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Children are considered a vulnerable population and have traditionally been excluded from research studies. This exclusion of children in general, and neonates in particular, from clinical research hampers the development of safe and effective therapies in this population. However, research involving children (including infants) is essential to guide therapy and optimize care. Neonatal research is complex, time intensive, difficult and expensive to conduct, and raises some unique ethical considerations. The complexity of research in this population is highlighted by the fear of causing harm to fragile sick infants which has led to the creation of special regulations on the degree of risk exposure permissible in research involving infants. This is further compounded by the inability of infants to provide informed consent or assent and the reliance on obtaining surrogate consent from parents who may themselves be vulnerable and overwhelmed by their infant's illness and the amount of information provided to them. In this review, we discuss the evolution of ethical regulations related to research, the justification for research in infants, and some of the ethical nuances of research in this population.
The aim of this quality improvement project was to reduce the rate of severe intraventricular hemorrhage (sIVH) by 50% within 3 years for extremely preterm infants born at a children's teaching hospital.
A multidisciplinary team developed key drivers for the development of intraventricular hemorrhage in preterm infants. Targeted interventions included the development of potentially better practice guidelines, promoting early noninvasive ventilation, consistent use of rescue antenatal betamethasone, and risk-based indomethacin prophylaxis. The outcome measure was the rate of sIVH. Process measures included the rate of intubation within 24 hours and receipt of rescue betamethasone and risk-based indomethacin prophylaxis. Common markers of morbidity were balancing measures. Data were collected from a quarterly chart review and analyzed with statistical process control charts. The preintervention period was from January 2012 to March 2016, implementation period was from April 2016 to December 2018, and sustained reduction in sIVH in extremely preterm infants.
Achievement of independent oral feedings remains the most common barrier to discharge in preterm infants. Early oral feeding initiation may be associated with a lower postmenstrual age (PMA) at independent oral feeding and discharge. In preterm infants born between 25 and 32 weeks' gestation, our aim was to decrease the PMA at independent oral feedings and discharge by 1 week between June 2019 and June 2020.
Following formation of a multidisciplinary team, the following plan-do-study-act cycles were targeted (1) oral feeding initiation at <33 weeks' PMA, (2) cue-based feeding, and (3) practitioner-driven feeding in infants who had not yet achieved independent oral feedings by 36 weeks' PMA. Outcome measures included the PMA at independent oral feeding and discharge. Process measures included adherence to cue-based feeding assessments and PMA at oral feeding initiation.
In total, 552 infants with a median gestational age of 30.3 weeks' (interquartile range 28.1-32.0) and birth weight of 1320 g (interquartile range 1019-1620) were included. The PMA at discharge decreased from 38.8 to 37.7 weeks during the first plan-do-study-act cycle, which coincided with an increase in the number of infants initiated on oral feeds at <33 weeks' PMA from 47% to 80%. The age at independent oral feeding decreased from 37.4 to 36.5 weeks' PMA.
In preterm infants born between 25 and 32 weeks' gestation, earlier oral feeding initiation was associated with a decreased PMA at independent oral feeding and discharge.
In preterm infants born between 25 and 32 weeks' gestation, earlier oral feeding initiation was associated with a decreased PMA at independent oral feeding and discharge.
To characterize the outcomes of ABO incompatible direct antiglobulin test (DAT) positive newborns and determine the predictive ability of a sixth-hour transcutaneous bilirubin (TcB for needing phototherapy ≤24 hours of age.
Retrospective, cross-sectional study from May 2013 to March 2017. Of 10 942 consecutive newborns ≥35 weeks estimated gestational age, 829 were ABO incompatible and DAT positive. After excluding for antibodies other than ABO (51), missing data (4), miscategorization of blood type O (1), and duplicate record (1), 772 newborns remained. Of 772, a subsample of 346 newborns with both TcB and total serum bilirubin (TSB) tests within 1 hour of the sixth hour was analyzed to determine the predictive ability.
Phototherapy was required in 281 of 772 (36.4%); 156 (20.2%) in the first 24 hours. There were 10 (1.3%) admissions for hyperbilirubinemia to the NICU for intravenous immunoglobin. Birth weight, infant blood type B, TSB, reticulocyte count, and TcB were all significantly associated with phototherapy ≤24 hours. On multivariate analysis, significant predictors of phototherapy ≤24 hours were TSB and reticulocyte count if no TcB was done and TcB alone if no blood tests were done. TcB was highly predictive (odds ratio 3.1, 95% confidence interval 2.4-4.0) and nearly as accurate as the TSB and reticulocyte count (area under the curve, 0.90 and 0.96, respectively). Low (<3.0 mg/dL) and high (≥5.3 mg/dL) risk TcB cutoffs demonstrated a negative predictive value of 98% and positive predictive value of 85%, respectively.
