From vacant to vivid: The nutritional landscape drives infant gut microbiota establishment.

From the moment of birth, the newborn gastrointestinal tract is infiltrated by various bacteria originating from both maternal and environmental sources. These colonizing bacteria form a complex microbiota community that undergoes continuous changes until adulthood and plays an important role in infant health. The maturation of the infant gut microbiota is driven by many factors and follows a distinct patterned trajectory, with specific bacterial taxa establish in the intestine in accordance with developmental milestones as the infant grows. In this review, we highlight how elements such as diet and host physiology select for specific microbial functions and shape the composition of the bacterial community in the large intestine.

"It's hard to wait": Provider perspectives on current genomic care in safety-net NICUs.

PURPOSE: Critically ill infants from marginalized populations disproportionately receive care in neonatal intensive care units (NICUs) that lack access to state-of-the-art genomic care, leading to inequitable outcomes. We sought provider perspectives to inform our implementation study (VIGOR) providing rapid genomic sequencing within these settings. METHODS: We conducted semistructured focus groups with neonatal and genetics providers at 6 NICUs at safety-net hospitals, informed by the Promoting Action on Research Implementation in Health Services framework, which incorporates evidence, context, and facilitation domains. We iteratively developed codes and themes until thematic saturation was reached. RESULTS: Regarding evidence, providers felt that genetic testing benefits infants and families. Regarding context, the major barriers identified to genomic care were genetic testing cost, lack of genetics expertise for disclosure and follow-up, and navigating the complexity of selecting and ordering genetic tests. Providers had negative feelings about the current status quo and inequity in genomic care across NICUs. Regarding facilitation, providers felt that a virtual support model such as VIGOR would address major barriers and foster family-centered care and collaboration. CONCLUSION: NICU providers at safety-net hospitals believe that access to state-of-the-art genomic care is critical for optimizing infant outcomes; yet, substantial barriers exist that the VIGOR study may address.

Nine is the New Ten of Apgar Scores: An Observational Retrospective Cohort Study.

Apgar scores of 10 were once common but are now rare. We aggregated scores from US term infants from 1978 to 2021. We found that scores of 10 decreased by logarithmic decay independent of demographic changes. We hypothesize that this trend was driven by improved appreciation of transitional physiology.

The Landscape of Resource Utilization After Resuscitation of 22-, 23-, and 24-Weeks' Gestation Infants.

OBJECTIVE: To compare estimated healthcare resources needed to care for 22 through 24 weeks' gestation infants. STUDY DESIGN: This multicenter, retrospective cohort study included 1505 live in-born and out-born infants 22 through 24 weeks' gestational age at delivery from 6 pediatric tertiary care hospitals from 2011 through 2020. Median neonatal intensive care unit (NICU) length of stay (LOS) for each gestational age was used as a proxy for hospital resource utilization, and the number of comorbidities and medical technology use for each infant were used as estimates of future medical care needs. Data were analyzed using Kruskal-Wallis with Nemenyi's posthoc test and Fisher's exact test. RESULTS: Of the identified newborns, 22-week infants had shorter median LOS than their 23- and 24-week counterparts due to low survival rates. There was no significant difference in LOS for surviving 22-week infants compared with surviving 23-week infants. Surviving 22-week infants had similar proportions of comorbidities and medical technology use as 23-week infants. CONCLUSIONS: Compared with 23- and 24-week infants, 22-week infants did not use a disproportionate amount of hospital resources. Twenty-two-week infants should not be excluded from resuscitation based on concern for increased hospital care and medical technology requirements. As overall resuscitation efforts and survival rates increase for 22-week infants, future research will be needed to assess the evolution of these results.

Hyperpolarized 13C magnetic resonance imaging in neonatal hypoxic-ischemic encephalopathy: First investigations in a large animal model.

Early biomarkers of cerebral damage are essential for accurate prognosis, timely intervention, and evaluation of new treatment modalities in newborn infants with hypoxia and ischemia at birth. Hyperpolarized 13C magnetic resonance imaging (MRI) is a novel method with which to quantify metabolism in vivo with unprecedented sensitivity. We aimed to investigate the applicability of hyperpolarized 13C MRI in a newborn piglet model and whether this method may identify early changes in cerebral metabolism after a standardized hypoxic-ischemic (HI) insult. Six piglets were anesthetized and subjected to a standardized HI insult. Imaging was performed prior to and 2 h after the insult on a 3-T MR scanner. For 13C studies, [1-13C]pyruvate was hyperpolarized in a commercial polarizer. Following intravenous injection, images were acquired using metabolic-specific imaging. HI resulted in a metabolic shift with a decrease in pyruvate to bicarbonate metabolism and an increase in pyruvate to lactate metabolism (lactate/bicarbonate ratio, mean [SD]; 2.28 [0.36] vs. 3.96 [0.91]). This is the first study to show that hyperpolarized 13C MRI can be used in newborn piglets and applied to evaluate early changes in cerebral metabolism after an HI insult.

