Evaluation of temperature excursions from USP <659> recommendations during mail transit.

BACKGROUND: Patients use mail delivery as a convenient alternative to acquiring medications in person. Federal laws require nonspecialty oral medications to be stored at controlled room temperature during distribution; however, no laws or regulations govern temperature requirements for medication transport among patients, which may expose medications to harmful temperature excursions. OBJECTIVE: The purpose of this study was to evaluate temperature excursions during mail transit based on the shipment method, carrier, and season. METHODS: This prospective study monitored temperature fluctuations during simulated mail transit between New Jersey, California, and Tennessee over winter (December 2019-February 2020) and summer (August-September 2020) time frames. Packages with data-logging thermometers were shipped to 3 U.S. destinations via 3 common mail carriers and 2 popular shipping methods. Three packages were mailed for each combination of season, carrier, and shipping method, representing 36 individual packages. The primary end point was percent of transit time out of range (OOR) based on the United States Pharmacopeia <659> recommended range, 68°F to 77°F. Additional end points include package transit durations and extreme temperatures. RESULTS: Evaluated packages spent an average of 68.3% of transit time OOR. In winter, 3-day and next business day packages spent similar time OOR (80.1% vs. 78%). In summer, 3-day packages spent more time OOR compared with next business day shipping (43.1% vs. 13.6%). Mean transit time was statistically significantly longer for 3-day packages (406.6 hours vs. 303.1 hours; P < 0.0001). Mean winter transit time was statistically significantly longer than summer (475.7 hours vs. 233.9 hours; P < 0.001) regardless of the shipping method. The minimum and maximum temperatures recorded were 5.1°F and 102.3°F, respectively. CONCLUSION: Package temperatures were outside of the recommended range for most of the transit time regardless of the shipping method, carrier, or season.

Age demographics of subjects enrolled in interventional phase 3 multiple myeloma clinical trials.

The mean and median ages of diagnosis of multiple myeloma range from 70 to 73 years old, with 63% of patients being over the age of 65. Phase 3 clinical trials are designed to study efficacy in the target disease population and are meant to have the most representative subject pool. The purpose of this review is to identify the age demographic of subjects participating in interventional phase 3 clinical trials that aim to treat multiple myeloma and to determine if they encompass the true age demographic of the disease. To complete this review, a search of phase 3 multiple myeloma research trials with reported results was conducted on clinicaltrials.gov, a national, publicly available resource listing clinical trials. Reported mean or median ages of subjects were identified for each trial, and adjusted averages of these values were calculated. Data from 81 clinical trials were assessed, with 42 trials reporting an average mean age of 65.78 years and 15 trials reporting an average median age of 63.29 years. Based on these results, it was determined that the clinical trials reported in this study enrolled patients that were younger than the true age demographic of the disease. There is an unmet need in research in the older population of patients with multiple myeloma, and this may hinder the generalizability and utility of clinical trial results.

Testicular torsion in brothers.

Testicular torsion is a common pediatric emergency. Predisposing factors and other risk factors for testicular torsion have not been fully elucidated. This case report highlights teenage brothers who each experienced right-sided testicular torsion at nearly the same age, just 1 year apart. Because of their parents' urgency in seeking medical attention, the affected testicles in both patients were salvaged. We also review the current literature in regards to etiology, inheritance, and patient and parental education.

Perinatal antibiotics alter preterm infant EEG and neurobehavior in the Family Nurture Intervention trial.

Early exposure to antibiotics has been shown to increase risk for poor neurobehavioral development, particularly with regard to attention deficit disorders. Clinically, electroencephalography (EEG) is increasingly used as a biomarker of these deficits. Less is known about the effects of antibiotics on neurobehavioral and neurophysiological outcomes in preterm infants, a population at particularly high risk for attention deficits and perinatal antibiotic exposure. This study examines the effects of perinatal antibiotic exposure on neonatal EEG and attention deficits as measured by the Child Behavior Checklist in 4- to 5-year-old children who were enrolled in an NICU-based randomized controlled trial comparing Family Nurture Intervention (FNI) to standard care. Antibiotic-exposed infants had increased attention problems and there was a main effect of antibiotic exposure such that exposed infants had higher EEG power. This effect was fourfold greater in infants who received standard NICU care compared to those who received the intervention, suggesting a buffering effect of the intervention. We hypothesize that the relationship between antibiotic exposure and altered neurodevelopment may be due to effects of antibiotics on the microbiome, and that FNI may buffer these adverse consequences.

