Clamping of the umbilical cord should be delayed for at least 1 min for infants not requiring resuscitation. SUMMARY: The International Liaison Committee on Resuscitation guidelines on the management of newborn infants were updated in 2010 and incorporate much of the newly available evidence. The use of intensive care techniques in the delivery room is promising but requires further evaluation. Monitoring techniques and interventions need to be adapted for use in developing countries.

The Australian Safe-n-Sound Baby Safety Capsule and its effect on oxygen saturation values in infants ready for discharge home.

PURPOSE: To examine the effect of Australian Safe-n-Sound Baby Safety Capsule (BSC) on oxygen saturation (SpO2) values of preterm and term infants ready for discharge home. DESIGN: A two-group pretest/protest quasi-experimental study compared the effect of the BSC on SpO2. SAMPLE: Thirty-nine low birth weight premature newborn infants and 19 term newborn infants ready for discharge home. MAIN OUTCOME VARIABLE: Mean oxygen saturation values and the number of oxygen desaturation events below 90 percent. RESULTS: The mean SpO2 values for both preterm and term infants were within the normal range (>90-100 percent) for each phase of data collection (baseline, capsule, and recovery). However, mean SpO2 values decreased from baseline during the 60 minutes spent in the BSC for the preterm infants.