Direct laryngoscopy versus indirect videolaryngoscopy for intubating newborn manikins: a randomised crossover study.

Gaining and maintaining proficiency at endotracheal intubation is challenging. Recent clinical trials suggest videolaryngoscopy is beneficial for teaching inexperienced clinicians to intubate newborn infants, but may take longer compared to standard laryngoscopy. Preferences for devices among clinicians are unclear. Simulation studies using manikins have shown that use of videolaryngoscopes (VLs) likely improves intubation outcomes, at least in the short term. This study is the first to compare different VLs and SL as they are designed in clinicians with varying levels of experience in term and preterm manikins. This setup more closely mimics real-life clinical practice in comparison to trials exclusively of novices or using VL devices to intubate directly. Our study is relevant to members of the perinatal and neonatal clinical care team and related to using technology to improve neonatal outcomes. It is of particular importance in the current environment of reduced opportunities to learn and maintain neonatal intubation skills due to changes in neonatal practice and clinical care.

Video versus Direct Laryngoscopy for Urgent Intubation of Newborn Infants.

BACKGROUND: Repeated attempts at endotracheal intubation are associated with increased adverse events in neonates. When clinicians view the airway directly with a laryngoscope, fewer than half of first attempts are successful. The use of a video laryngoscope, which has a camera at the tip of the blade that displays a view of the airway on a screen, has been associated with a greater percentage of successful intubations on the first attempt than the use of direct laryngoscopy in adults and children. The effect of video laryngoscopy among neonates is uncertain. METHODS: In this single-center trial, we randomly assigned neonates of any gestational age who were undergoing intubation in the delivery room or neonatal intensive care unit (NICU) to the video-laryngoscopy group or the direct-laryngoscopy group. Randomization was stratified according to gestational age (<32 weeks or ≥32 weeks). The primary outcome was successful intubation on the first attempt, as determined by exhaled carbon dioxide detection. RESULTS: Data were analyzed for 214 of the 226 neonates who were enrolled in the trial, 63 (29%) of whom were intubated in the delivery room and 151 (71%) in the NICU. Successful intubation on the first attempt occurred in 79 of the 107 patients (74%; 95% confidence interval [CI], 66 to 82) in the video-laryngoscopy group and in 48 of the 107 patients (45%; 95% CI, 35 to 54) in the direct-laryngoscopy group (P<0.001). The median number of attempts to achieve successful intubation was 1 (95% CI, 1 to 1) in the video-laryngoscopy group and 2 (95% CI, 1 to 2) in the direct-laryngoscopy group. The median lowest oxygen saturation during intubation was 74% (95% CI, 65 to 78) in the video-laryngoscopy group and 68% (95% CI, 62 to 74) in the direct-laryngoscopy group; the lowest heart rate was 153 beats per minute (95% CI, 148 to 158) and 148 (95% CI, 140 to 156), respectively. CONCLUSIONS: Among neonates undergoing urgent endotracheal intubation, video laryngoscopy resulted in a greater number of successful intubations on the first attempt than direct laryngoscopy. (Funded by the National Maternity Hospital Foundation; VODE ClinicalTrials.gov number, NCT04994652.).

Maternal Graves Disease Postthyroidectomy With Fetal Thyrotoxicosis and Goiter.

Fetal thyrotoxicosis is a rare condition with high morbidity and mortality. It may complicate pregnancies in women with a history of Graves disease (GD) when transplacental passage of maternal TSH receptor antibodies stimulate the fetal thyroid gland and cause hyperthyroidism. We report the case of a 34-year-old woman with a history of GD and prior thyroidectomy, where fetal thyrotoxicosis at 21 weeks of gestation was suspected due to prenatal ultrasound findings of cardiac failure and fetal goiter. She was treated with high-dose carbimazole and followed closely by a multidisciplinary team. Her baby was delivered in good condition at 34 weeks' gestation and developed hyperthyroidism in the days after birth, which was successfully treated medically. This case highlights the importance of awareness of the condition among women with a history of GD, as well as the necessity for prompt diagnosis and treatment of this complex disease.

Thermoregulation for very preterm infants in the delivery room: a narrative review.