Family nurture intervention in preterm infants increases early development of cortical activity and independence of regional power trajectories.

AIM: Premature delivery and maternal separation during hospitalisation increase infant neurodevelopmental risk. Previously, a randomised controlled trial of Family Nurture Intervention (FNI) in the neonatal intensive care unit demonstrated improvement across multiple mother and infant domains including increased electroencephalographic (EEG) power in the frontal polar region at term age. New aims were to quantify developmental changes in EEG power in all brain regions and frequencies and correlate developmental changes in EEG power among regions. METHODS: EEG (128 electrodes) was obtained at 34-44 weeks postmenstrual age from preterm infants born 26-34 weeks. Forty-four infants were treated with Standard Care and 53 with FNI. EEG power was computed in 10 frequency bands (1-48 Hz) in 10 brain regions and in active and quiet sleep. RESULTS: Percent change/week in EEG power was increased in FNI in 132/200 tests (p < 0.05), 117 tests passed a 5% False Discovery Rate threshold. In addition, FNI demonstrated greater regional independence in those developmental rates of change. CONCLUSION: This study strengthens the conclusion that FNI promotes cerebral cortical development of preterm infants. The findings indicate that developmental changes in EEG may provide biomarkers for risk in preterm infants as well as proximal markers of effects of FNI.

Bullying has a potential role in pediatric lower urinary tract symptoms.

PURPOSE: National statistics estimate that a quarter of American school children are regularly bullied, making this issue the main parental concern and the leading form of school violence. To our knowledge no study in the literature has examined the association of bullying with lower urinary tract symptoms. We evaluated the relationship between being bullied and lower urinary tract symptoms in the pediatric population. MATERIALS AND METHODS: We accrued 100 patients from a pediatric urology practice in prospective case-control fashion. The degree of lower urinary tract symptoms was determined by the voiding severity score obtained by a single pediatric urologist. Using the Peer Relations Questionnaire and a thermometer scale we surveyed participants for evidence of victimization from bullying and school related anxiety. We then correlated voiding symptom severity with the degree of bullying. RESULTS: After applying our study exclusion criteria we examined and analyzed data on 38 control children without lower urinary tract symptoms and on 38 children with lower urinary tract symptoms. Mean age was similar in the 2 groups. There were more females in the group with lower urinary tract symptoms (22 vs 13). Mean case voiding severity score was 3.82 (range 2 to 5). As measured by Bullied Index Score the degree of being bullied was significantly higher in the case group (4.76 vs 1.95, p <0.001), as was the anxiety level estimated by the thermometer score (3.68 vs 0.97, p <0.001). We also found that physical forms of bullying accounted for worse voiding severity scores (4.56 vs 3.67, p <0.01). CONCLUSIONS: To our knowledge our study is the first to show that 1) bullying is significantly associated with pediatric lower urinary tract symptoms and 2) physical forms of bullying accompany worsened symptoms.

Untethering an unusual cause of kidney injury in a teenager with Down syndrome.

Acute kidney injury (AKI) is characterized by the acute nature and the inability of kidneys to maintain fluid homeostasis as well as adequate electrolyte and acid-base balance, resulting in an accumulation of nitrogenous waste and elevation of serum blood urea nitrogen and creatinine values. Acute kidney injury may be a single isolated event, yet oftentimes, it results from an acute chronic kidney disease. It is critical to seek out the etiology of AKI and to promptly manage the underlying chronic kidney disease to prevent comorbidities and mortality that may ensue. We described a case of a 16-year-old adolescent girl with Down syndrome who presented with AKI and electrolyte aberrance.Abdominal and renal ultrasounds demonstrated a significantly dilated bladder as well as frank hydronephrosis and hydroureter bilaterally. Foley catheter was successful in relieving the obstruction and improving her renal function. However, a magnetic resonance imaging was pursued in light of her chronic constipation and back pain, and it revealed a structural defect (tethered cord) that underlies a chronic process that was highly likely contributory to her AKI. She was managed accordingly with a guarded result and required long-term and close monitoring.

Comparison of a Valveless Trocar System and Conventional Insufflation in Pediatric Urologic Surgery.

