Association of umbilical cord blood gas values with mortality and severe neurologic injury in preterm neonates <29 weeks' gestation: a national cohort study.

BACKGROUND: Umbilical cord arterial and venous blood gas values reflect the acid-base balance status of a newborn at birth. Derangement in these values has been linked to poor neonatal outcomes in term and late preterm neonates; however, the utility of these values in preterm neonates of <29 weeks' gestation is unclear. OBJECTIVE: This study aimed to determine the associations of umbilical cord arterial and venous blood gas values with neonatal mortality and severe neurologic injury in extremely preterm neonates and to identify the cutoff values associated with 2.5-fold increases or decreases in the posttest probabilities of outcomes. STUDY DESIGN: This was a retrospective cohort study of neonates who were born at 23+0 to 28+6 weeks' gestation between January 1, 2018 and December 31, 2019, and who were admitted to neonatal units in Canada. EXPOSURE: Various cut-offs of umbilical cord blood gas values and lactate values were studied. MAIN OUTCOMES AND MEASURES: The main outcomes were mortality before discharge from the neonatal unit and severe neurologic injury defined as grade 3 or 4 periventricular or intraventricular hemorrhage or periventricular leukomalacia. The outcome rates were calculated for various cutoff values of umbilical cord blood gas parameters and were adjusted for birthweight, gestational age, sex, and multiple births. Likelihood ratios were calculated to derive posttest probabilities. RESULTS: A total of 1040 and 1217 neonates had analyzable umbilical cord arterial and venous blood gas values, respectively. In the cohort, the mean (standard deviation) gestational age was 26.5 (1.5) weeks, the mean birthweight was 936 (215) g, the prevalence of mortality was 10% (105/1040), and the prevalence of severe neurologic injury was 9% (92/1016). An umbilical cord arterial pH of ≤7.1 and base excess of ≤-12 mmol/L were associated with >2.5-fold higher posttest probability of mortality, and an umbilical cord arterial or venous lactate value of <3 was associated with a 2.5-fold lower posttest probability of mortality. An umbilical cord arterial lactate value of <3 was associated with a lower posttest probability of severe neurological injury. CONCLUSION: In preterm neonates of <29 weeks' gestation, low umbilical cord arterial pH and high umbilical cord arterial base excess values were associated with a clinically important increase in the posttest probability of mortality, whereas low umbilical cord arterial or venous lactate values were associated with a decrease in the posttest probability of mortality.

Delayed cord clamping in small for gestational age preterm infants.

BACKGROUND: Infants with restricted growth for age are frequently exposed to insufficient placental circulation and are more likely to develop postnatal complications. Delayed cord clamping at birth for these infants requires further exploration. OBJECTIVE: This study aimed to compare the short-term neonatal outcomes of delayed cord clamping with that of early cord clamping in small for gestational age preterm infants and to explore whether the effects of delayed cord clamping in small for gestational age preterm infants are different from that in non-small for gestational age preterm infants. STUDY DESIGN: We conducted a national retrospective cohort study, including infants born at <33 weeks' gestation and admitted to the Canadian Neonatal Network units between January 2015 and December 2017. Small for gestational age infants (birthweight of <10th percentile for gestational age and sex) who received delayed cord clamping ≥30 seconds were compared with those who received early cord clamping. In addition, non-small for gestational age infants who received delayed cord clamping were compared with those who received early cord clamping. The main study outcomes included composite outcome of mortality or major morbidity, neonatal morbidity rate, mortality rate, peak serum bilirubin, and number of blood transfusions. Multivariable logistic and linear regression models with a generalized estimation equation approach were used to account for the clustering of infants within centers. RESULTS: Overall, 9722 infants met the inclusion criteria. Of those infants, 1027 (10.6%) were small for gestational age. The median (interquartile range) gestational age was 31 weeks (range, 28-32 weeks). After adjusting for potential confounders, delayed cord clamping in small for gestational age infants was associated with a reduction in the composite outcome of mortality or major morbidity (adjusted odds ratio, 0.60; 95% confidence interval, 0.42-0.86) compared with early cord clamping. There was no difference between the 2 groups in peak serum bilirubin. Many associated benefits of delayed cord clamping in small for gestational age infants were similar to those in non-small for gestational age infants. CONCLUSION: Delayed cord clamping in small for gestational age preterm infants was associated with decreased odds of mortality or major morbidity. Many of the benefits of delayed cord clamping in the small for gestational age preterm infants were similar to those identified in the non-small for gestational age preterm infants.

