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Background and Aim: We compared the efficacy and safety of intramuscular with buccal midazolam as first-line treatment for active seizures in children brought to the emergency department.

Methods: In a double-blind, double-dummy randomized trial, patients with an active seizure lasting more than five minutes received blinded treatments on arrival. We employed deferred consent. The proportion of patients with cessation of seizure within five minutes of drug administration was the primary efficacy outcome; proportions needing additional medication to control seizure, duration of seizure activity, and side effects were secondary outcomes.

Results: We enrolled 150 children presenting with active seizure, age range 4.5 to 167.5 months. Cessation of seizure occurred in 61% of the intramuscular and 46% of the buccal treatment groups, (P = 0.07, difference 15.5%, 95% confidence interval for the difference -1.0 to 32.0%). Proportions requiring additional anti-seizure treatment were 39% in the intramuscular and 51% in the buccal groups. Mean duration of seizure activity after administration of study medication was 15.9 minutes (S.D. 28.7) in the intramuscular and 17.8 minutes (S.D. 27.5) in the buccal group. One patient in the intramuscular group developed respiratory depression and hypotension; there were no side effects attributed to investigational treatment in the buccal group.

Conclusions: Efficacy and safety of intramuscular midazolam as first-line treatment for pediatric seizures compare favorably to that of buccal midazolam.

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The protocol biopsies could identify histological signs of subclinical allograft rejection. It has been known that antibody-mediated rejection (ABMR) represents one of the major risk factors for reduced transplanted kidney survival. Viral infections can lead to transplant dysfunction and through the cytopathic effect and immune response they can lead to acute/chronic allograft rejection. In order to evaluate if local virus-mediated inflammation could be linked to the development of anti-donor antibody and ABMR, we retrospectively reviewed histological, donor-specific antibodies (DSA), viremia and intrarenal virus data of transplanted patients at our pediatric center from 2011 to 2016.

Histological data were obtained from protocol biopsies performed at 6, 12, 24 months after transplantation in association with DSA+ (MFI>3000). The detection of virus DNA was done by Real-time PCR for CMV, EBV, BKV, PVB19 in blood, and bioptic tissue samples at time zero of transplant (T0) and in protocol biopsies.

The analysis included 106 patients: 266 protocol biopsies, 52 diagnosed as acute/chronic rejection (69.2% cellular vs 30.8% humoral). The study did not highlight the correlation between systemic viral infection and humoral or cellular rejection. Conversely, our data emphasized that the presence of PVB19 is associated with humoral rejection compared to the cellular one (50%vs13%, p=0.04) and we could observe that only PVB19 has a prevalence in T0 biopsies (25.5%). In situ Hybridization confirmed the PVB19 endothelium localization.

This retrospective study highlights a possible association between the presence of PVB19 intragraft and ABMR. The creation of a new multicentre study will allow increasing statistical power.

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Background/ Aims

The prevalence of pediatric type 2 diabetes (T2D) has soared and its age of diagnosis has decreased. Pubertal insulin resistance has been implicated in the pathogenesis and there are sex-related differences, with higher prevalence in females. We aimed to compare the characteristics of female vs. male youth with T2D.

Methods

We studied 722 youth (62.6% female; 8.9% non-Hispanic White, 57.7% Hispanic, 30.3% Black, 3.1% other) newly diagnosed with T2D (mean age 13.7± 2.4 years) in a large academic hospital in Houston, Texas (USA). We compared demographic, clinical and laboratory characteristics within the first year of diagnosis. With Bonferroni correction for the number of independent comparisons, p-values<0.0045 were considered significant.

Results

At diagnosis of T2D, females compared with males were younger (13.4 vs 14.1 years); more likely to have reached Tanner stage 5 (47.2% vs 18.0%); had lower hemoglobin A1c (9.3 vs 10.0 %) and lower DKA frequency (5.2% vs 12.4%) (all p<0.001). Race/ethnicity, T2D family history, age/sex-adjusted BMI Z-score and C-peptide were not different. Within 1 year of diagnosis, females had higher HDL (39.1 v 35.7, p<0.0001) and tended to have lower triglycerides (p=0.02), while blood pressure percentile, non-HDL cholesterol, LDL, NAFLD and microalbuminuria were not statistically different. In multivariable analysis adjusting for BMI Z-score, younger age and being at Tanner 5 were independently associated with being female (both p<0.0001), while race was not.