Impact of restrictive platelet transfusion strategies on transfusion rates: A cohort study in very preterm infants.

BACKGROUND: Evidence supports a restrictive platelet transfusion threshold in preterm neonates. We aimed to describe the effect of implementing this threshold on transfusion rates. STUDY DESIGN AND METHODS: This retrospective observational cohort study included all very preterm infants (born <32 weeks' gestation) admitted to a neonatal intensive care unit between 2004 and 2022, divided into three epochs. Platelet transfusion thresholds changed from 30 × 109/L for stable neonates and 50 × 109/L for unstable neonates (January 2004 to December 2009) to 20 × 109/L for stable neonates and 50 × 109/L for unstable neonates (January 2010 to June 2019) to 25 × 109/L for non-bleeding neonates and 50 × 109/L for neonates with major bleeding (July 2019 to July 2022). The primary outcome was the percentage of transfused neonates in each epoch. Secondary outcomes included the median number of transfusions per neonate, the percentage of transfusions given above 25 or 50 × 109/L, and major bleeding and mortality rates. RESULTS: The percentage of neonates transfused was 12.2% (115/939), 5.8% (96/1660), and 4.8% (25/525) in Epoch I, II, and III, respectively (p < .001), a relative reduction of 61%. The median number of transfusions per transfused neonate was 2.0 (interquartile range [IQR]: 1.0-3.0) in Epoch I, and 1.0 (IQR: 1.0-2.0) in subsequent Epochs (p = .04). The percentage of infants receiving at least one transfusion above 50 × 109/L in Epoch I, II, and III was 51.3% (59/115), 17.7% (17/96), and 20.0% (5/25; p < .001). Mortality and bleeding rates did not significantly differ between epochs. DISCUSSION: Implementation of restrictive platelet guidelines led to reduction of the rate and number of platelet transfusions.

Improving genetic testing utilization in a tertiary care neonatal intensive care unit through quality improvement.

There is an increasing recognition of the importance of diagnosing genetic conditions with an ever-growing list of genetic testing options. However, most providers do not have formal genetics training, which makes choosing the most appropriate test to order challenging. Our project sought to improve cytogenetic testing utilization in a tertiary care neonatal intensive care unit (NICU) through utilizing quality improvement techniques, specifically the Model for Improvement framework with rapid Plan-Do-Study-Act cycles. Our project utilized various interventions including the implementation of a NICU genetic testing algorithm. Interventions demonstrated improvement in all areas, specifically a 92% reduction in unnecessary cytogenetic testing with improvement in the diagnostic rate. Our work also resulted in a 59% decrease in charges with an estimated projected savings of $21,000 per year. Quality improvement can minimize redundancies and inefficiencies in genetic testing in a Level IV NICU in a large tertiary care children's hospital and result in substantial cost-savings.

Coagulation profiles and percentiles in neonates with hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia: A step toward more accurate transfusion thresholds.

BACKGROUND: In the literature, there are no studies about the transfusion threshold for neonates with hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia (TH). In order to facilitate accurate interpretation of coagulation results in these neonates, we aimed to generate specific reference intervals in this specific population. METHODS: This retrospective study included all HIE neonates admitted from 2014 to 2022 to undergo TH. All infants during TH underwent blood exams, including the coagulation profile. Our primary outcome was to assess the estimates of the 3rd, 10th, 25th, 50th, 75th, 90th, and 97th percentiles for each parameter on admission (before transfusion). By the receiver operating characteristic (ROC) analysis, the area under the ROC curve (AUC) and the best cut-off point were used to evaluate the ability of the prothrombin time expressed as international normalized ratio (PT-INR) to predict the risk of any bleeding. RESULTS: A total of 143 infants were included in this study. On admission, the median fibrinogen value was 205 mg/dL, prothrombin time 18.6 seconds, PT-INR 1.50, activated partial thromboplastin time 38.3 seconds, thrombin time 18.6 seconds, antithrombin 57.0%. The optimal cut-off of PT-INR in predicting the risk of any bleeding was greater than 1.84 (AUC .623, p = .024). CONCLUSION: For the first time, we proposed the percentiles of coagulation parameters in our cohort of neonates with HIE. Furthermore, we found that a PT-INR greater than 1.84 can significantly predict the risk of any bleeding. Further studies are needed to determine if a restrictive versus a liberal transfusion approach can be equally safer for these high-risk infants.