Abnormal temperature in preterm infants is associated with increased morbidity and mortality. Infants born prematurely are at risk of abnormal temperature immediately after birth in the delivery room (DR). The World Health Organization (WHO) recommends that the temperature of newly born infants is maintained between 36.5-37.5oC after birth. When caring for very preterm infants, the International Liaison Committee on Resuscitation (ILCOR) recommends using a combination of interventions to prevent heat loss. While hypothermia remains prevalent, efforts to prevent it have increased the incidence of hyperthermia, which may also be harmful. Delayed cord clamping (DCC) for preterm infants has been recommended by ILCOR since 2015. Little is known about the effect of timing of DCC on temperature, nor have there been specific recommendations for thermal care before DCC. This review article focuses on the current evidence and recommendations for thermal care in the DR, and considers thermoregulation in the context of emerging interventions and future research directions. IMPACT: Abnormal temperature is common amongst very preterm infants after birth, and is an independent risk factor for mortality. The current guidelines recommend a combination of interventions to prevent heat loss after birth. Despite this, abnormal temperature is still a problem, across all climates and economies. New and emerging delivery room practice (i.e., delayed cord clamping, mobile resuscitation trolleys, early skin to skin care) may have an effect on infant temperature. This article reviews the current evidence and recommendations, and considers future research directions.

Prophylactic Oropharyngeal Surfactant for Preterm Newborns at Birth: A Randomized Clinical Trial.

Importance: Preterm newborns at risk of respiratory distress syndrome are supported with continuous positive airway pressure (CPAP). Many newborns worsen despite CPAP and are intubated for surfactant administration, an effective therapy for treatment of respiratory distress syndrome. Endotracheal intubation is associated with adverse effects. Pharyngeal administration of surfactant to preterm animals and humans has been reported as an alternative. Objective: To assess whether giving prophylactic oropharyngeal surfactant to preterm newborns at birth would reduce the rate of intubation for respiratory failure. Design, Setting, and Participants: This unblinded, parallel-group randomized clinical trial (Prophylactic Oropharyngeal Surfactant for Preterm Infants [POPART]) was conducted from December 17, 2017, to September 11, 2020, at 9 tertiary neonatal intensive care units in 6 European countries. Newborns born before 29 weeks of gestation without severe congenital anomalies, for whom intensive care was planned, were eligible for inclusion. The data were analyzed from July 27, 2022, to June 20, 2023. Intervention: Newborns were randomly assigned to receive oropharyngeal surfactant at birth in addition to CPAP or CPAP alone. Randomization was stratified by center and gestational age (GA). Main Outcomes and Measures: The primary outcome was intubation in the delivery room for bradycardia and/or apnea or in the neonatal intensive care unit for prespecified respiratory failure criteria within 120 hours of birth. Caregivers were not masked to group assignment. Results: Among 251 participants (mean [SD] GA, 26 [1.5] weeks) who were well matched at study entry, 126 (69 [54.8%] male) with a mean (SD) birth weight of 858 (261) grams were assigned to the oropharyngeal surfactant group, and 125 (63 [50.4%] male) with a mean (SD) birth weight of 829 (253) grams were assigned to the control group. The proportion of newborns intubated within 120 hours was not different between the groups (80 [63.5%) in the oropharyngeal surfactant group and 81 [64.8%] in the control group; relative risk, 0.98 [95% CI, 0.81-1.18]). More newborns assigned to the oropharyngeal surfactant group were diagnosed with and treated for pneumothorax (21 [16.6%] vs 8 [6.4%]; P = .04). Conclusions and Relevance: This randomized clinical trial found that administration of prophylactic oropharyngeal surfactant to newborns born before 29 weeks' GA did not reduce the rate of intubation in the first 120 hours of life. These findings suggest that administration of surfactant into the oropharynx immediately after birth in addition to CPAP should not be routinely used. Trial Registration: EudraCT: 2016-004198-41.

The history of neonatal intubation.

Interest in 'resurrecting' the lifeless by supporting breathing has been described since ancient times. For centuries, methods of resuscitating animals, then humans and specifically the 'lifeless' neonate were debated and discussed. Over time, with experimentation and worldwide collaboration, endotracheal tubes and laryngoscopes specific to the newborn were created and their use refined. This historical work has meant that today, the neonatal community focuses on refining the science and the art of intubation for the benefit of the newborn; who, where, when and how to intubate, with what devices and medications, bringing about significant change in the area of neonatal intubation. Recent work has focused on alternatives to neonatal intubation as the risks of endotracheal intubation and mechanical ventilation have become clearer. Appreciating the history of neonatal intubation and its (somewhat cyclical) changes over time can show us how far we've come and how far we can still go in the resuscitation and respiratory support of newborns.

