The use of high-flow nasal cannulae is an increasingly popular alternative to nasal continuous positive airway pressure (CPAP) for noninvasive respiratory support of very preterm infants (gestational ...age, <32 weeks) after extubation. However, data on the efficacy or safety of such cannulae in this population are lacking.
In this multicenter, randomized, noninferiority trial, we assigned 303 very preterm infants to receive treatment with either high-flow nasal cannulae (5 to 6 liters per minute) or nasal CPAP (7 cm of water) after extubation. The primary outcome was treatment failure within 7 days. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome; the margin of noninferiority was 20 percentage points. Infants in whom treatment with high-flow nasal cannulae failed could be treated with nasal CPAP; infants in whom nasal CPAP failed were reintubated.
The use of high-flow nasal cannulae was noninferior to the use of nasal CPAP, with treatment failure occurring in 52 of 152 infants (34.2%) in the nasal-cannulae group and in 39 of 151 infants (25.8%) in the CPAP group (risk difference, 8.4 percentage points; 95% confidence interval, -1.9 to 18.7). Almost half the infants in whom treatment with high-flow nasal cannulae failed were successfully treated with CPAP without reintubation. The incidence of nasal trauma was significantly lower in the nasal-cannulae group than in the CPAP group (P=0.01), but there were no significant differences in rates of serious adverse events or other complications.
Although the result for the primary outcome was close to the margin of noninferiority, the efficacy of high-flow nasal cannulae was similar to that of CPAP as respiratory support for very preterm infants after extubation. (Funded by the National Health and Medical Research Council; Australian New Zealand Clinical Trials Network number, ACTRN12610000166077.).
Treatment with nasal high-flow therapy has efficacy similar to that of nasal continuous positive airway pressure (CPAP) when used as postextubation support in neonates. The efficacy of high-flow ...therapy as the primary means of respiratory support for preterm infants with respiratory distress has not been proved.
In this international, multicenter, randomized, noninferiority trial, we assigned 564 preterm infants (gestational age, ≥28 weeks 0 days) with early respiratory distress who had not received surfactant replacement to treatment with either nasal high-flow therapy or nasal CPAP. The primary outcome was treatment failure within 72 hours after randomization. Noninferiority was determined by calculating the absolute difference in the risk of the primary outcome; the chosen margin of noninferiority was 10 percentage points. Infants in whom high-flow therapy failed could receive rescue CPAP; infants in whom CPAP failed were intubated and mechanically ventilated.
Trial recruitment stopped early at the recommendation of the independent data and safety monitoring committee because of a significant difference in the primary outcome between treatment groups. Treatment failure occurred in 71 of 278 infants (25.5%) in the high-flow group and in 38 of 286 infants (13.3%) in the CPAP group (risk difference, 12.3 percentage points; 95% confidence interval CI, 5.8 to 18.7; P<0.001). The rate of intubation within 72 hours did not differ significantly between the high-flow and CPAP groups (15.5% and 11.5%, respectively; risk difference, 3.9 percentage points; 95% CI, -1.7 to 9.6; P=0.17), nor did the rate of adverse events.
When used as primary support for preterm infants with respiratory distress, high-flow therapy resulted in a significantly higher rate of treatment failure than did CPAP. (Funded by the National Health and Medical Research Council and others; Australian New Zealand Clinical Trials Registry number, ACTRN12613000303741 .).
Objectives To identify variables that predict extubation success in extremely preterm infants born <28 weeks gestational age (GA), and to compare outcomes between those who had successful or failed ...extubation. Study design A secondary analysis of data from a randomized trial of postextubation respiratory support that included 174 extremely preterm infants. “Extubation success” was defined as not requiring reintubation within 7 days, and “extubation failure” the converse. Predictive variables that were different between groups were included in a multivariable logistic regression model. Results Sixty-eight percent of infants were successfully extubated. Compared with those infants who had extubation failure, they had a higher GA and birth weight, were extubated earlier, were more often exposed to prolonged ruptured membranes, more often avoided intubation in the delivery room, had a higher pre-extubation pH, and had lower mean pre-extubation fraction of inspired oxygen and partial pressure of carbon dioxide (PCO2 ). Only GA and PCO2 remained significant in the multivariable analysis (area under a receiver operating characteristic curve = 0.81). Extubation failure was associated with death, bronchopulmonary dysplasia, severe retinopathy of prematurity, patent ductus arteriosus ligation, and longer durations of respiratory support, oxygen supplementation, and hospitalization. When adjusted for allocated treatment in the randomized trial, GA, and birth weight z-score, extubation failure remained associated with death before discharge and prolonged respiratory support and hospitalization. Conclusions In extremely preterm infants, higher GA and lower pre-extubation PCO2 predicted extubation success. Infants in whom extubation failed were more likely to die and have prolonged respiratory support and hospitalization. Trial registration Australian New Zealand Clinical Trials Network: ACTRN12610000166077.