Nirsevimab: Expansion of Respiratory Syncytial Virus Prevention Options in Neonates, Infants, and At-Risk Young Children.

OBJECTIVE: Review available data from clinical trials of nirsevimab for efficacy and safety in the setting of respiratory syncytial virus (RSV) prophylaxis in infants and children, while exploring nirsevimab's role in clinical practice and highlighting continuing questions. DATA SOURCES: A literature search of PubMed was conducted utilizing the phrases "nirsevimab" and "medi8897." Additional references were identified through found references. Organizational guidelines, medication labeling, and regulatory organization presentations were utilized. STUDY SELECTION AND DATA EXTRACTION: Relevant clinical trials investigating nirsevimab in infants and children were included as well as other references on pharmacology, pharmacokinetics, and pharmacoeconomics. DATA SYNTHESIS: Nirsevimab, a once-a-season monoclonal antibody, demonstrated a 79.5% (95% CI, 65.9-87.7; P < 0.00001) lower incidence of RSV-associated medically attended lower respiratory tract infections (MA RSV-associated LRTI) and 77.3% (95% CI, 50.3-89.7; P = 0.0002) reduction in hospitalizations for RSV-associated MA-LRTI across 2 placebo-controlled studies. Nirsevimab demonstrated comparable safety to placebo with minor dermatologic reactions being the most common adverse event (0.9% vs 0.6%). RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON WITH EXISTING AGENTS: Nirsevimab was approved by the US Food and Drug Administration, and recommended by the Advisory Committee on Immunization Practices and American Academy of Pediatrics for broad administration to infants entering their first RSV season and at risk patients during their second RSV season. Questions remain over efficacy in infants born < 29-week gestation and other economical considerations. CONCLUSIONS: Nirsevimab demonstrated clinical efficacy in reducing RSV-associated MA-LRTI and RSV-associated hospitalizations in infants and was well tolerated.

A Proof-of-Concept Model for Implementing a "Smart-NICU" to Improve Infant Mortality.

Low- and middle-income countries face limited critical care capacity due to constraints in staffing, resources, and technology. "Smart ICUs" that integrate telehealth to augment care delivery, communication, and data integration have the potential to bridge these gaps and reduce preventable morbidity and mortality. While their efficacy has been well validated in adult populations, applications of Smart-ICU services in the neonatal population have not been studied. Neonatal intensive care units (NICUs) in India using a common Smart-NICU platform, developed by CloudPhysician, utilize a hub-and-spokes framework along with locally designed technology to facilitate remote patient care in collaboration with local health systems. In this article, we investigate the operational characteristics and performance outcomes for Smart-NICU deployment from the 18 NICUs and 214 beds deployed to date. These findings highlight the potential impact of Smart-NICUs and establish generalizable principles for implementation in low-resource settings.

Syndecan-1 Level, a Marker of Endothelial Glycocalyx Degradation, Is Associated With Fetal Exposure to Chorioamnionitis and Is a Potential Biomarker for Early-Onset Neonatal Sepsis.

The goal of this investigation was to identify the association between Syndecan-1 (S1) serum levels in preterm newborns exposed to chorioamnionitis (CA) in utero and the potential of S1 as a biomarker of early-onset neonatal sepsis. A cohort of preterm newborns born <33 weeks gestational age was recruited. Within 48 hours of birth, 0.5 mL of blood was drawn to obtain S1 levels, measured via ELISA. Placentas were examined and classified as having (1) no CA, (2) CA without umbilical cord involvement, or (3) CA with inflammation of the umbilical cord (funisitis). S1 levels were compared between preterm newborns without exposure to CA verus newborns with exposure to CA (including with and without funisitis). Preterm newborns exposed to CA were found to have significantly elevated S1 levels compared to those unexposed. Although S1 levels could not differentiate fetal exposure to CA from exposure to CA with funisitis, the combined CA groups had significantly higher S1 levels compared to those not exposed to CA. S1 level has the potential to become a clinically useful biomarker that could assist in the management of mothers and preterm newborns with CA and funisitis. Furthermore, S1 level could aid in the diagnosis and treatment of early-onset neonatal sepsis.

