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OBJECTIVE: To determine if providing respiratory support to very preterm infants who fail to breathe regularly during deferred cord clamping (DCC) decreased red cell transfusion. STUDY DESIGN: Infants less than 31 weeks of gestation undergoing DCC who were apneic or not breathing regularly at 15 seconds underwent stratified randomization. Pale, limp, and nonresponsive infants were excluded. The standard group received gentle stimulation in a neutral position for 50 seconds; the intervention group received intermittent positive pressure ventilation via face mask and T piece from 20 to 50 seconds of age with a fractional inspired oxygen of 0.3. The primary outcome was the proportion transfused, with a secondary composite outcome of death, severe intraventricular hemorrhage, or chronic lung disease. RESULTS: Of 311 assessed infants, 113 met the inclusion criteria and were studied; 57 received the intervention and 56 standard treatment. Patient characteristics were similar. Overall, 105 infants (93%) received the intended 50 seconds DCC (54 in the intervention group and 51 in the standard group). Rates of transfusion were similar (28% vs 30% in the intervention vs control groups), as were rates of the composite outcome (46% vs 38% in the intervention vs the control arms; P = .45). CONCLUSIONS: Providing breathing support during 50 seconds of DCC in this single-center cohort seemed to be safe and feasible, but did not decrease the transfusion rates or improve outcomes. TRIAL REGISTRATION: http://www.anzctr.org.au/ACTRN12615001026516.aspx.

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OBJECTIVE: To improve health-related physical fitness (HRPF) (primary outcome) and health-related quality of life (HRQoL) with a web-based motor intervention program in pediatric patients with congenital heart disease (CHD). STUDY DESIGN: Overall, 70 patients (13.0 ± 2.6 years; 34% girls) aged 10-18 years with moderate or complex CHD severity were randomly allocated 1:1 to an intervention or control group. The intervention group trained 3 times per week for 20 minutes in a web-based exercise program over a period of 24 weeks. The control group followed lifestyle per usual. At baseline and follow-up HRPF was assessed via 5 tasks of the FITNESSGRAM and converted to a HRPF z score. HRQoL was assessed with KINDL self-report questionnaire. RESULTS: In total, 61 patients completed the follow-up. There was no change in total HRPF z score (intervention group: 0.14 ± 0.38 vs control group: 0.09 ± 0.38, P = .560) and total HRQoL (intervention group: -1.73 ± 8.33 vs control group: 1.31 ± 7.85, P = .160) after the 24-week web-based exercise intervention. This was true for all subcategories of HRPF and HRQoL. There were no adverse events associated with the web-based exercise intervention. CONCLUSIONS: We found that 24 weeks of web-based exercise intervention with an aimed volume of 60 minutes of exercise per week was safe but did not improve HRPF and HRQoL in children with moderate or complex CHD. TRIAL REGISTRATION: Clinicaltrials.gov: NCT03488797.

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OBJECTIVE: To compare daily physical activity of children with congenital heart disease (CHD) with healthy peers measured using wearables bracelets in a large cohort. Additionally, subjectively estimated and objectively measured physical activity was compared. STUDY DESIGN: From September 2017 to May 2019, 162 children (11.8 ± 3.2 years; 60 girls) with various CHD participated in a self-estimated and wearable-based physical activity assessment. Step-count and moderate-to-vigorous physical activity were recorded with the Garmin vivofit jr. for 7 consecutive days and compared with a reference cohort (RC) of 96 healthy children (10.9 ± 3.8 years; 49 girls). RESULTS: Children with CHD were active and 123 (75.9%) achieved 60 minutes physical activity on a weekly average according to the World Health Organization criteria as 81 (84.3%) of the healthy peers did (P = .217). After correction for age, sex, and seasonal effects, only slightly lower step count (CHD: 10 206 ± 3178 steps vs RC: 11 142 ± 3136 steps; P = .040) but no lower moderate-to-vigorous physical activity (CHD: 80.5 ± 25.6 minutes/day vs RC: 81.5 ± 25.3 minutes/day; P = .767) occurred comparing CHD with RC. In children with CHD higher age (P = .004), overweight or obesity (P = .016), complex severity (P = .046), and total cavopulmonary connection (P = .027) were associated with not meeting World Health Organization criteria. Subjective estimation of daily moderate-to-vigorous physical activity was fairly correct in half of all children with CHD. CONCLUSIONS: Even though the majority is sufficiently active, physical activity needs to be promoted in overweight or obese patients, patients with complex CHD severity, and in particular in those with total cavopulmonary connection.