Aim
This review examined how applicable national and regional clinical practice guidelines and recommendations for managing neonates born to mothers with COVID‐19 mothers were to the evolving ...pandemic.
Methods
A systematic search and review identified 20 guidelines and recommendations that had been published by May 25, 2020. We analysed documents from 17 countries: Australia, Brazil, Canada, China, France, India, Italy, Japan, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, the UK and the United States.
Results
The documents were based on expert consensus with limited evidence and were of variable, low methodological rigour. Most did not provide recommendations for delivery methods or managing symptomatic infants. None provided recommendations for post‐discharge assimilation of potentially infected infants into the community. The majority encouraged keeping mothers and infants together, subject to infection control measures, but one‐third recommended separation. Although breastfeeding or using breastmilk was widely encouraged, two countries specifically prohibited this.
Conclusion
The guidelines and recommendations for managing infants affected by COVID‐19 were of low, variable quality and may be unsustainable. It is important that transmission risks are not increased when new information is incorporated into clinical recommendations. Practice guidelines should emphasise the extent of uncertainty and clearly define gaps in the evidence.
Summary Effective resuscitation of the newborn infant has the potential to save many lives around the world and reduce disabilities in children who survive peripartum asphyxia. In this Series paper, ...we highlight some of the important advances in the understanding of how best to resuscitate newborn infants, which includes monitoring techniques to guide resuscitative efforts, increasing awareness of the adverse effects of hyperoxia, delayed umbilical cord clamping, the avoidance of routine endotracheal intubation for extremely preterm infants, and therapeutic hypothermia for hypoxic–ischaemic encephalopathy. Despite the challenges of performing high-quality clinical research in the delivery room, researchers continue to refine and advance our knowledge of effective resuscitation of newborn infants through scientific experiments and clinical trials.
Neonatal endotracheal intubation often involves more than one attempt, and oxygen desaturation is common. It is unclear whether nasal high-flow therapy, which extends the time to desaturation during ...elective intubation in children and adults receiving general anesthesia, can improve the likelihood of successful neonatal intubation on the first attempt.
We performed a randomized, controlled trial to compare nasal high-flow therapy with standard care (no nasal high-flow therapy or supplemental oxygen) in neonates undergoing oral endotracheal intubation at two Australian tertiary neonatal intensive care units. Randomization of intubations to the high-flow group or the standard-care group was stratified according to trial center, the use of premedication for intubation (yes or no), and postmenstrual age of the infant (≤28 or >28 weeks). The primary outcome was successful intubation on the first attempt without physiological instability (defined as an absolute decrease in the peripheral oxygen saturation of >20% from the preintubation baseline level or bradycardia with a heart rate of <100 beats per minute) in the infant.
The primary intention-to-treat analysis included the outcomes of 251 intubations in 202 infants; 124 intubations were assigned to the high-flow group and 127 to the standard-care group. The infants had a median postmenstrual age of 27.9 weeks and a median weight of 920 g at the time of intubation. A successful intubation on the first attempt without physiological instability was achieved in 62 of 124 intubations (50.0%) in the high-flow group and in 40 of 127 intubations (31.5%) in the standard-care group (adjusted risk difference, 17.6 percentage points; 95% confidence interval CI, 6.0 to 29.2), for a number needed to treat of 6 (95% CI, 4 to 17) for 1 infant to benefit. Successful intubation on the first attempt regardless of physiological stability was accomplished in 68.5% of the intubations in the high-flow group and in 54.3% of the intubations in the standard-care group (adjusted risk difference, 15.8 percentage points; 95% CI, 4.3 to 27.3).