Background: Conventional operative insufflation uses a one-way trocar to handle instruments while maintaining pneumoperitoneum. In 2007, the AirSeal® valveless trocar insufflation system was introduced, which maintains stable pneumoperitoneum while continuously evacuating smoke. Although this device has been validated in adult patients, it has not been extensively validated in the pediatric population. Materials and Methods: A retrospective cohort study of pediatric urology patients aged 0 to 21 who underwent laparoscopic pyeloplasty between March 2016 and October 2021 was performed. Intraoperative physiologic parameters, procedure characteristics, postoperative outcomes, and demographics of each patient in whom either AirSeal insufflation system (AIS) or conventional insufflation system (CIS) was utilized were obtained from hospital records. Data were compared across the AIS and CIS cohorts. The primary outcomes were intraoperative anesthetic and physiologic parameters, including end tidal carbon dioxide, oxygen saturation, body temperature, positive inspiratory pressure, systolic blood pressure, and heart rate. Results: There were no significant differences in the anesthetic and physiologic parameters in the AIS and CIS groups. In addition, no differences in demographics, procedural characteristics, or complication rates were found between the cohorts. Conclusion: The AirSeal valveless trocar insufflation system demonstrates comparable intraoperative anesthetic and physiologic outcomes compared to conventional one-way valve insufflation in pediatric laparoscopic pyeloplasty. Certain surgeon-related qualitative metrics are underappreciated in this study, however, including improved visualization with vigorous suctioning and pressure maintenance with frequent instrument exchanges. Surgeon experience may mask the benefits of these characteristics as it pertains to quantitative surgical outcomes such as estimated blood loss, operative time, and perioperative complications.

A Framework for Engaging Healthcare Professional Trainees as Continuing Education Activity Planners and Speakers.

Health professional education and post-graduate training programs, including residencies, fellowships, and other post-graduate training experiences, may encourage or require trainee participation in continuing education (CE) activity planning and development. Providers of CE should ensure appropriate mentorship and faculty guidance during development of the activity and provide direction on the expectations of adult learning principles (e.g. identification of an educational gap; development of measurable learning objectives; inclusion of independent, balanced, and evidenced-based content; use of active learning techniques; and incorporation of learning assessment methods). Nonetheless, there is no established best practice or approach for how CE providers should ensure trainees are prepared to serve as CE activity faculty. New practitioners provided with an opportunity to participate may be unsure of where to begin and may be hesitant to engage in this new activity. In this manuscript, authors delineate key principles to incorporate when introducing trainees to CE activity development and share outcomes associated with a comparison of trainee- vs. faculty-developed and delivered CE.

Chemotherapy Refractory Spindle-Cell Rhabdomyosarcoma of the Bladder Treated With Consolidative Ovarian-Sparing Radical Surgery.

We present a case of chemotherapy refractory spindle cell rhabdomyosarcoma of the lower urinary tract in a 15-month-old female that ultimately required consolidative surgery with cystectomy, urethrectomy, ovarian-sparing hysterectomy, bilateral salpingectomy, anterior vaginal wall resection, and bilateral pelvic lymph node dissection. Genitourinary reconstruction was performed by ileal conduit creation and vaginoplasty. After completion of her maintenance postoperative chemotherapy regimen, the patient has remained disease-free for approximately 27 months.

Health Literacy Level and Comprehension of Prescription and Nonprescription Drug Information.

The aim of this study was to investigate the level of misunderstanding of medication information in Korean adults after stratifying by level of health literacy and to identify the factors influencing the misunderstanding of medication information and reading amounts of information on OTC drug labels. A cross-sectional survey was performed with 375 adult participants using the survey instrument. Multiple linear regression analyses were performed to identify factors which influence misunderstanding of medication information. Participants misunderstood 20% of words on OTC drug labels, 9% of prescription drug instructions, and 9% of pictograms. Participants on average read 59% of the overall contents of the OTC drug labels. As prescription drugs' dosing regimens became more complicated, the level of misunderstanding instructions increased. The level of misunderstanding words on OTC drug labels significantly decreased as participants had adequate health literacy (ß = −18.11, p < 0.001) and higher education levels (ß = −6.83, p < 0.001), after adjusting for the study variables. The level of misunderstanding instructions for prescription drugs increased as participants became older (ß = 8.81, p < 0.001) and had lower education levels (ß = −5.05, p < 0.001), after adjusting for the study variables. The level of misunderstanding pictograms was similar to that of misunderstanding instructions for prescription drug labels. The amount of reading information on OTC drug labels significantly increased as respondents had adequate health literacy (ß = 9.27, p < 0.001), were older (ß = 12.49, p < 0.001), or had chronic diseases (ß = 7.49, p = 0.007). Individuals' health literacy level, reading behaviors, and complexity of medication instructions are associated with misunderstanding of medication information. Appropriate word choices in drug labels and an improved format of medication instructions could increase understanding of medication information and prevent adverse drug reactions.