Emergency department clinical leads' experiences of implementing primary care services where GPs work in or alongside emergency departments in the UK: a qualitative study.

BACKGROUND: To manage increasing demand for emergency and unscheduled care NHS England policy has promoted services in which patients presenting to Emergency Departments (EDs) with non-urgent problems are directed to general practitioners (GPs) and other primary care clinicians working within or alongside emergency departments. However, the ways that hospitals have implemented primary care services in EDs are varied. The aim of this study was to describe ED clinical leads' experiences of implementing and delivering 'primary care services' and 'emergency medicine services' where GPs were integrated into the ED team. METHODS: We conducted interviews with ED clinical leads in England (n = 19) and Wales (n = 2). We used framework analysis to analyse interview transcripts and explore differences across 'primary care services', 'emergency medicine services' and emergency departments without primary care services. RESULTS: In EDs with separate primary care services, success was reported when having a distinct workforce of primary care clinicians, who improved waiting times and flow by seeing primary care-type patients in a timely way, using fewer investigations, and enabling ED doctors to focus on more acutely unwell patients. Some challenges were: trying to align their service with the policy guidance, inconsistent demand for primary care, accessible community primary care services, difficulties in recruiting GPs, lack of funding, difficulties in agreeing governance protocols and establishing effective streaming pathways. Where GPs were integrated into an ED workforce success was reported as managing the demand for both emergency and primary care and reducing admissions. CONCLUSIONS: Introducing a policy advocating a preferred model of service to address primary care demand was not useful for all emergency departments. To support successful and sustainable primary care services in or alongside EDs, policy makers and commissioners should consider varied ways that GPs can be employed to manage variation in local demand and also local contextual factors such as the ability to recruit and retain GPs, sustainable funding, clear governance frameworks, training, support and guidance for all staff. Whether or not streaming to a separate primary care service is useful also depended on the level of primary care demand.

"What would you recommend doctor?"-Discourse analysis of a moment of dissonance when sharing decisions in clinical consultations.

BACKGROUND: Proven benefits of Shared Decision Making (SDM) include improved patient knowledge, involvement and confidence in making decisions. Although widely advocated in policy, SDM is still not widely implemented in practice. A common patient-reported barrier is feeling that "doctor knows best"; thus, patients often defer decisions to the clinician. OBJECTIVE: To examine the nature of the discourse when patients ask clinicians for a treatment recommendation during consultations when treatment decisions are being shared and to examine clinicians' strategies used in response. DESIGN, SETTING AND PARTICIPANTS: Theme-orientated discourse analysis was performed on eight audio-recordings of breast cancer diagnostic consultations in which patients or their partners attempted to defer treatment decisions to the clinician. Clinicians were trained in SDM. RESULTS: Tension was evident in a number of consultations when treatment recommendations were requested. Clinicians responded to recommendation requests by explaining why the decision was being shared (personal nature of the decision, individual preferences and equivalent survival outcomes of treatment options). There was only one instance where a clinician gave a treatment recommendation. DISCUSSION AND CONCLUSIONS: Strategies for clinicians to facilitate SDM when patients seem to defer decisional responsibility include being clear about why the decision is being shared, acknowledging that this is difficult and making patients feel supported. When patients seek guidance, clinicians can provide a recommendation if grounded in an understanding of the patient's values.

Outcome of patients with gastroschisis managed with and without multidisciplinary teams in Canada.