The influence of chorioamnionitis on respiratory drive and spontaneous breathing of premature infants at birth: a narrative review.

Most very premature infants breathe at birth but require respiratory support in order to stimulate and support their breathing. A significant proportion of premature infants are affected by chorioamnionitis, defined as an umbrella term for antenatal inflammation of the foetal membranes and umbilical vessels. Chorioamnionitis produces inflammatory mediators that potentially depress the respiratory drive generated in the brainstem. Such respiratory depression could maintain itself by delaying lung aeration, hampering respiratory support at birth and putting infants at risk of hypoxic injury. This inflammatory-mediated respiratory depression may contribute to an association between chorioamnionitis and increased requirement of neonatal resuscitation in premature infants at birth. This narrative review summarises mechanisms on how respiratory drive and spontaneous breathing could be influenced by chorioamnionitis and provides possible interventions to stimulate spontaneous breathing.  Conclusion: Chorioamnionitis could possibly depress respiratory drive and spontaneous breathing in premature infants at birth. Interventions to stimulate spontaneous breathing could therefore be valuable. What is Known: • A large proportion of premature infants are affected by chorioamnionitis, antenatal inflammation of the foetal membranes and umbilical vessels. What is New: • Premature infants affected by chorioamnionitis might be exposed to higher concentrations of respiratory drive inhibitors which could depress breathing at birth. • Premature infants affected by chorioamnionitis seem to be associated with a higher and more extensive requirement of resuscitation at birth.

Our estimates of neonatal radiation exposure fall short of reality.

The purpose of this study is to evaluate radiation exposure in newborns undergoing imaging tests during the first 30 days of neonatal intensive care unit (NICU) hospitalization. A retrospective cohort study was conducted from November 2018 to April 2019 with newborns admitted to the NICU. Thermoluminescent dosimeters (TLD-100™) measured radiation emitted during imaging exams over 1 month, with a comparison between measured and estimated radiation. The cohort exhibited a median gestational age of 33.0 (31.0, 37.0) weeks, a median birth weight of 1840 (1272, 2748) g, and a median length of stay of 25.5 (11.7, 55.0) days. Eighty-four patients underwent 314 imaging tests, with an estimated radiation dose (ERD) per patient of 0.116 mSv and a measured radiation dose (MDR) of 0.158 mSv. ERD consistently underestimated MDR, with a mean difference of -0.043 mSv (-0.049 to -0.036) in the Bland-Altman analysis. The regression equation was as follows: difference MRD - ERD = -1.7 × (mean (MRD + ERD)) + 0.056. The mean estimated radiation dose per exam was 0.030 mSv, and the chest X-rays accounted for 63.26% of total exams. The median number of radiographic incidences per patient was 2 (1, 4), with 5 patients undergoing three or more exams in a single day. CONCLUSION: Radiation exposure in these newborns was underestimated, emphasizing the need for awareness regarding associated risks and strict criteria for requesting radiological exams. Lung ultrasound is a radiation-free and effective option in managing respiratory diseases in newborns, reducing the reliance on chest X-rays. WHAT IS KNOWN: • Radiation used in diagnostic exams is not risk-free. • Radiation risk is much higher in small Infants due to the exposure area and the prolonged expectance of life. WHAT IS NEW: • Radiation exposure is underestimated in the neonatal population. • The study found a mean radiation exposure in neonates about 5% of the mean annual dose in the general population.

Intrapartum maternal glycaemic control for the prevention of neonatal hypoglycaemia: a systematic review and meta-analysis.

BACKGROUND: Neonatal hypoglycaemia is the most common metabolic disorder in infants, and may be influenced by maternal glycaemic control. This systematic review evaluated the effect of intrapartum maternal glycaemic control on neonatal hypoglycaemia. METHODS: We included randomised controlled trials (RCTs), quasi-RCTs, non-randomised studies of interventions, and cohort or case-control studies that examined interventions affecting intrapartum maternal glycaemic control compared to no or less stringent control. We searched four databases and three trial registries to November 2023. Quality assessments used Cochrane Risk of Bias 1 or the Effective Public Health Practice Project Quality Assessment Tool. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Meta-analysis was performed using random-effects models analysed separately for women with or without diabetes. The review was registered prospectively on PROSPERO (CRD42022364876). RESULTS: We included 46 studies of women with diabetes and five studies of women without diabetes: one RCT, 32 cohort and 18 case-control studies (11,273 participants). For women with diabetes, the RCT showed little to no difference in the incidence of neonatal hypoglycaemia between tight versus less tight intrapartum glycaemic control groups (76 infants, RR 1.00 (0.45, 2.24), p = 1.00, low certainty evidence). However, 11 cohort studies showed tight intrapartum glycaemic control may reduce neonatal hypoglycaemia (6,152 infants, OR 0.44 (0.31, 0.63), p < 0.00001, I2 = 58%, very low certainty evidence). For women without diabetes, there was insufficient evidence to determine the effect of tight intrapartum glycaemic control on neonatal hypoglycaemia. CONCLUSIONS: Very uncertain evidence suggests that tight intrapartum glycaemic control may reduce neonatal hypoglycaemia in infants of women with diabetes. High-quality RCTs are required.