Research in the Delivery Room: Can You Tell Me It's Evolution?

Many of the recommendations for newborn care in the delivery room (DR) are based on retrospective observational studies, preclinical studies of mannequins or animal models, and expert opinion. Conducting DR research is challenging. Many deliveries occur in fraught circumstances with little prior warning, making it difficult to get prospective consent from parents and buy-in from clinicians. Many DR interventions are difficult to mask for the purpose of a clinical trial and it is not easy to identify appropriate outcomes for studies that are sufficiently "short-term" that they are likely to be influenced by the intervention, yet sufficiently "long-term" to be considered clinically important. However, despite these challenges, much information has been accrued from clinical studies in recent years. In this article, we outline our experience of conducting clinical research in the DR. In our initial studies almost 20 years ago, we found wide variation in the equipment used both nationally and internationally, reflecting the paucity of evidence to support practice. This started a journey that has included many observational studies and randomized controlled trials that have attempted to refine how we care for newborn infants in the DR. Each has given further information and, inevitably, raised many more questions about the approach to caring for newborns in the DR.

Survey on currently applied interventions in neonatal resuscitation (SCIN): A study protocol.

Introduction: Around 140 million children are born every year and post-natal transition is uncomplicated in the vast majority. However, around 5%-15% of neonates receive supportive interventions during transition. Recent data on the interventions used is scarce. More data on the frequencies with which these interventions are used is needed to evaluate neonatal resuscitation, guide recommendations and to generate hypotheses for further research. The following protocol describes an international, multicentre survey on the interventions currently applied during neonatal resuscitation. Objectives: To determine the frequencies at which different supportive interventions recommended by European Resuscitation Council (ERC) guidelines for neonatal resuscitation are used. To compare the frequencies between hospitals and patient groups and to investigate possible factors influencing any differences found. Methods: Participating hospitals will collect data on all interventions performed during neonatal resuscitation over a period of 6 months. All hospitals providing perinatal care are eligible regardless of size and designated level of neonatal care. Every neonate requiring more interventions than basic drying and tactile stimulation during the first 30 min of life will be included. The targeted sample size is at least 4,000 neonates who receive interventions. After anonymization, the data is pooled in a common database and descriptive and statistical analysis is performed globally and in subgroups. Possible correlations will be investigated with phi coefficient and chi square testing. Ethics and dissemination: Consent of the institutional review board of the Technical University Dresden was obtained for the local data collection under the number BO-EK-198042022. Additionally, approval of local ethical or institutional review boards will be obtained by the participating hospitals if required. Results will be published in peer-reviewed journals and presented at suitable scientific conferences.

Immunological assessment of SARS-CoV-2 infection in pregnancy from diagnosis to delivery: A multicentre prospective study.

BACKGROUND: Background Population-based data on SARS-CoV-2 infection in pregnancy and assessment of passive immunity to the neonate, is lacking. We profiled the maternal and fetal response using a combination of viral RNA from naso-pharyngeal swabs and serological assessment of antibodies against SARS-CoV-2. METHODS: This multicentre prospective observational study was conducted between March 24th and August 31st 2020. Two independent cohorts were established, a symptomatic SARS-CoV-2 cohort and a cohort of asymptomatic pregnant women attending two of the largest maternity hospitals in Europe. Symptomatic women were invited to provide a serum sample to assess antibody responses. Asymptomatic pregnant women provided a nasopharyngeal swab and serum sample. RT-PCR for viral RNA was performed using the Cobas SARS-CoV-2 6800 platform (Roche). Umbilical cord bloods were obtained at delivery. Maternal and fetal serological response was measured using both the Elecsys® Anti-SARS-CoV-2 immunoassay (Roche), Abbott SARS-CoV-2 IgG Assay and the IgM Architect assay. Informed written consent was obtained from all participants. RESULTS: Ten of twenty three symptomatic women had SARS-CoV-2 RNA detected on nasopharyngeal swabs. Five (5/23, 21.7%) demonstrated serological evidence of anti-SARS-CoV-2 IgG antibodies and seven (30.4%, 7/23) were positive for IgM antibodies. In the asymptomatic cohort, the prevalence of SARS-CoV-2 infection in RNA was 0.16% (1/608). IgG SARS-CoV-2 antibodies were detected in 1·67% (10/598, 95% CI 0·8%-3·1%) and IgM in 3·51% (21/598, 95% CI 2·3-5·5%). Nine women had repeat testing post the baseline test. Four (4/9, 44%) remained IgM positive and one remained IgG positive. 3 IgG anti-SARS-CoV-2 antibodies were detectable in cord bloods from babies born to five seropositive women who delivered during the study. The mean gestation at serological test was 34 weeks. The mean time between maternal serologic positivity and detection in umbilical cord samples was 28 days. CONCLUSION: Using two independent serological assays, we present a comprehensive illustration of the antibody response to SARS-CoV-2 in pregnancy, and show a low prevalence of asymptomatic SARS-CoV2. Transplacental migration of anti-SARS-CoV-2 antibodies was identified in cord blood of women who demonstrated antenatal anti-SARS-CoV-2 antibodies, raising the possibility of passive immunity.