OBJECTIVE: To describe the outcomes of gastroschisis (GS) patients managed with and without a multidisciplinary team during the postoperative period in Canada. METHOD: The Canadian Pediatric Surgery Network (CAPSNet) collects patient data from all Canadian tertiary perinatal centres. The outcomes of 396 GS patients born between 2005 and 2009 who were managed with and without a multidisciplinary team were analyzed. RESULTS: Significantly more parenteral nutrition (PN) days (P=0.003) and longer lengths of stay (P=0.018) were observed among patients in centres with multidisciplinary teams. Higher mortality rate and earlier death were observed in centres without multidisciplinary teams, especially for high-risk patients, although this was not statistically significant. With regard to low-risk patients, those in centres with multidisciplinary teams had significantly more PN days (P=0.019). CONCLUSIONS: GS patients managed by multidisciplinary teams had significantly more PN days and longer lengths of stay compared with patients who were not managed by multidisciplinary teams. This difference may be due to improved survival of high-risk patients in centres with multidisciplinary teams, and a uniform feeding approach for all patients.

OBJECTIF: Décrire l'évolution des patients ayant un gastroschisis (GS) traités ou non par une équipe multidisciplinaire pendant la période postopératoire au Canada. MÉTHODOLOGIE: Le Réseau canadien de chirurgie pédiatrique (CAPSNet) collige les données sur les patients de tous les centres périnatals de soins tertiaires au Canada. L'évolution de 396 patients ayant un GS nés entre 2005 et 2009 et qui ont été traités ou non par une équipe multidisciplinaire a été analysée. RÉSULTATS: Les patients hospitalisés dans des centres dotés d'équipes multidisciplinaires passaient considérablement plus de jours sur alimentation parentérale (AP) (P=0,003) et étaient hospitalisés plus longtemps (P=0,018). Bien que ce résultat ne soit pas significatif, le taux de mortalité était plus élevé et les décès, plus rapides dans les centres ne disposant pas d'une équipe multidisciplinaire, surtout chez les patients à haut risque. Pour ce qui est des patients à faible risque, ceux qui étaient traités dans des centres disposant d'une équipe multidisciplinaire passaient considérablement plus de jours sur AP (P=0,019). CONCLUSIONS: Les patients ayant un GS traités par une équipe multidisciplinaire passaient considérablement plus de jours sur AP et étaient hospitalisés plus longtemps que ceux qui n'étaient pas traités par une telle équipe. Cette différence peut être attribuable au meilleur taux de survie des patients à haut risque dans les centres disposant d'équipes multidisciplinaires et à une approche uniforme en matière d'alimentation pour tous les patients.

CPAP Versus NIPPV Postextubation in Preterm Neonates: A Comparative-Effectiveness Study.

BACKGROUND AND OBJECTIVES: Nasal intermittent positive pressure ventilation (NIPPV) has been shown to be superior to nasal continuous positive airway pressure (CPAP) postextubation in preterm neonates. However, studies have not permitted high CPAP pressures or rescue with other modes. We hypothesized that if CPAP pressures >8 cmH2O and rescue with other modes were permitted, CPAP would be noninferior to NIPPV. METHODS: We conducted a pragmatic, comparative-effectiveness, noninferiority study utilizing network-based real-world data from 22 Canadian NICUs. Centers self-selected CPAP or NIPPV as their standard postextubation mode for preterm neonates <29 weeks' gestation. The primary outcome was failure of the initial mode ≤72 hours. Secondary outcomes included failure ≤7 days, and reintubation ≤72 hours and ≤7 days. Groups were compared using a noninferiority adjusted risk-difference (aRD) margin of 0.05, and margin of no difference. RESULTS: A total of 843 infants extubated to CPAP and 974 extubated to NIPPV were included. CPAP was not noninferior (and inferior) to NIPPV for failure of the initial mode ≤72 hours (33.0% vs 26.3%; aRD 0.07 [0.03 to 0.12], Pnoninferiority(NI) = .86), and ≤7 days (40.7% vs 35.8%; aRD 0.09 [0.05 to 0.13], PNI = 0.97). However, CPAP was noninferior (and equivalent) to NIPPV for reintubation ≤72 hours (13.2% vs 16.1%; aRD 0.01 [-0.05 to 0.02], PNI < .01), and noninferior (and superior) for reintubation ≤7 days (16.4% vs 22.8%; aRD -0.04 [-0.07 to -0.001], PNI < .01). CONCLUSIONS: CPAP was not noninferior to NIPPV for failure ≤72 hours postextubation; however, it was noninferior to NIPPV for reintubation ≤72 hours and ≤7 days. This suggests CPAP may be a reasonable initial postextubation mode if alternate rescue strategies are available.