Neonatal and maternal outcomes at early vs. full term following induction of labor; A secondary analysis of the OBLIGE randomized trial.

INTRODUCTION: Birth at early term (37+0-38+6 completed gestational weeks [GW] and additional days) is associated with adverse neonatal outcomes compared with waiting to ≥39 GW. Most studies report outcomes after elective cesarean section or a mix of all modes of births; it is unclear whether these adverse outcomes apply to early-term babies born after induction of labor (IOL). We aimed to determine, in women with a non-urgent induction indication (elective/planned >48 h in advance), if IOL at early and late term was associated with adverse neonatal and maternal outcomes compared with IOL at full term. MATERIAL AND METHODS: An observational cohort study as a secondary analysis of a multicenter randomized controlled trial of 1087 New Zealand women with a planned IOL ≥37+0 GW. Multivariable logistic regression was used to analyze neonatal and maternal outcomes in relation to gestational age; 37+0-38+6 (early term), 39+0-40+6 (full term) and ≥41+0 (late term) GW. Neonatal outcome analyses were adjusted for sex, birthweight, mode of birth and induction indication, and maternal outcome analyses for parity, age, body mass index and induction method. The primary neonatal outcome was admission to neonatal intensive care unit (NICU) for >4 hours; the primary maternal outcome was cesarean section. RESULTS: Among the 1087 participants, 266 had IOL at early term, 480 at full term, and 341 at late term. Babies born following IOL at early term had increased odds for NICU admission for >4 hours (adjusted odds ratio [aOR] 2.16, 95% confidence intervals (CI) 1.16-4.05), compared with full term. Women having IOL at early term had no difference in emergency cesarean rates but had an increased need for a second induction method (aOR 1.70, 95% CI 1.15-2.51) and spent 4 h longer from start of IOL to birth (Hodges-Lehmann estimator 4.10, 95% CI 1.33-6.95) compared with those with IOL at full term. CONCLUSIONS: IOL for a non-urgent indication at early term was associated with adverse neonatal and maternal outcomes and no benefits compared with IOL at full term. These findings support international guidelines to avoid IOL before 39 GW unless there is an evidence-based indication for earlier planned birth and will help inform women and clinicians in their decision-making about timing of IOL.

Screening of substance use in pregnancy: A Danish cross-sectional study.

INTRODUCTION: There is a paucity of objectively verified data on substance use among Danish pregnant women. We estimated the prevalence of substance use including alcohol and nicotine among the general population of Danish pregnant women. MATERIAL AND METHODS: In this anonymous, national, cross-sectional, descriptive study, pregnant women were invited when attending an ultrasound scan between November 2019 and December 2020 at nine Danish hospitals. Women submitted a urine sample and filled out a questionnaire. Urine samples were screened on-site with a qualitative urine dipstick for 15 substances including alcohol, nicotine, opioids, amphetamines, cannabis, and benzodiazepines. All screen-positive urine samples underwent secondary quantitative analyses with gold standard, liquid chromatography-tandem mass spectrometry (LC-MS/MS) analysis. Results were compared to questionnaire information to analyze the validity of self-reporting and to examine possible cross-reactions. RESULTS: A total of 1903 of 2154 invited pregnant women participated (88.3%). The prevalence of dipstick-positive urine samples was 25.0%. 44.0% of these were confirmed positive, resulting in a total confirmed prevalence of 10.8%. The prevalence of nicotine use was 10.1%-and for all other substances, <0.5%. Nicotine use was more prevalent among younger pregnant women, while other substance use appeared evenly distributed over age groups. Self-reporting of use of nicotine products was high (71.1%), but low for cannabis and alcohol intake (0% and 33.3%, respectively). Prescription medication explained almost all cases of oxycodone, methylphenidate, and benzodiazepine use. CONCLUSIONS: Substance use among pregnant women consisted mainly of nicotine. Dipstick screening involved risks of false negatives and false positives. Except for alcohol intake and cannabis use, dipstick analyses did not seem to provide further information than self-reporting. LC-MS/MS analyses remain gold standard, and future role of dipstick screenings should be discussed.