Cerebral oxygen saturation and autoregulation during hypotension in extremely preterm infants.

BACKGROUND: The impact of the permissive hypotension approach in clinically well infants on regional cerebral oxygen saturation (rScO2) and autoregulatory capacity (CAR) remains unknown. METHODS: Prospective cohort study of blinded rScO2 measurements within a randomized controlled trial of management of hypotension (HIP trial) in extremely preterm infants. rScO2, mean arterial blood pressure, duration of cerebral hypoxia, and transfer function (TF) gain inversely proportional to CAR, were compared between hypotensive infants randomized to receive dopamine or placebo and between hypotensive and non-hypotensive infants, and related to early intraventricular hemorrhage or death. RESULTS: In 89 potentially eligible HIP trial patients with rScO2 measurements, the duration of cerebral hypoxia was significantly higher in 36 hypotensive compared to 53 non-hypotensive infants. In 29/36 hypotensive infants (mean GA 25 weeks, 69% males) receiving the study drug, no significant difference in rScO2 was observed after dopamine (n = 13) compared to placebo (n = 16). Duration of cerebral hypoxia was associated with early intraventricular hemorrhage or death.  Calculated TF gain (n = 49/89) was significantly higher reflecting decreased CAR in 16 hypotensive compared to 33 non-hypotensive infants. CONCLUSIONS: Dopamine had no effect on rScO2 compared to placebo in hypotensive infants. Hypotension and cerebral hypoxia are associated with early intraventricular hemorrhage or death. IMPACT: Treatment of hypotension with dopamine in extremely preterm infants increases mean arterial blood pressure, but does not improve cerebral oxygenation. Hypotensive extremely preterm infants have increased duration of cerebral hypoxia and reduced cerebral autoregulatory capacity compared to non-hypotensive infants. Duration of cerebral hypoxia and hypotension are associated with early intraventricular hemorrhage or death in extremely preterm infants. Since systematic treatment of hypotension may not be associated with better outcomes, the diagnosis of cerebral hypoxia in hypotensive extremely preterm infants might guide treatment.

Initiation of respiratory support for extremely preterm infants at birth.

Neonatal resuscitation algorithms recommend assessing breathing and heart rate (HR) of newborns and giving respiratory support when one or both are unsatisfactory. Recommendations also state that preterm infants may be supported with continuous positive airway pressure rather than routinely intubated for positive pressure ventilation (PPV). We wished to describe the prevalence and time of initiation of respiratory support of extremely preterm and extremely low birthweight (ELBW) infants at our hospital. We reviewed videos of 55 infants. Although most were breathing, practically all newly born extremely preterm ELBW infants were given respiratory support soon after arrival to the resuscitation cot. For the majority, this was done without knowing the HR. The majority received PPV; again, this was often done without knowing the HR. A quarter of infants were managed without any PPV.

Effect of Early Parenteral Nutrition Discontinuation on Time to Regain Birth Weight in Very Low Birth Weight Infants: A Randomized Controlled Trial.

BACKGROUND: Peripherally inserted central catheters (PICCs) are used to administer parenteral nutrition (PN) in very low birth weight infants (VLBW; <1500 g). Clinicians try to optimize early nutrition but also minimize the risks associated with intravascular devices. The objective of this study was to examine the early nutrition impact of discontinuing PN at different enteral feed volumes in VLBW infants. METHODS: In this unmasked, multicenter, randomized controlled trial, patients were randomly assigned to PICC removal and PN discontinuation at an enteral feed volume of 100 mL/kg/day (intervention) or 140 mL/kg/day (control). Clinically stable VLBW infants with a PICC in situ who were receiving PN were eligible for inclusion. Infants with major congenital anomalies were excluded. A total of 139 patients were enrolled; 69 and 70 patients were randomized to the intervention and control groups, respectively. The primary outcome measure was the mean difference in time (days) to regain birth weight. RESULTS: The groups were well matched at study entry. Patients in the intervention group regained birth weight more slowly (mean difference 1.5 days CI: 0.3-2.7 days, P = 0.01). The mean difference in time to regain birth weight for infants <1000 g was 2.8 days (95% CI: 0.8-4.8 days, P = 0.008). CONCLUSIONS: In VLBW infants, early PICC removal at an enteral feed volume of 100 mL/kg/day compared with later removal at 140 mL/kg/day resulted in a significant delay in time to regain birth weight, and this delay was more pronounced in infants <1000 g.