Age Demographics of Subjects Enrolled in Global, Interventional Phase 3 Melanoma Clinical Trials.

BACKGROUND: Melanoma is a skin cancer with a rising worldwide incidence of just over 280,000 individuals with the greatest burden of illness in European, New Zealander, and Australian populations. Patients are diagnosed with melanoma with the mean and median ages being 65 and 59 years old, respectively. Phase 3 trials not only provide a wide representation of the target population but also study the efficacy for a certain intervention. OBJECTIVE: The objective of this literature review is to analyze patient demographics of phase 3 trials for melanoma and identify if there is a true disparity between the clinical trial age demographics and the natural epidemiological age demographics. DATA SOURCES: The authors conducted a search on clinicaltrials.gov, a publicly available resource that lists clinical trials and their data. The reported mean and median ages for each trial were extracted after determining if each trial meets our inclusion criteria. Weighted mean and median ages were calculated using an online calculator. Data from 35 trials were evaluated with 30 trials reporting a weighted mean age of 55.85 years and 5 trials reporting a weighted median age of 55.14 years. CONCLUSION: Based on the results, melanoma clinical trials enroll patients who are younger than the epidemiological mean and median ages. Due to this underrepresentation of the elderly patients with melanoma, clinical trials may provide limited application for the use of their results.

Opioid abuse risk among student pharmacists.

OBJECTIVE: To benchmark opioid abuse risk among student pharmacists attending three northeast pharmacy schools utilizing the opioid risk tool (ORT). DESIGN: A cross-sectional, anonymous risk assessment questionnaire. SETTING: Three pharmacy schools in the northeast United States. PARTICIPANTS: Professional year 1 (P1) through professional year 3 (P3) student pharmacists. METHODS: ORT was collected and scored by investigators and inputted into an electronic format for analysis. Students voluntarily participated, and 812 surveys were completed during one course meeting time and day at each school. RESULTS: The majority of students were in the low-risk category (n = 581, 71.6 percent). Additionally, 137 (16.9 percent) patients were categorized as moderate risk and 94 (11.6 percent) as high risk. No statistically significant differences existed when comparing risk groups across the first through third professional year student pharmacist cohorts. There were no statistically significant differences in the proportion of risk groups among the three pharmacy cohorts between low-risk versus the high-risk groups. When comparing risk groups by gender, males were found to have a statistically significant higher proportion of being classified as moderate or high risk. CONCLUSIONS: The results of this study demonstrate that there may be some student pharmacists with an increased risk for opioid abuse potential. There is potential need for education regarding opioid risk awareness and abuse prevention, which may serve as a call to action for professional school students and practitioners to understand baseline opioid abuse risk if they require chronic pain therapy.

Survival of nonseminomatous germ cell tumors in pediatric patients and young adults - A stage group stratified analysis.

INTRODUCTION: Testicular germ cell tumors, particularly nonseminomatous germ cell tumors (NSGCT), comprise the most common solid malignancy in male children and younger adults. While these patients experience excellent survival outcomes, few studies have characterized their survival by age. Thus, we aimed to characterize the relative survival of NSGCT by age, stratifying patients by stage group. METHODS: Using the Surveillance Epidemiology and End Results (SEER) database, we divided patients with NSGCT into pediatric patients and adolescents (<19 years), young adults (19-30 years), and older adults (>30 years). Survival analysis, using Cox proportional hazards models and Kaplan Meier curves, described overall and cancer-specific survival (CSS) of each age category for Stage I-III NSGCT by stage group. RESULTS: A total of 14,786 patients met inclusion criteria and comprised the age groups <19 years (N=1,287), 19 to 30 years (N=7,729), and >30 years (N=5,770). Stage group distribution at presentation was similar between each group. Survival analysis demonstrated no differences in cancer-specific survival (CSS) among Stage I or II NSGCT. However, among Stage III tumors, multivariable models noted worse CSS in patients >30 years (HR=3.35 (95%CI: 1.45-7.73), P=0.005) and those 19-30 years (HR=2.28 (95%CI: 0.99-5.21), P=0.053) compared to pediatric and adolescent patients. CONCLUSIONS: Younger NSGCT patients experience excellent oncologic outcomes compared to their older counterparts. These survival differences by age group are largely driven by differential survival among Stage III neoplasms. Furthermore, our report lends additional evidence that age is an important prognostic factor in advanced NSGCT, including pediatric and adolescent patients.