The current clinical landscape of neonatal respiratory failure in Jiangsu Province of China: patient demographics, NICU treatment interventions, and patient outcomes.

INTRODUCTION: Neonatal respiratory failure (NRF) is a serious condition that often has high mortality and morbidity, effective interventions can be delivered in the future by identifying the risk factors associated with morbidity and mortality. However, recent advances in respiratory support have improved neonatal intensive care units (NICUs) care in China. We aimed to provide an updated review of the clinical profile and outcomes of NRF in the Jiangsu province. METHODS: Infants treated for NRF in the NICUs of 28 hospitals between March 2019 and March 2022 were retrospectively reviewed. Data collected included baseline perinatal and neonatal parameters, NICU admission- and treatment-related data, and patient outcomes in terms of mortality, major morbidity, and survival without major morbidities. RESULTS: A total of 5548 infants with NRF were included in the study. The most common primary respiratory disorder was respiratory distress syndrome (78.5%). NRF was managed with non-invasive and invasive respiratory support in 59.8% and 14.5% of patients, respectively. The application rate of surfactant therapy was 38.5%, while that of neonatal extracorporeal membrane oxygenation therapy was 0.2%. Mortality and major morbidity rates of 8.5% and 23.2% were observed, respectively. Congenital anomalies, hypoxic-ischemic encephalopathy, invasive respiratory support only and inhaled nitric oxide therapy were found to be significantly associated with the risk of death. Among surviving infants born at < 32 weeks of gestation or with a birth weight < 1500 g, caffeine therapy and repeat mechanical ventilation were demonstrated to significantly associate with increased major morbidity risk. CONCLUSION: Our study demonstrates the current clinical landscape of infants with NRF treated in the NICU, and, by proxy, highlights the ongoing advancements in the field of perinatal and neonatal intensive care in China.

Music therapy in tertiary neonatal intensive care: A matter of unlikely allies?

Over the past decades, music therapy in the neonatal intensive care unit (NICU) has been proven effective in physiological and psychological outcomes, including sucking, behaviour, stress reduction, neurodevelopment and promoting emotional bonding. However, not every NICU administers music therapy in their ward. Research on music therapy for neonates and their caregivers has lately accumulated, increasing the evidence of health benefits on brain development and across a variety of NICU-related pathologies, including neurological, cardiological, pulmonary and gastrointestinal problems. Conclusively, we will present the studied methods of music therapy for clinical benefits in neonatal intensive care.

Practical approaches for supporting informed consent in neonatal clinical trials.

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.

Mortality in the neonatal intensive care setting: Do benchmarks tell the whole story?

AIM: Australian neonatal mortality data are collected and shared within collaborative networks. Individual unit outcomes are benchmarked between units and presented in quarterly or yearly reports. Low mortality is commonly interpreted as optimal performance. However, current collected data do not differentiate between death due to severe illness and death following treatment limitation. This study aims to explore the physiological condition immediately before death, and the proportion of deaths attributed to treatment limitation. METHODS: This retrospective single centre study of 100 consecutive deaths classified the physiological condition 12 h prior to death as stable or unstable using a clinical illness score based upon pH, oxygen saturation index, medications and blood product use. Documented discussions regarding expected outcomes and goals of management were reviewed for agreed upon treatment limitations and analysed against physiological stability. RESULTS: Causes of death were sepsis (n = 24), congenital anomalies (n = 20), extreme prematurity (n = 19), hypoxic ischaemic encephalopathy (n = 18), intraventricular haemorrhage (n = 11) and other (n = 8). Forty-eight infants were physiologically stable at 12 h before death. In infants classified as physiologically stable, 90% of deaths were in a scenario where palliative care was discussed and intensive care treatment was ceased. These deaths accounted for 43% of total mortality in our unit. CONCLUSION: A large portion of mortality in our unit could be attributed to treatment limitations in physiologically stable infants with high risk of neurodevelopmental impairment. Our study emphasises the need to consider the physiological status around time of death for optimal benchmarking of mortality between neonatal units.