Cost analysis for mirabegron use in the treatment of children with neurogenic bladder.

INTRODUCTION: Mirabegron is a beta-3 adrenergic receptor agonist that received FDA approval in 2021 to treat neurogenic detrusor overactivity (NDO) in children ages three years and older. Despite its safety and efficacy, access to mirabegron frequently remains restricted by payor coverage policies. OBJECTIVE: This cost minimization study sought to determine the cost implications from a payor perspective of mirabegron use at different points in the treatment pathway for pediatric NDO. STUDY DESIGN: A Markov decision analytic model was constructed to assess the costs for eight treatment strategies over a 10-year period, using six-month cycles (Table). Five strategies involve mirabegron use as first-, second-, third-, or fourth-line therapy. Two strategies, including the "base case," entail use of anticholinergic medications followed by onabotulinum toxin type A (Botox) injection and augmentation cystoplasty. A strategy involving first-line Botox was also modeled. The effectiveness, adverse event rates, attrition rates, and costs associated with each treatment option were obtained from the clinical literature and adjusted to a six-month cycle. Costs were adjusted to 2021-dollar value. A discount rate of 3% was used. To quantify uncertainty, costs and treatment transition probabilities were modeled as gamma and PERT distributions, respectively. One-way sensitivity analyses were performed. Probabilistic sensitivity analysis (PSA) was conducted using a Monte Carlo simulation with 100,000 iterations. Analyses were performed using Treeage Pro (Healthcare Version). RESULTS: The least costly strategy involved first-line mirabegron (expected cost $37,954). All strategies involving mirabegron were less costly than the base case ($56,417). On PSA, first-line mirabegron was the least costly strategy in 88.9% of cases (mean $37,604, 95% CI: $37,579-37,628); in 100% of cases, the least costly strategy involved mirabegron use. Cost savings associated with mirabegron use were attributable to decreased use of augmentation cystoplasty and Botox injections. DISCUSSION: This is the first study to compare costs across multiple strategies involving mirabegron to treat pediatric NDO. Mirabegron use likely yields cost savings for the payor: the least costly strategy involved first-line mirabegron, and all pathways incorporating mirabegron were less costly than those without mirabegron use. These findings provide an updated cost analysis for the treatment of NDO by investigating mirabegron use alongside more established treatment options. CONCLUSION: Use of mirabegron for the treatment of pediatric NDO is likely associated with cost savings as compared to treatment pathways without mirabegron. Expansion of payor coverage for mirabegron, as well as clinical studies to study first-line mirabegron use, should be considered.

Causes of death among people with myelomeningocele: A multi-institutional 47-year retrospective study.