Effect of Needle Aspiration of Pneumothorax on Subsequent Chest Drain Insertion in Newborns: A Randomized Clinical Trial.

Importance: Treatment options for a symptomatic pneumothorax in newborns include needle aspiration (NA) and chest drain (CD) insertion. There is little consensus as to the preferred treatment, reflecting a lack of evidence from clinical trials. Objective: To investigate whether treating pneumothoraces diagnosed on chest radiography (CR) in newborns receiving respiratory support with NA results in fewer infants having CDs inserted within 6 hours of diagnosis. Design, Setting, and Participants: This randomized clinical trial was conducted from October 7, 2013, to December 21, 2016. The setting was 5 tertiary European neonatal intensive care units. Infants receiving respiratory support (endotracheal ventilation, continuous positive airway pressure, or supplemental oxygen >40%) who had a pneumothorax on CR that clinicians deemed needed treatment were eligible for inclusion. Interventions: Infants were randomly assigned (1:1) to drainage using NA or CD insertion, stratified by center and gestation at birth (<32 vs ≥32 weeks). Caregivers were not masked to group assignment. For NA, a needle was inserted between the ribs to aspirate air and was removed once air was no longer aspirated. A CD was inserted if clinicians deemed that the response was inadequate. For CD insertion, a drain was inserted between the ribs and was left in situ. Main Outcomes and Measures: The primary outcome was whether a CD was inserted on the side of the pneumothorax within 6 hours of diagnosis. Results: A total of 76 infants were randomly assigned, and 6 (4 assigned to NA and 2 to CD) were excluded because they met exclusion criteria at enrollment. Of the 70 remaining infants, 33 (16 male [48%]) were assigned to NA and 37 (22 male [59%]) to CD insertion. Their median (interquartile range [IQR]) gestational age was 31 (27-38) vs 31 (27-35) weeks, and their median (IQR) birth weight was 1385 (1110-3365) vs 1690 (1060-2025) g, respectively. Fewer infants assigned to NA had a CD inserted within 6 hours (55% [18 of 33] vs 100% [37 of 37]; relative risk, 0.55; 95% CI, 0.40-0.75) and during hospitalization (70% [23 of 33] vs 100% [37 of 37]; relative risk, 0.70, 95% CI, 0.56-0.87). Conclusions and Relevance: Needle aspiration reduced the rate of CD insertion in symptomatic newborns with pneumothorax on CR. It should be used as the initial method of draining radiologically confirmed pneumothorax in symptomatic infants. Trial Registration: isrctn.org Identifier: ISRCTN65161530.

Positioning newborns on their back or right side for umbilical venous catheter insertion.

AIM: Newborns are placed supine for umbilical venous catheter insertion, and catheter tip position is confirmed with X-ray. Umbilical venous catheters are considered correctly positioned when the tip is in the inferior vena cava; however, frequently, the catheter tip enters the portal venous circulation. We wished to determine whether placing infants on their right side, rather than on the back, for umbilical venous catheter insertion results in more correctly placed catheters. METHODS: Newborns were randomised to be placed on their back, or turned onto their right side for catheter insertion. Primary outcome was correct catheter tip position on X-ray (visible in the midline at diaphragm level). RESULTS: Umbilical venous catheter insertion was successful in all infants enrolled. There was no difference in the proportion of correctly positioned catheters between the groups [back 23/44 (52%) versus right side 27/44 (61%), p = 0.389]. More infants randomised to back had the catheter tip in the portal circulation [back 13/44 (30%) versus right side 5/44 (11%), p = 0.034]. CONCLUSION: Positioning newborn infants on their right side did not result in more correctly placed umbilical venous catheters. The procedure was well tolerated and reduced the rate of tip insertion into the portal venous circulation.