Video-Assisted Informed Consent in a Clinical Trial of Resuscitation of Extremely Preterm Infants: Lessons Learned.

OBJECTIVE: Obtaining informed consent for clinical trials is challenging in acute clinical settings. For the VentFirst randomized clinical trial (assisting ventilation during delayed cord clamping for infants <29 weeks' gestation), we created an informational video that sites could choose to use to supplement the standard in-person verbal and written consent. Using a postconsent survey, we sought to describe the impact of the video on patient recruitment, satisfaction with the consent process, and knowledge about the study. STUDY DESIGN: This is a descriptive survey-based substudy. RESULTS: Of the sites participating in the VentFirst trial that obtained institutional review board (IRB) approval to allow use of the video to supplement the standard informed consent process, three elected to participate in the survey substudy. From February 2018 to January 2021, 82 women at these three sites were offered the video and completed the postconsent survey. Overall, 73 of these 82 women (89%) consented to participate in the primary study, 78 (95%) indicated the study was explained to them very well or extremely well, and the range of correct answers on five knowledge questions about the study was 63 to 98%. Forty-six (56%) of the 82 women offered the video chose to watch it. There were no major differences in study participation, satisfaction with the consent process, or knowledge about the study between the women who chose to watch or not watch the video. CONCLUSION: Watching an optional video to supplement the standard informed consent process did not have a major impact on outcomes in this small substudy. The ways in which audiovisual tools might modify the traditional informed consent process deserve further study. KEY POINTS: · Informed consent in acute clinical contexts is difficult.. · Videos offer an alternative communication tool.. · Continued research is necessary to optimize the consent process..

Cardiac Development and Related Clinical Considerations.

The anatomy, physiology, and hemodynamics of the premature heart vary along the range of gestational ages cared for in neonatal intensive care units, from 22 weeks to term gestation. Clinical management of the preterm neonate should account for this heterogenous development. This requires an understanding of the impact of ex utero stressors on immature and disorganized cardiac tissue, the different state of hemodynamics across intracardiac shunts impacting the natural transition from fetal to neonatal life, and the effects of intensive pharmacologic and non-pharmacologic interventions that have systemic consequences influencing cardiac function. This article provides a review of the increasing but still limited body of literature on the anatomy, hemodynamics, and electrophysiology of the preterm heart with relevant clinical considerations.

Meconium aspiration syndrome: a comprehensive review.

Meconium aspiration syndrome (MAS) is a complex respiratory disease that continues to be associated with significant morbidities and mortality. The pathophysiological mechanisms of MAS include airway obstruction, local and systemic inflammation, surfactant inactivation and persistent pulmonary hypertension of the newborn (PPHN). Supplemental oxygen and non-invasive respiratory support are the main therapies for many patients. The management of the patients requiring invasive mechanical ventilation could be challenging because of the combination of atelectasis and air trapping. While studies have explored various ventilatory modalities, evidence to date does not clearly support any singular modality as superior. Patient's pathophysiology, symptom severity, and clinician/unit expertise should guide the respiratory management. Early identification and concomitant management of PPHN is critically important as it contributes significantly to mortality and morbidities.

Prenatal consults with illustrated literature (PnCIL): a RCT studying visual aids during prenatal consults.

OBJECTIVE: We hypothesize that addition of illustrated handouts during prenatal consultations decreases maternal anxiety and improves maternal knowledge. STUDY DESIGN: Inpatient gravid women at 25 0/7-34 6/7 weeks gestation were randomized to Standard or Illustrated consults, verbal consults supplemented with a visual handout. Post consult surveys were administered assessing maternal anxiety and knowledge acquisition. RESULT: We enrolled 82 women; 54 to Standard Consult, 28 to Illustrated Consult. Consult duration was the same across arms. Anxiety and knowledge were not impacted by the intervention overall. We found higher mean knowledge by 17% for consults ≥31 min (P = 0.006; 95% CI 0.67-3.82), and 13% in primigravids (P = 0.032; 95% CI 0.15-3.21) in the intervention arm. CONCLUSIONS: Using illustrated handouts is feasible and does not increase duration of prenatal consults. It may improve knowledge acquisition in long consults and in primigravida women, although it does not impact anxiety and knowledge overall.

Respiratory failure secondary to congenital pulmonary arterial thrombus with lung dysplasia.

Respiratory failure requiring extracorporeal membranous oxygenation in the newborn is commonly seen secondary to severe pathology such as congenital diaphragmatic hernia, meconium aspiration syndrome, pulmonary hypertension and pulmonary hypoplasia. However, atypical causes of respiratory failure, such as pulmonary arterial thrombi, are often refractory to traditional management and require careful multidisciplinary evaluation. We report a case of respiratory failure secondary to congenital pulmonary arterial thrombosis of unknown aetiology in an otherwise healthy neonate. We discuss the abnormal anatomy and pathophysiology that presented in our patient secondary to this condition and discuss our diagnostic process, management and outcomes. Additionally, we review the literature for reported cases and discuss current hypotheses on the development of congenital pulmonary arterial thrombi. Given the rare occurrence of this event, we hope to contribute to the understanding of future similar cases and emphasise the importance of keeping pulmonary arterial thrombi in the clinical differential.

Real-time Iontophoresis with Tetramethylammonium to Quantify Volume Fraction and Tortuosity of Brain Extracellular Space.

This review describes the basic concepts and protocol to perform the real-time iontophoresis (RTI) method, the gold-standard to explore and quantify the extracellular space (ECS) of the living brain. The ECS surrounds all brain cells and contains both interstitial fluid and extracellular matrix. The transport of many substances required for brain activity, including neurotransmitters, hormones, and nutrients, occurs by diffusion through the ECS. Changes in the volume and geometry of this space occur during normal brain processes, like sleep, and pathological conditions, like ischemia. However, the structure and regulation of brain ECS, particularly in diseased states, remains largely unexplored. The RTI method measures two physical parameters of living brain: volume fraction and tortuosity. Volume fraction is the proportion of tissue volume occupied by ECS. Tortuosity is a measure of the relative hindrance a substance encounters when diffusing through a brain region as compared to a medium with no obstructions. In RTI, an inert molecule is pulsed from a source microelectrode into the brain ECS. As molecules diffuse away from this source, the changing concentration of the ion is measured over time using an ion-selective microelectrode positioned roughly 100 µm away. From the resulting diffusion curve, both volume fraction and tortuosity can be calculated. This technique has been used in brain slices from multiple species (including humans) and in vivo to study acute and chronic changes to ECS. Unlike other methods, RTI can be used to examine both reversible and irreversible changes to the brain ECS in real time.