PURPOSE: This study aimed to analyze organ system-based causes and non-organ system-based mechanisms of death (COD, MOD) in people with myelomeningocele (MMC), comparing urological to other COD. METHODS: A retrospective review was performed of 16 institutions in Canada/United States of non-random convenience sample of people with MMC (born > = 1972) using non-parametric statistics. RESULTS: Of 293 deaths (89% shunted hydrocephalus), 12% occurred in infancy, 35% in childhood, and 53% in adulthood (documented COD: 74%). For 261 shunted individuals, leading COD were neurological (21%) and pulmonary (17%), and leading MOD were infections (34%, including shunt infections: 4%) and non-infectious shunt malfunctions (14%). For 32 unshunted individuals, leading COD were pulmonary (34%) and cardiovascular (13%), and leading MOD were infections (38%) and non-infectious pulmonary (16%). COD and MOD varied by shunt status and age (p < = 0.04), not ambulation or birthyear (p > = 0.16). Urology-related deaths (urosepsis, renal failure, hematuria, bladder perforation/cancer: 10%) were more likely in females (p = 0.01), independent of age, shunt, or ambulatory status (p > = 0.40). COD/MOD were independent of bladder augmentation (p = >0.11). Unexplained deaths while asleep (4%) were independent of age, shunt status, and epilepsy (p >= 0.47). CONCLUSION: COD varied by shunt status. Leading MOD were infectious. Urology-related deaths (10%) were independent of shunt status; 26% of COD were unknown. Life-long multidisciplinary care and accurate mortality documentation are needed.

Maternal age and long-term neurodevelopmental outcomes of preterm infants < 29 weeks gestational age.

OBJECTIVE: The objective of this study is to assess the impact of maternal age on neurodevelopmental (ND) outcomes of infants < 29 weeks gestational age (GA) at 18-24 months. STUDY DESIGN: A retrospective cohort study of preterm infants < 29 weeks GA admitted to Canadian tertiary NICUs was performed. The primary outcome was a composite of death or ND impairment (NDI)/significant NDI (sNDI) at 18-24 months. Association between maternal age and outcome was assessed across maternal age groups (15-19, 20-34, 35-39 and ≥40 years) using logistic regression after adjusting for confounders. RESULTS: Of 3691 eligible infants, 2652 with complete data were included in the analysis. Significant differences in maternal characteristics existed across age groups. The only difference in neonatal characteristics was the incidence of bronchopulmonary dysplasia (p < 0.01). There was no association between maternal age and death or NDI/sNDI after controlling for confounders. CONCLUSION: Maternal age is not associated with differences in NDI/sNDI rates among Canadian preterm infants < 29 weeks GA.

A classification of primary care streaming pathways in UK emergency departments: Findings from a multi-methods study comprising cross-sectional survey; site visits with observations, semi-structured and informal interviews.

BACKGROUND: Variation in initial assessment methods at emergency departments in with primary care service models and a conflated terminology causes difficulties in assessing relative performance, improving quality or gathering evidence about safety and clinical effectiveness. We aim to describe and classify streaming pathways in emergency departments in different models of emergency department primary care services in England and Wales. METHODS: We used a multi-stage method, including an online survey completed by 77 emergency departments across England & Wales, interviews with 21 clinical leads, and in-depth case studies of 13 emergency departments. All qualitative data were triangulated and analysed using a framework approach. RESULTS: Common emergency department pathways to primary care services were: front door streaming; streaming inside the emergency department; or primary care staff selecting patients. Pathways were also in place to redirect patients with non-urgent primary care problems to community primary care services. Streaming and redirection pathways were often adapted, with variation in protocols based on local circumstances. CONCLUSION: Clinical leads should consider which pathway(s) best suit their local context. Consistency of terminology used to describe pathways between emergency departments and primary care services is necessary for performance measurement, quality improvement and rigorous future multi-site evaluative and descriptive research.

Care coordination guidelines for the care of people with spina bifida.