Evaluation of consistency between physician clinical impression and 3 validated survey instruments for measuring lower urinary tract symptoms in children.

PURPOSE: Since many children with lower urinary tract symptoms are treated based on history and physical, it is important to know which symptom survey correlates best with the physician clinical impression. We evaluated 3 tools that have been demonstrated to predict severity of lower urinary tract symptoms, the Dysfunctional Voiding Symptom Score, the Akbal survey and the Nelson survey. Total scores from each survey were compared to clinical impression. MATERIALS AND METHODS: Participants consisted of 36 males and 35 females referred to our pediatric urology center for lower urinary tract symptoms. A total of 37 children 4 to 10 years old completed the Dysfunctional Voiding Symptom Score with the help of their parents, and 34 of these parents completed the Akbal survey. A total of 35 children 11 to 17 years old completed the Nelson survey. Scores from the 3 instruments were compared to the clinical impression of a pediatric urologist using rank correlation (Kendall's tau-b test). RESULTS: Mean total symptom scores were increased relative to physician rating for all 3 surveys. Symptoms reported by younger children using the Dysfunctional Voiding Symptom Score correlated better with physician rating of symptom severity (tau-b 0.43) compared to symptoms reported by parents using the Akbal survey (tau-b 0.41). Older children reporting symptoms using the Nelson survey had the strongest correlation with physician clinical impression (tau-b 0.48). CONCLUSIONS: All 3 surveys were statistically significantly correlated with the physician impression of severity for lower urinary tract symptoms, with the Nelson survey being the most accurate.

Voiding dysfunction in the female patient: is the "syndrome" paradigm valid?

Voiding dysfunction in the female patient significantly affects the patient's quality of life. The condition is poorly understood, has varied etiology and clinical presentation, and lacks standard definitions with no consensus on diagnostic criteria. It consists of a constellation of symptoms involving both phases of the micturition cycle. Appropriate diagnosis and treatment of female lower urinary tract symptoms (LUTS) is of paramount importance. However, the differentiation of female LUTS into various syndromes is currently controversial. This article comprehensively reviews the commonly encountered female non-neurogenic LUTS (overactive bladder, interstitial cystitis, and painful bladder syndrome); discusses the contemporary management of these syndromes; and emphasizes a syndromic approach to the condition.

Pharmacists' Perceptions and Drivers of Immunization Practices for COVID-19 Vaccines: Results of a Nationwide Survey Prior to COVID-19 Vaccine Emergency Use Authorization.

BACKGROUND: Pharmacists play a vital role in recommending and providing vaccines to improve public health and are on the front line of mass immunization efforts. AIM: The objective of this study is to evaluate pharmacists' perceptions on COVID-19 vaccines prior to emergency use authorization (EUA) amid a global pandemic. METHODS: A voluntary, anonymous, cross-sectional survey was conducted between September and November 2020. Survey respondents included a convenience sample of licensed pharmacists in the United States. The primary outcomes were pharmacists' willingness to receive and recommend hypothetical COVID-19 vaccines. Covariates assessed in the survey included COVID-19 exposure or personal experience, primary pharmacy practice setting, background in training, geographic region, and prioritization of clinical data. The data were analyzed using descriptive and inferential statistics. RESULTS: This study surveyed 763 pharmacists and results from 632 participants were included in final analysis. Overall, 67.1% of the pharmacists were willing to receive a COVID-19 vaccine and 63.4% of the pharmacists were willing to recommend a COVID-19 vaccine at ≤1 year from the time of vaccine approval. At >1 year after vaccine approval, 78% of the pharmacists were willing to receive a COVID-19 vaccine and 81.2% of the pharmacists were willing to recommend a COVID-19 vaccine. CONCLUSIONS: Survey findings suggest that, while a majority of pharmacists surveyed indicate acceptance of hypothetical COVID-19 vaccines, there remains to be hesitancy among pharmacists to receive or recommend vaccination.

Sentiment of Media Coverage and Reputation of the Pharmaceutical Industry.