Among infants undergoing endotracheal intubation at two Australian tertiary neonatal intensive care units, nasal high-flow therapy during the procedure improved the likelihood of successful intubation on the first attempt without physiological instability in the infant. (Funded by the National Health and Medical Research Council; Australian New Zealand Clinical Trials Registry number, ACTRN12618001498280.).
Summary Preterm birth rates are rising, and many preterm infants have breathing difficulty after birth. Treatments for infants with prolonged breathing difficulty include oxygen therapy, exogenous ...surfactant, various modes of respiratory support, and postnatal corticosteroids. In this Series paper, we review the history of neonatal respiratory care and its effect on long-term outcomes, and we outline the future direction of the research field. The delivery and monitoring of oxygen therapy remains controversial, despite being in use for more than 50 years. Exogenous surfactant replacement has been used for 25 years and has dramatically reduced mortality and morbidity, but more research on when and how it is administered is needed. Methods and techniques of neonatal respiratory support are evolving. Clinicians are moving away from routine intubation and ventilation, and new modes of non-invasive support are being investigated. Postnatal corticosteroids have a limited role in infants with evolving bronchopulmonary dysplasia, but more research is needed to identify the best timing, type, dose, and method of administration. Despite advances in neonatal care in the past 50 years, bronchopulmonary dysplasia, with all its adverse short-term and long-term consequences, is still a serious problem in neonatal care. The challenge remains to support breathing in preterm infants, with special attention to risk factors in the subpopulation of infants that are at highest risk of bronchopulmonary dysplasia, without damaging their lungs or adversely affecting their long-term health.
Summary The use of nasal intermittent positive pressure ventilation (NIPPV) as respiratory support for preterm infants is well established. Evidence from randomized trials indicates that NIPPV is ...advantageous over continuous positive airway pressure (CPAP) as post-extubation support, albeit with varied outcomes between NIPPV techniques. Randomized data comparing NIPPV with CPAP as primary support, and for the treatment of apnea, are conflicting. Intrepretation of outcomes is limited by the multiple techniques and devices used to generate and deliver NIPPV. This review discusses the potential mechanisms of action of NIPPV in preterm infants, the evidence from clinical trials, and summarizes recommendations for practice.
The survival and health of preterm and critically ill infants have markedly improved over the past 50 years, supported by well‐conducted neonatal research. However, newborn research is difficult to ...undertake for many reasons, and obtaining informed consent for research in this population presents several unique ethical and logistical challenges. In this article, we explore methods to facilitate the consent process, including the role of checklists to support meaningful informed consent for neonatal clinical trials.
Conclusion
The authors provide practical guidance on the design and implementation of an effective consent checklist tailored for use in neonatal clinical research.
Aim
To identify current ‘Golden Hour’ practices for initial stabilisation of very preterm infants <32 weeks' gestational age (GA) within tertiary neonatal intensive care units (NICUs) in the ...Australian and New Zealand Neonatal Network (ANZNN).
Methods
A 76‐question survey regarding delivery room (DR) and NICU stabilisation practices was distributed electronically to directors of tertiary perinatal NICUs in the ANZNN in January 2019. Responses were categorised into GA subgroups: 23–24, 25–27 and 28–31 weeks' GA.
Results
The response rate was 100% (24/24 units). Delayed cord clamping (DCC) was practised ‘always’ or ‘often’ by 21 units (88%). All units used oximetry to target oxygen saturations, and 23/24 (96%) commenced resuscitation in <40% oxygen.
Ten units (42%) routinely used DR electrocardiography monitoring. CPAP was preferred as primary respiratory support in one‐third of units for infants born 23–24 weeks' GA, compared with 19 units (79%) at 25–27 weeks' GA and 23 units (96%) at 28–31 weeks' GA. DR skin‐to‐skin care was uncommon, particularly at lower GAs. Five units (21%) used minimally invasive surfactant therapy for non‐intubated infants at 23–24 weeks' GA, 13 units (54%) at 25–27 weeks' GA and 16 units (67%) at 28–31 weeks' GA.
Conclusions
Most Golden Hour stabilisation practices align with international guidelines. Consistency exists with respect to DCC, oxygen saturation targeting and primary CPAP use for infants 25 weeks' GA and above. Where evidence is less certain, practices vary across ANZNN NICUs. Time targets for stabilisation measures may help standardise practice for this population.
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