Care coordination is the deliberate organization of patient care activities between two or more participants (including the patient) involved in a person's care to facilitate the appropriate delivery of health care services. Organizing care involves the marshalling of personnel and other resources needed to carry out all required patient care activities. It is often managed by the exchange of information among participants responsible for different aspects of care [1]. With an estimated 85% of individuals with Spina Bifida (SB) surviving to adulthood, SB specific care coordination guidelines are warranted. Care coordination (also described as case management services) is a process that links them to services and resources in a coordinated effort to maximize their potential by providing optimal health care. However, care can be complicated due to the medical complexities of the condition and the need for multidisciplinary care, as well as economic and sociocultural barriers. It is often a shared responsibility by the multidisciplinary Spina Bifida team [2]. For this reason, the Spina Bifida Care Coordinator has the primary responsibility for overseeing the overall treatment plan for the individual with Spina Bifida[3]. Care coordination includes communication with the primary care provider in a patient's medical home. This article discusses the Spina Bifida Care Coordination Guideline from the 2018 Spina Bifida Association's Fourth Edition of the Guidelines for the Care of People with Spina Bifida and explores care coordination goals for different age groups as well as further research topics in SB care coordination.

Preventing brain injury in newborns with congenital heart disease: brain imaging and innovative trial designs.

BACKGROUND AND PURPOSE: Newborns with congenital heart disease are at high risk for brain injury and adverse neurodevelopmental outcomes. MRI enables the objective determination of the severity of brain injury in critically ill newborns with congenital heart disease. We will rationalize the use of MRI as a surrogate for neurodevelopmental outcome and describe novel randomization techniques that can be used in trials in this population. METHODS: This article describes the evidence for the use of MRI and the link with neurodevelopmental outcome established in newborns. We also discuss the use of adaptive randomization techniques for future clinical trials in newborns with congenital heart disease. These strategies will be highlighted using an example. RESULTS: Brain injuries occur with high frequency in newborns with congenital heart disease. It is not until school age that the full extent of neurological sequelae becomes apparent and the rapid pace of innovation in neonatal cardiac surgery prevents timely evaluation of changes in care. MRI provides a timely, safe, and reliable outcome measure and has been extensively studied in newborns with other conditions in which the link between brain injury and neurodevelopmental outcome has been established. Clinical trials using MRI as an outcome measure as well as adaptive randomization can improve the efficiency of such trials. CONCLUSIONS: Clinical trials of brain protection are urgently needed in newborns with congenital heart disease given the unacceptable frequency of brain injury in this population; MRI provides an early surrogate marker of long-term neurodevelopmental outcome and adaptive randomization can be used to improve the efficiency of these clinical trials.

Duration of Initial Empirical Antibiotic Therapy and Outcomes in Very Low Birth Weight Infants.

: media-1vid110.1542/5984244681001PEDS-VA_2018-2286Video Abstract BACKGROUND: Overuse of antibiotics can facilitate antibiotic resistance and is associated with adverse neonatal outcomes. We studied the association between duration of antibiotic therapy and short-term outcomes of very low birth weight (VLBW) (<1500 g) infants without culture-proven sepsis. METHODS: We included VLBW infants admitted to NICUs in the Canadian Neonatal Network between 2010-2016 who were exposed to antibiotics but did not have culture-proven sepsis in the first week. Antibiotic exposure was calculated as the number of days an infant received antibiotics in the first week of life. Composite primary outcome was defined as mortality or any major morbidity (severe neurologic injury, retinopathy of prematurity, necrotizing enterocolitis, chronic lung disease, or hospital-acquired infection). RESULTS: Of the 14 207 included infants, 21% (n = 2950), 38% (n = 5401), and 41% (n = 5856) received 0, 1 to 3, and 4 to 7 days of antibiotics, respectively. Antibiotic exposure for 4 to 7 days was associated with higher odds of the composite outcome (adjusted odds ratio 1.24; 95% confidence interval [CI] 1.09-1.41). Each additional day of antibiotic use was associated with 4.7% (95% CI 2.6%-6.8%) increased odds of composite outcome and 7.3% (95% CI 3.3%-11.4%) increased odds in VLBW infants at low risk of early-onset sepsis (born via cesarean delivery, without labor and without chorioamnionitis). CONCLUSIONS: Prolonged empirical antibiotic exposure within the first week after birth in VLBW infants is associated with increased odds of the composite outcome. This practice is a potential target for antimicrobial stewardship.

How effective is tetracaine 4% gel, before a venipuncture, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial.