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Background and Purpose- The role of aspirin plus clopidogrel (A+C) therapy compared with aspirin monotherapy in patients presenting with acute ischemic stroke (IS) or transient ischemic attack remains uncertain. We conducted this study to determine the optimal period of efficacy and safety of A+C compared with aspirin monotherapy. Methods- Ten randomized controlled trials (15 434 patients) were selected using MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL) (inception June 2018) comparing A+C with aspirin monotherapy in patients with transient ischemic attack or IS. The primary efficacy outcome was recurrent IS, and the primary safety outcome was major bleeding. The secondary outcomes were major adverse cardiovascular events (composite of stroke, myocardial infarction, and cardiovascular mortality) and all-cause mortality. We stratified analysis based on the short- (≤1 month), intermediate- (≤3 month), and long-term (>3 month) A+C therapy. Effects were estimated as relative risk (RR) with 95% CI. Results- A+C significantly reduced the risk of recurrent IS at short-term (RR, 0.53; 95% CI, 0.37-0.78) and intermediate-term (RR, 0.72; 95% CI, 0.58-0.90) durations. Similarly, major adverse cardiovascular event was significantly reduced by short-term (RR, 0.68; 95% CI, 0.60-0.78) and intermediate-term (RR, 0.76; 95% CI, 0.61-0.94) A+C therapy. However, long-term A+C did not yield beneficial effect in terms of recurrent IS (RR, 0.81; 95% CI, 0.63-1.04) and major adverse cardiovascular events (RR, 0.87; 95% CI, 0.71-1.07). Intermediate-term (RR, 2.58; 95% CI, 1.19-5.60) and long-term (RR, 1.87; 95% CI, 1.36-2.56) A+C regimens significantly increased the risk of major bleeding as opposed to short-term A+C (RR, 1.82; 95% CI, 0.91-3.62). Excessive all-cause mortality was limited to long-term A+C (RR, 1.45; 95% CI, 1.10-1.93). Conclusions- Short-term A+C is more effective and equally safe in comparison to aspirin alone in patients with acute IS or transient ischemic attack.

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OBJECTIVE: To investigate whether exposure to inhibitors of gastric acidity, such as H2 blockers or proton pump inhibitors, can independently increase the risk of infections in very low birth weight (VLBW) preterm infants in the neonatal intensive care unit. STUDY DESIGN: This is a secondary analysis of prospectively collected data from a multicenter, randomized controlled trial of bovine lactoferrin (BLF) supplementation (with or without the probiotic Lactobacillus rhamnosus GG) vs placebo in prevention of late-onset sepsis (LOS) and necrotizing enterocolitis (NEC) in preterm infants. Inhibitors of gastric acidity were used at the recommended dosages/schedules based on the clinical judgment of attending physicians. The distribution of days of inhibitors of gastric acidity exposure between infants with and without LOS/NEC was assessed. The mutually adjusted effects of birth weight, gestational age, duration of inhibitors of gastric acidity treatment, and exposure to BLF were controlled through multivariable logistic regression. Interaction between inhibitors of gastric acidity and BLF was tested; the effects of any day of inhibitors of gastric acidity exposure were then computed for BLF-treated vs -untreated infants. RESULTS: Two hundred thirty-five of 743 infants underwent treatment with inhibitors of gastric acidity, and 86 LOS episodes occurred. After multivariate analysis, exposure to inhibitors of gastric acidity remained significantly and independently associated with LOS (OR, 1.03; 95% CI, 1.008-1.067; P = .01); each day of inhibitors of gastric acidity exposure conferred an additional 3.7% odds of developing LOS. Risk was significant for Gram-negative (P < .001) and fungal (P = .001) pathogens, but not for Gram-positive pathogens (P = .97). On the test for interaction, 1 additional day of exposure to inhibitors of gastric acidity conferred an additional 7.7% risk for LOS (P = .003) in BLF-untreated infants, compared with 1.2% (P = .58) in BLF-treated infants. CONCLUSION: Exposure to inhibitors of gastric acidity is significantly associated with the occurrence of LOS in preterm VLBW infants. Concomitant administration of BLF counteracts this selective disadvantage. TRIAL REGISTRATION: isrctn.org: ISRCTN53107700.

