Supplemental oxygen strategies in infants with bronchopulmonary dysplasia after the neonatal intensive care unit period:study protocol for a randomised controlled trial (SOS BPD study)

Introduction Supplemental oxygen is the most important treatment for preterm born infants with established bronchopulmonary dysplasia (BPD). However, it is unknown what oxygen saturation levels are optimal to improve outcomes in infants with established BPD from 36 weeks postmenstrual age (PMA) onwards. The aim of this study is to compare the use of a higher oxygen saturation limit (≥95%) to a lower oxygen saturation limit (≥90%) after 36 weeks PMA in infants diagnosed with moderate or severe BPD. Methods and analysis This non-blinded, multicentre, randomised controlled trial will recruit 198 preterm born infants with moderate or severe BPD between 36 and 38 weeks PMA. Infants will be randomised to either a lower oxygen saturation limit of 95% or to a lower limit of 90%; supplemental oxygen and/or respiratory support will be weaned based on the assigned lower oxygen saturation limit. Adherence to the oxygen saturation limit will be assessed by extracting oxygen saturation profiles from pulse oximeters regularly, until respiratory support is stopped. The primary outcome is the weight SD score at 6 months of corrected age. Secondary outcomes include anthropometrics collected at 6 and 12 months of corrected age, rehospitalisations, respiratory complaints, infant stress, parental quality of life and cost-effectiveness. Ethics and dissemination Ethical approval for the trial was obtained from the Medical Ethics Review Committee of the Erasmus University Medical Centre, Rotterdam, the Netherlands (MEC-2018-1515). Local approval for conducting the trial in the participating hospitals has been or will be obtained from the local institutional review boards. Informed consent will be obtained from the parents or legal guardians of all study participants

Technical validity and usability of a novel smartphone-connected spirometry device for pediatric patients with asthma and cystic fibrosis

Background: Diagnosis and follow-up of respiratory diseases traditionally rely on pulmonary function tests (PFTs), which are currently performed in hospitals and require trained personnel. Smartphone-

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The efficacy and toxicity of aminoglycosides show a strong direct positive relationship with blood drug concentrations, therefore, therapy with aminoglycosides in adults is usually guided by therapeutic drug monitoring. Dosing regimens in adults have evolved from multiple daily dosing to extended-interval dosing. This evolution has also taken place in neonates. Neonates, however, display large interindividual differences in the pharmacokinetics of aminoglycosides due to developmental differences early in life. The volume of distribution of aminoglycosides shows a strong relationship with bodyweight, which tends to be larger (corrected for bodyweight) in more premature infants and those with sepsis. Renal clearance of aminoglycosides increases with gestational age and accelerates immediately after birth. Because of these developmental influences, there is great inter- and intraindividual variability in the volume of distribution and clearance of these drugs, and investigators have established aminoglycoside dosing regimens based on bodyweight and/or gestational age. Widely practised dosing regimens comprise 4-5 mg/kg bodyweight of gentamicin every 24-48 hours as a first dose, followed by dose adjustment based on therapeutic drug monitoring. Although formal toxicity studies are scarce, there is no evidence that aminoglycoside toxicity in neonates differs from that in adults. Monitoring of blood drug concentrations and intelligent reconstruction of individual pharmacokinetic behaviour using a population pharmacokinetic model, optimally chosen blood sampling times and appropriate pharmacokinetic software, help clinicians to quickly optimize aminoglycoside dosing regimens to maximize the clinical effect and minimize the toxicity of these drugs

Extended-Interval Dosing of Gentamicin Aiming for a Drug-Free Period in Neonates:A Prospective Cohort Study

Background:Current gentamicin dosing algorithms in adult populations target a high peak concentration (C-max) assuring efficacy and a drug-free period (concentration 8 mgL(-1) and estimated trough concentrations 8 mgL(-1) with a C-min valu

Association between colonization with Group B Streptococcus and preterm delivery: A systematic review

Up to 36% of pregnant women are colonized with Group B Streptococcus (GBS). Preterm delivery in colonized mothers is a risk factor for early onset neonatal GBS disease, but whether maternal GBS genital colonization is related to preterm delivery is unclear. The objective of this review was to determine the relationship between maternal colonization with GBS and preterm delivery. Pubmed searches and reference lists of all selected publications were used to find studies reporting on the relationship between maternal GBS colonization and preterm delivery. Study characteristics were abstracted, and validity scores were performed. To assess the relationship between GBS colonization and pregnancy outcome, four-fold prognostic tables were constructed for each study. Out of more than 60 full-text articles, 16 follow-up studies and four case control studies were included in this review. Follow-up studies were divided into 'cohort studies,' in which cultures were taken early in pregnancy and which reported on pregnancy outcome, and 'cross-sectional studies', in which cultures were collected during delivery. Studies differed widely in methods, validity score, and GBS prevalence. The combined estimate from a random effect meta-analysis of the 11 cohort studies was 1.06 (95% confidence intervals (CI) 0.95-1.19) and for the five cross-sectional studies 1.75 (95% CI 1.43-2.14). For the case control studies, the pooled odds ratio was 1.59 (95% CI 1.03-2.44). This systematic review did not show an association between maternal GBS colonization during pregnancy and preterm delivery. However, in case of preterm delivery, there is an increased risk of subsequent maternal GBS colonization