BACKGROUND: Procedural pain relief is sub-optimal in neonates. Topical tetracaine provides pain relief in children. Evidence of its efficacy and safety in neonates is limited. The objective of this study was to assess the efficacy and safety of topical tetracaine on the pain response of neonates during a venipuncture. METHODS: Medically stable infants greater than or equal to 24 weeks gestation, requiring a venipuncture, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. Participants received oral sucrose if they met local eligibility criteria. The venipuncture was performed according to a standard protocol. A medium effect size in the pain score (corresponding to about 2 point difference in the PIPP score) was considered clinically significant, leading to a sample size of 142 infants, with 80% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test. RESULTS: One hundred and forty two infants were included, 33 +/- 4 weeks gestation, 2100 +/- 900 grams and 6 +/- 3 days of age. There was almost no difference in PIPP scores at 1 minute between groups (mean difference -0.09; 95% confidence interval [CI]: -1.68 to 1.50; P = . 91). Similarly, there were no differences in PIPP scores during the 2nd, 3rd and 4th minute. Duration of cry did not differ between the groups (median difference, 0; 95% CI, -3 to 0; P = . 84). The majority of infants in both groups received sucrose 24%. Sucrose had a significant effect on the PIPP score, as assessed by an ANOVA model (p = 0.0026). Local skin erythema was observed transiently in 11 infants (7 in the tetracaine and 4 in the placebo group). No serious side effect was observed. CONCLUSION: Tetracaine did not significantly decrease procedural pain in infants undergoing a venipuncture, when used in combination with routine sucrose administration.

How effective is tetracaine 4% gel, before a peripherally inserted central catheter, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial [ISRCTN75884221].

BACKGROUND: Procedural pain relief is sub-optimal in infants, especially small and vulnerable ones. Tetracaine gel 4% (Ametop, Smith-Nephew) provides pain relief in children and larger infants, but its efficacy in smaller infants and for peripherally inserted central catheters (PICC) remains uncertain. The objective of this trial was to assess the safety and efficacy of tetracaine gel on the pain response of very low birth weight (VLBW) infants during insertion of a PICC. METHODS: Medically stable infants greater than or equal to 24 weeks gestation, requiring a non-urgent PICC, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. The PICC was inserted according to a standard protocol. Pain was assessed using the Premature Infant Pain Profile (PIPP). A 3-point change in the pain score was considered clinically significant, leading to a sample size of 54 infants, with 90% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test. RESULTS: Fifty-four infants were included, 27 +/- 2 weeks gestation, 916 +/- 292 grams and 6.5 +/- 3.2 days of age. Baseline characteristics were similar between groups. The mean PIPP score in the first minute was 10.88 in the treatment group as compared to 11.74 in the placebo group (difference 0.86, 95% CI -1.86, 3.58). Median duration of crying in non-intubated infants was 181 seconds in the tetracaine group compared to 68 seconds in the placebo group (difference -78, 95% CI -539, 117). Local skin erythema was observed transiently in 4 infants (3 in the treatment and 1 in the placebo group). No serious harms were observed. CONCLUSION: Tetracaine 4% when applied for 30 minutes was not beneficial in decreasing procedural pain associated with a PICC in very small infants.

Validation of a bowel dysfunction instrument for adolescents with spina bifida.