Among high-risk ABO incompatible DAT positive newborns, the sixth-hour TcB is highly predictive of the need for phototherapy ≤24 hours.
Among high-risk ABO incompatible DAT positive newborns, the sixth-hour TcB is highly predictive of the need for phototherapy ≤24 hours.
The pediatric emergency department (ED)-based Pediatric Septic Shock Collaborative (PSSC) aimed to improve mortality and key care processes among children with presumed septic shock.
This was a multicenter learning and improvement collaborative of 19 pediatric EDs from November 2013 to May 2016 with shared screening and patient identification recommendations, bundles of care, and educational materials. Process metrics included minutes to initial vital sign assessment and to first and third fluid bolus and antibiotic administration. Outcomes included 3- and 30-day all-cause in-hospital mortality, hospital and ICU lengths of stay, hours on increased ventilation (including new and increases from chronic baseline in invasive and noninvasive ventilation), and hours on vasoactive agent support. Analysis used statistical process control charts and included both the overall sample and an ICU subgroup.
Process improvements were noted in timely vital sign assessment and receipt of antibiotics in the overall group. Timely first bolus and antibiotics improved in the ICU subgroup. There was a decrease in 30-day all-cause in-hospital mortality in the overall sample.
A multicenter pediatric ED improvement collaborative showed improvement in key processes for early sepsis management and demonstrated that a bundled quality improvement-focused approach to sepsis management can be effective in improving care.
A multicenter pediatric ED improvement collaborative showed improvement in key processes for early sepsis management and demonstrated that a bundled quality improvement-focused approach to sepsis management can be effective in improving care.Focused ultrasound (FUS) is a noninvasive therapeutic technology with multiple pediatric clinical applications. The ability of focused ultrasound to target tissues deep in the body without exposing children to the morbidities associated with conventional surgery, interventional procedures, or radiation offers significant advantages. In 2021, there are 10 clinical pediatric focused ultrasound studies evaluating various musculoskeletal, oncologic, neurologic, and vascular diseases of which 8 are actively recruiting and 2 are completed. Pediatric musculoskeletal applications of FUS include treatment of osteoid osteoma and bone metastases using thermal ablation and high-intensity FUS. Pediatric oncologic applications of FUS include treatment of soft tissue tumors including desmoid tumors, malignant sarcomas, and neuroblastoma with high-intensity FUS ablation alone, or in combination with targeted chemotherapy delivery. Pediatric neurologic applications include treatment of benign tumors such as hypothalamic hamartomas with thermal ablation and malignant diffuse intrinsic pontine glioma with low-intensity FUS for blood brain barrier opening and targeted drug delivery. Additionally, low-intensity FUS can be used to treat seizures. Pediatric vascular applications of FUS include treatment of arteriovenous malformations and twin-twin transfusion syndrome using ablation and vascular occlusion. FUS treatment appears safe and efficacious in pediatric populations across many subspecialties. Although there are 7 Food and Drug Administration-approved indications for adult applications of FUS, the first Food and Drug Administration approval for pediatric patients with osteoid osteoma was obtained in 2020. This review summarizes the preclinical and clinical research on focused ultrasound of potential benefit to pediatric populations.
Cefazolin, a first-generation cephalosporin, is the most commonly recommended antibiotic for perioperative prophylaxis to reduce surgical site infections. Children with a reported penicillin allergy often receive an alternative antibiotic because of a common misunderstanding of the cross-reactivity between these antibiotics. This use of alternative antibiotics in surgical populations have been associated with increased infections, antibiotic resistance, and health care costs. We aimed to increase the percentage of patients with nonsevere penicillin-class allergies who receive cefazolin for antibiotic prophylaxis.
A multidisciplinary team conducted this quality improvement initiative, with a series of 3 plan-do-study-act cycles aimed at children with nonsevere penicillin-class allergies undergoing surgical procedures that require antibiotic prophylaxis. Bozitinib mw The primary outcome measure was the percentage of surgical encounters among patients with nonsevere penicillin-class allergies who received cefazolin as antibiotic prophylaxis. Statistical process control charts were used to measure improvement over time.
Approximately 400 children were involved in this project. There was special cause variation and a shift in the center line from 60% to 80% of eligible patients receiving cefazolin for antibiotic prophylaxis, which was sustained for the duration of the project. In the last month, 90% of eligible patient received cefazolin, surpassing our goal of 85%. This improvement has been sustained in the 5 months after project completion. We had no cases of severe allergic reactions in the operating room.
Our multidisciplinary education-focused interventions were associated with a significant increase in the use of cefazolin for perioperative antibiotic prophylaxis in patient with penicillin allergies.
Our multidisciplinary education-focused interventions were associated with a significant increase in the use of cefazolin for perioperative antibiotic prophylaxis in patient with penicillin allergies.