BACKGROUND: Patients and health care professionals receive information about pharmaceutical companies through various sources, including but not limited to print media, social media, and electronic media. The objective of this research was to benchmark the sentiment of electronic newspaper media coverage between 2014 and 2016 and investigate the potential relationship to the public perception of the select pharmaceutical companies. METHODS: Reputation Institute's RepTrak System report was used for selection of 5 highly rated pharmaceutical companies (A-E). Electronic newspapers were selected based on US circulation within the selected time period. Lexalytics sentiment analysis software was used for analysis of relevant articles appearing in the selected newspapers. RESULTS: A total of 797 articles were analyzed; 63% were assessed as neutral, 24% as negative, and 14% as positive. The overall median sentiment scores (scale ranging from -2 through [Formula: see text]2) for companies A through E across all newspapers were determined to be [Formula: see text]0.026, [Formula: see text]0.03, [Formula: see text]0.028, [Formula: see text]0.034, and [Formula: see text]0.033, respectively. The most frequent topics were merger/acquisition/ re-structuring, finances/stocks/profits, and other, which included topics such as transparency of pharmaceutical industry data, lack of drug efficacy, and innovation. CONCLUSION: Overall, pharmaceutical companies were represented similarly across newspapers and most articles were assessed as neutral. However, on analysis of all nonneutral articles, all categories were assessed as negative with the exception of finances/stocks/profits.

Family nurture intervention alters relationships between preterm infant EEG delta brush characteristics and term age EEG power.

OBJECTIVE: Family Nurture Intervention (FNI) facilitates mother/infant emotional connection, improves neurodevelopmental outcomes and increases electroencephalogram (EEG) power at term age. Here we explored whether delta brushes (DB), early EEG bursts that shape brain development, are altered by FNI and mediate later effects of FNI on EEG. METHODS: We assessed DB characteristics in EEG data from a randomized controlled trial comparing infants with standard care (SC, n = 31) versus SC + FNI (n = 33) at ~35 and ~40 weeks GA. RESULTS: Compared to SC infants, FNI infant DB amplitude increased more from ~35 to ~40 weeks, and FNI infants had longer duration DBs. DB parameters (rate, amplitude, brush frequency) at ~35 weeks were correlated with power at ~40 weeks, but only in SC infants. FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term. CONCLUSIONS: DBs are related to subsequent brain activity and FNI alters DB parameters. However, FNI's effects on electrocortical activity at term age are not dependent on its earlier effects on DBs. SIGNIFICANCE: While early DBs can have important effects on later brain activity in preterm infants, facilitating emotional connection with FNI may allow brain maturation to be less dependent on early bursts.

Family nurture intervention in the NICU increases autonomic regulation in mothers and children at 4-5 years of age: Follow-up results from a randomized controlled trial.

BACKGROUND: Maturation of multiple neurobehavioral systems, including autonomic regulation, is altered by preterm birth. The purpose of this study was to determine the long-term effects of Family Nurture Intervention (FNI) in the NICU on autonomic regulation of preterm infants and their mothers. METHOD: A subset of infants and mothers (48% of infants, 51% of mothers) randomly assigned to either standard are (SC), or SC plus the FNI in the NICU in a prior RCT (ClincalTrials.gov; NCT01439269) returned for follow-up assessments when the children were 4 to 5 years corrected age (CA). ECGs were collected for 10 minutes in mothers and their children while children were in their mothers' laps. Heart rate, standard deviation for heart rate, respiratory sinus arrhythmia (RSA)-an index of parasympathetic regulation, and a measure of vagal efficiency were quantified. RESULTS: Both children and mothers in the FNI group had significantly greater levels of RSA compared to the SC group (child: mean difference = 0.60, 95% CI 0.17 to 1.03, p = 0.008; mother: mean difference = 0.64, 95% CI 0.07 to 1.21, p = 0.031). In addition, RSA increased more rapidly in FNI children between infancy and the 4 to 5-year follow-up time point (SC = +3.11±0.16 loge msec2, +3.67±0.19 loge msec2 for FNI, p<0.05). These results show that the rate of increase in RSA from infancy to childhood is more rapid in FNI subjects. CONCLUSION: Although these preliminary follow-up results are based on approximately half of subjects originally enrolled in the RCT, they suggest that FNI-NICU led to healthier autonomic regulation in both mother and child, when measured during a brief face-to-face socioemotional interaction. A Pavlovian autonomic co-conditioning mechanism may underly these findings that can be exploited therapeutically.