INTRODUCTION: Existing survey instruments for bowel dysfunction in the pediatric population are either parent-reported or focus on non-neurogenic bowel dysfunction. OBJECTIVE: The purpose of this study was to develop and validate an adolescent-reported survey to assess the severity of bowel dysfunction in spina bifida patients and examine its impact on quality of life (QOL). STUDY DESIGN: We performed a cross-sectional study of patients in our Myelodysplasia Program, aged 11-17 years, with a history of constipation and/or fecal incontinence (FI) from November 2010 to June 2013. Control patients, aged 11-17 years, were recruited from the stone clinic. Exclusion criteria were lack of English fluency, insufficient reading skills, or an incontinent fecal diversion. A 29-item version of the Adolescent Fecal Incontinence and Constipation Symptom Index (A-FICSI) was developed with five domains (Figure). Test re-test reliability and correlation with the total global health-related QOL score from the Parkin survey were measured using the Pearson correlation coefficient. A factor analysis model with four-fold correlations was tested. RESULTS: Of the 65 study-eligible individuals approached, 25 (11 boys) completed the A-FICSI (median age 12.6 years, IQR 11.8-14.7 years) and 17 completed another survey on urinary incontinence (64.6% response rate). Twenty-one control patients with nephrolithiasis completed the A-FICSI. Nine of the 25 completed a second administration of the survey. The mean correlation between repeated administrations of the survey was r = 0.43. There was a significant negative correlation between severity of constipation (r = -0.299, p < 0.05) and severity of FI (r = -0.316, p < 0.05) with the total Parkin QOL score. The Comparative Fit Index (CFI) was 0.864. Most items loaded significantly on their respective factors. Between-factor correlations were all significant (>0.30) in the predicted direction. Unstandardized residuals were 8.7% (95% CI 6.4-10.9%). Item reduction was performed on the 29-item instrument based on results of the factor analysis. The finalized instrument contained 21 items. DISCUSSION: This is the first adolescent-reported bowel dysfunction instrument to undergo formal psychometric assessment in the spina bifida population. The instrument demonstrated adequate reliability and the five-factor structure fit the data well. This study highlights the negative impact of bowel dysfunction on the QOL of spina bifida patients. It is limited by the moderate sample size that is a common issue in relatively rare diseases. CONCLUSION: The A-FICSI possesses desirable psychometric properties for the measurement of bowel dysfunction in the spina bifida population.

Urinary incontinence in spina bifida: Initial instrument validation.

The purpose of this study was to perform a psychometric assessment of the Incontinence Symptom Index-Pediatric (ISI-P) in a cohort of adolescents with spina bifida (SB) and neuropathic urinary incontinence (UI) to test its validity and reliability. The ISI-P, an 11-item instrument with domains for symptom severity and impairment, was self-administered by subjects 11-17 years old with SB and UI. Controls were 11-17 years old, with nephrolithiasis and no history of UI. Formal psychometric assessment included an evaluation of internal consistency, test re-test reliability and factor analysis. Of 78 study-eligible subjects we attempted to contact, 33 (66.7% female) with a median age of 13.1 years completed the ISI-P (42.3% response rate). 21 control patients also completed the ISI-P. Cronbach's alpha was 0.936 and 0.792 for the severity and bother factors respectively. The delta Chi-square test for the two-factor (vs. one-factor) model was significantly [χ(2)(89) = 107.823, p < 0.05] in favor of the former model with descriptive fit indices being excellent (e.g., comparative fit index = 0.969). Furthermore, category information analysis showed that all categories were associated with different threshold values, namely that each category contributed unique information for the measurement of the latent trait. In conclusion, the ISI-P has desirable psychometric properties for the measurement of UI symptom severity and impairment in adolescents with SB.

Uncommon presentation of a common condition: an easily missed cause of hip pain.

Conventionally, patients presenting with hip pain and restricted mobility to accident and emergency (A&E) department are thought to have musculoskeletal pain. Occasionally, patients with significant abdominal pathology can present with hip pain. Such atypical presentation causes the delayed diagnosis leading to significant morbidity and possible mortality. We report a 63-year-old man who had been treated in A&E on numerous occasions with left hip pain for over 6 weeks. On this occasion, he had been brought in septic shock. On examination, he had subcutaneous emphysema of left lower limb. A CT scan showed a large psoas abscess resulting from retroperitoneal perforation of sigmoid diverticulitis tracking into his left lower limb. He underwent a Hartmann's procedure and drainage of his intra-abdominal sepsis. The thigh was not drained with separate incisions at the index operation. Residual thigh abscess was managed by image-guided drainage.