Conclusions

Girls are diagnosed with T2D younger than boys, possibly due to increase insulin resistance from earlier pubertal development, but present with milder characteristics.

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Background: Our double-blind placebo-controlled randomised trial investigating hydrocortisone versus placebo in mechanically ventilated preterm infants in the second week of life found no difference for the composite outcome death or bronchopulmonary dysplasia at 36 weeks’ postmenstrual age. In this study, we assessed the outcome at two years corrected age (CA).

Methods: Preterm infants with a gestational age <30 weeks and/or birth weight <1250 grams, who were ventilator-dependent between 7-14 days of life were randomly assigned to a 22-day course of systemic hydrocortisone (cumulative dose 72.5 mg/kg; n=182) or placebo (n=190).

Results: Among 371 patients (mean gestational age 26 weeks) who completed the trial, 276 survived till two years’ CA; consent was withdrawn for one hydrocortisone treated infant. Death or neurodevelopmental impairment (NDI) occurred in 97 of 171 hydrocortisone treated infants (56.7%), and in 116 of 185 infants (62.7%) assigned to placebo (adjusted risk difference, -5.2% [95% CI -15.1 to 4.6]; adjusted odds ratio, 0.79 [95% CI 0.51 to 1.22], p=0.28). Pre-specified exploratory subgroup analysis of infants below 27 weeks gestation showed a significant reduction in the composite outcome death or NDI in the hydrocortisone group compared to the placebo group (54.6% vs. 66.2%; risk difference -11.6% [95% CI -22.4% to -0.5%], p=0.02 for interaction).

Conclusion: While the administration of hydrocortisone between 7 and 14 days after birth did not reduce the risk of death or NDI in mechanically ventilated very preterm infants, future studies should confirm the increased intact survival in infants born before 27 weeks gestation.

Table 1. Outcomes

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Background and aims: Contemporary NICU environments have constant dim lighting and noise. We hypothesised that cycled light and sound in the NICU would accelerate the development of endogenous hormonal circadian rhythms in very preterm (<32w GA) infants. We assessed circadian rhythmicity of salivary cortisol and melatonin samples obtained in hospitalised very preterm infants randomised to routine care or to a cycled light and noise environment.

Methods: sub-study of a multicentre, prospective, randomised, open, blinded end-point controlled trial (CIRCA DIEM ACTRN12618000371291). Enrolled infants were eligible for the sub-study if they were very preterm (28⁰-31⁶w GA) and parental consent for biological sample collection was obtained. Infants were randomised to standard care (control) or cycled light and noise (treatment: nocturnal eye masks and earplugs) from birth until hospital discharge. Nocturnal and daytime salivary swabs were collected (Salimetrics®) and cortisol and melatonin measured by enzyme immunoassay. Circadian hormonal rhythmicity was determined from daily trough-to-peak ratios. Timing of circadian rhythm emergence was determined using a generalised linear mixed model.

Results: Forty-two infants were recruited. Infants in the treatment group had significantly increased daily circadian variation of cortisol (p < 0.05) and melatonin (p < 0.05) from 7 d after birth until hospital discharge. The relative strength of daily rhythms increased (ratio decreased) in the treatment group throughout hospitalisation, compared with the control group.

Conclusion: Very preterm infants cared for using cycled light and noise have an earlier emergence of circadian rhythms in cortisol and melatonin compared with infants cared for in constant environmental conditions.

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Background and aims
The survival rate of children admitted to the paediatric intensive care unit (PICU) has increased dramatically. Both the critical illness and the accompanying PICU treatments, may impact these children’s future cognitive development. Yet, thus far little is known about their long-term neurocognitive outcomes. This meta-analysis aimed to examine the impact of PICU-admission on cognitive abilities as assessed by measures of intelligence and to examine the risk factors.