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OBJECTIVES: The interfacility transport of pediatric patients requires a highly skilled and well-trained workforce, of which little is known. The primary study purpose was to characterize the current state of pediatric interfacility transport in the United States including, but not limited to, which team models predominate, what team configurations are used, team training standards, and the use of quality assurance metrics. METHODS: A descriptive and qualitative Web-based survey questionnaire was developed. Potential participants were identified, and 1 survey was completed per team. RESULTS: In total, 179 teams with pediatric transport capabilities were identified, and 111 responses were recorded (response rate, 62%), of which dedicated teams comprised 77% and unit-based teams comprised 16%. Over 98% reported using a registered nurse as a team member, in comparison to 66% for respiratory therapists and 42% for paramedics. Less than 5% reported utilizing an associate level provider or physician for pediatric transports. The most common team composition was a registered nurse-respiratory therapist combination (30%). Over 55% of the respondents reported performing less than 500 pediatric transports per year. Quality assurance activities were performed by 96% of the respondents. CONCLUSIONS: The team composition and training for interfacility transport of pediatric patients is a complex and not well-characterized process; furthermore, the varying organizational models, team composition, and training requirements for teams have not been previously reported. These results will aid in the future development of team standards for pediatric transport and help guide further improvements in this field.

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This study showed that thermally labile fibrillar collagen could be processed continuously in combination with gelatine as foaming additive by convection drying. The procedure led to stable sponges with similar structural and physical properties as found for freeze-dried collagen samples. The fibrillar collagen remained native, while gelatine acted as foaming additive. The absorbency of the sponges was improved by opening the surface with abrasives. A use as medical device with hemostyptic properties would be possible.

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OBJECTIVE: To assess whether the addition of heated humidified gas (HHG) at delivery and until neonatal unit arrival improved admission temperatures of preterm infants. STUDY DESIGN: This multicenter, randomized controlled trial was performed in New Zealand and The Netherlands. Infants <32 weeks' gestation who required respiratory support after delivery were randomized to either cold, dry gas or HHG from birth. Standard measures to prevent hypothermia included heated delivery rooms, the use of radiant warmers, body wrap, and head covering. The primary outcome was axillary temperature in the normothermic (36.5-37.5°C) range on admission to a neonatal intensive care unit. Secondary outcomes were measures of respiratory support and neonatal morbidities. The effect of humidification was analyzed by the use of logistic regression. RESULTS: Of 203 randomized infants, 100 received HHG (humidifier set to 37°C) and 103 received cold, dry gas. In the HHG group, 69 (69%) were normothermic compared with 57 (55%) in the cold, dry gas group (unadjusted OR 1.8, 95% CI 1.01-3.19). A greater number of infants <28 weeks were normothermic on admission in the HHG group (24/35; ie, 69%) compared with the cold, dry gas group (16/38; ie, 42%; P = .03). In addition, 2 (2%) infants in the HHG group had admission temperatures <35.5°C compared with 12 (12%) in the cold, dry gas group (P = .007). Respiratory and short-term outcomes were not different. CONCLUSION: Adding HHG during respiratory support in preterm infants from birth increased the incidence of normothermia at admission.

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OBJECTIVE: To assess whether an oxygen saturation (Spo2) target of 85%-89% compared with 91%-95% reduced the incidence of the composite outcome of death or major disability at 2 years of age in infants born at <28 weeks' gestation. STUDY DESIGN: A total 340 infants were randomized to a lower or higher target from <24 hours of age until 36 weeks' gestational age. Blinding was achieved by targeting a displayed Spo2 of 88%-92% using a saturation monitor offset by ±3% within the range 85%-95%. True saturations were displayed outside this range. Follow-up at 2 years' corrected age was by pediatric examination and formal neurodevelopmental assessment. Major disability was gross motor disability, cognitive or language delay, severe hearing loss, or blindness. RESULTS: The primary outcome was known for 335 infants with 33 using surrogate language information. Targeting a lower compared with a higher Spo2 target range had no significant effect on the rate of death or major disability at 2 years' corrected age (65/167 [38.9%] vs 76/168 [45.2%]; relative risk 1.15, 95% CI 0.90-1.47) or any secondary outcomes. Death occurred in 25 (14.7%) and 27 (15.9%) of those randomized to the lower and higher target, respectively, and blindness in 0% and 0.7%. CONCLUSIONS: Although there was no benefit or harm from targeting a lower compared with a higher saturation in this trial, further information will become available from the prospectively planned meta-analysis of this and 4 other trials comprising a total of nearly 5000 infants.

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