Methods
PubMed, EMBASE, CINAHL and PsycINFO were searched. Peer-reviewed studies, reporting intelligence scores (IQ) of children with a history of PICU-hospitalization from 1970 onwards were included. In case of no control group, we used normative data gathered in a representative sample of children. Standardized mean differences in IQ per study were pooled using random-effects meta-analysis. We examined the risk factors across studies using random-effects meta-regression analysis. Covariates included demographic and PICU-related factors.

Results
The 114 included studies, published between 1973 and 2019, comprised 8148 children with a history of PICU-admission. These children had a 0.43-SD lower IQ (equivalent to 6.5 IQ-points, a clinically relevant difference) compared with controls (95% CI -0.51 to -0.35, p<.001). Meta-regression analysis showed that calendar year of PICU-admission explained 22% of the variance in IQ across studies, with each year increase across studies being associated with a 0.02-SD decrease in IQ (0.3 IQ-points, 95% CI -0.026 to -0.01, p<.001).

Conclusions
Children with a history of PICU-admission are at risk of a decreased global neurocognitive functioning. Year of PICU admission is a risk factor for lower IQ.

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OBJECTIVE:Cardiac arrest is a dreadful event that can occur in pediatric intensive care units (PICU).Vasopressin, a potent vasoconstrictor, is well studied in adult cardiac arrests. Epinephrine plus Vasopressin may be an alternative option.METHOD:Children aged one month to 13 years who required cardiopulmonary resuscitation during PICU stay were randomized to receive Vasopressin 0.1 mL per kg (=0.8 IU per kg) or Placebo (0.1 mL per kg normal saline) in addition to Epinephrine (1:10000) 0.1 mL per kg. The drugs were given as bolus doses every three minutes until the return of spontaneous circulation (ROSC) was achieved or a maximum of five doses, whichever was earlier. The primary outcome was the proportion of patients who achieved ROSC. The secondary outcomes were survival rate and functional status (at 24-hour, PICU, hospital, and 90-day post-discharge), need for organ supports, length of stay (PICU and hospital)and adverse effect(s) of the study drugs. RESULTS: Ninety patients (Epinephrine plus Vasopressin group n=45 and Epinephrine plus Placebo group n=45) were analyzed on the intention to treat basis. There was no difference in the primary outcome between Epinephrine plus Vasopressin (55.5%), and Epinephrine plus Placebo groups (53.3%) (Relative risk 1.04, 95% CI 0.71 to 1.52; adjusted hazard ratio 0.56, 95% CI 0.29 to 1.08). There was no difference in survival rate at 24-hour (15.6% vs. 17.8%), at PICU, hospital, and 90-day post-discharge. No difference in other secondary outcomes was noted. CONCLUSION: A combination of Epinephrine plus Vasopressin did not improve the return of spontaneous circulation in pediatric intensive care cardiac arrest resuscitation

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Background and aims: The studies related to the psychiatric disorders in the mothers experience NICU have demonstrated high frequency of maternal stress, anxiety and postpartum depression (PPD). It is well known that maternal anxiety and depression adversely affect breastfeeding. The aim of this study was to examine the association between anxiety&depression status of NICU mothers and feeding type (exclusively breastfed (EBF) or mixed fed (MF)) of their infants within first week of life in NICU.

Methods: Data were collected from 93 mothers and 105 infants in a single-center, prospective, cross-sectional, descriptive study. The levels of anxiety and PPD were evaluated using the Spielberger State-Trait Anxiety Inventory (STAI) and Edinburgh Postnatal Depression Scale (EPDS).

Results: Breastfeeding exclusivity in NICU infants was significantly related to gestational age, birth weight, prenatal steroid and assisted reproductive technology (p=0.022, 0.041, 0.028, 0.017, respectively). The comparison of anxiety and depression scores of NICU mothers between EBF and MF groups revealed that STAI-T score was significantly high in EBF group than MF group (p=0.019). Logistic regression analyses showed that a one-unit increase in STAI-T score in NICU mothers was significantly associated with a 5.7% increase in the odds of breastfeeding exclusivity within first week in postpartum period (p:0.033)(OR = 1.057, 95% CI [1.004-1.113]).

Conclusions: Contrary to estimates, anxiety&depression status of NICU mothers do not affect negatively to breastfeeding exclusivity. Preterm infants under 32th gestational week and infants born after the pregnancy with assisted reproductive technology have a tendency to being EBF.