scholarly journals Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Christian A. Maiwald ◽  
◽  
Hendrik J. Niemarkt ◽  
Christian F. Poets ◽  
Michael S. Urschitz ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Closed Loop ◽  
Target Range ◽  
Outcome Variable ◽  
Primary Outcome Variable ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Parallel Group ◽  
Extremely Preterm ◽  
Extremely Preterm Infants

Abstract Background Most extremely low gestational age neonates (ELGANS, postmenstrual age at birth (PMA) < 28 completed weeks) require supplemental oxygen and experience frequent intermittent hypoxemic and hyperoxemic episodes. Hypoxemic episodes and exposure to inadequately high concentrations of oxygen are associated with an increased risk of retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI), and death beyond 36 weeks PMA. Closed-loop automated control of the inspiratory fraction of oxygen (FiO2-C) reduces time outside the hemoglobin oxygen saturation (SpO2) target range, number and duration of hypo- and hyperoxemic episodes and caregivers’ workload. Effects on clinically important outcomes in ELGANs such as ROP, BPD, NEC, NDI and mortality have not yet been studied. Methods An outcome-assessor-blinded, randomized controlled, parallel-group trial was designed and powered to study the effect of FiO2-C (in addition to routine manual control (RMC) of FiO2), compared to RMC only, on death and severe complications related to hypoxemia and/or hyperoxemia. 2340 ELGANS with a GA of 23 + 0/7 to 27 + 6/7 weeks will be recruited in approximately 75 European tertiary care neonatal centers. Study participants are randomly assigned to RMC (control-group) or FiO2-C in addition to RMC (intervention-group). Central randomization is stratified for center, gender and PMA at birth (< 26 weeks and ≥ 26 weeks). FiO2-C is provided by commercially available and CE-marked ventilators with an FiO2-C algorithm intended for use in newborn infants. The primary outcome variable (composite of death, severe ROP, BPD or NEC) is assessed at 36 weeks PMA (or, in case of ROP, until complete vascularization of the retina, respectively). The co-primary outcome variable (composite outcome of death, language/cognitive delay, motor impairment, severe visual impairment or hearing impairment) is assessed at 24 months corrected age. Discussion Short-term studies on FiO2-C showed improved time ELGANs spent within their assigned SpO2 target range, but effects of FiO2-C on clinical outcomes are yet unknown and will be addressed in the FiO2-C trial. This will ensure an appropriate assessment of safety and efficacy before FiO2-C may be implemented as standard therapy. Trial registration The study is registered at www.ClinicalTrials.gov: NCT03168516, May 30, 2017.

DRAIN VERSUS NO DRAIN AFTER LAPAROSCOPIC CHOLECYSTECTOMY-A COMPARATIVE STUDY.

2021 ◽  
pp. 82-83
Author(s):  
Neelesh Bansal ◽  
Simran Simran ◽  
Debarshi Jana
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Comparative Study ◽  
Primary Outcome ◽  
Outcome Variable ◽  
Medical Sciences ◽  
Research Committee ◽  
Primary Outcome Variable ◽  
Drain Group ◽  
Calculate Sample Size ◽  
Site Pain

INTRODUCTION Gallstones are the most common conditions encountered in surgical OPD. The prevalence rose with age, except in women of 40-49 years, so that at 60-69 years, 22.4% of women and 11.5% of men had gall stones or had undergone cholecystectomy. With the help of this study, best treatment option for cholecystectomy patient (whether to insert drain or not), was ensured in terms of post lap cholecystectomy collections of bile or blood, drain site pain. The study was provide knowledge whether drain insertion was benecial or harmful to patient. MATERIALS AND METHODS This comparative study was presented to the surgery OPD and emergency department with cholelithiasis within a period of 1 year from the approval of Research committee and Ethics Committee, Adesh institute of medical sciences and research, Bathinda. The primary outcome variable used to calculate sample size is amount of collection on post-operative day 3(Quantitative Variable) in both groups. Total 100 patients were present in this study. RESULT In this present study VAS median grade in patients with drain was G4 (48%), followed by G3(47%) then G2(5%). VAS median grade in without drain group was G2 (48%), followed by G3(31%) and G1(16%). CONCLUSION There is no signicant difference as far as post operative wound infection in laparoscopic Cholecystectomy with drain or without drain. Therefore in patients undergoing laparoscopic cholecystectomy keeping drain can be avoided as it does not provide any additional benet.

scholarly journals A Comparison of 3 Vitamin D Dosing Regimens in Extremely Preterm Infants: A Randomized Controlled Trial

2016 ◽  
Vol 174 ◽  
pp. 132-138.e1 ◽  
Author(s):  
Prem Fort ◽  
Ariel A. Salas ◽  
Teodora Nicola ◽  
Carolyne M. Craig ◽  
Waldemar A. Carlo ◽  
...  
Keyword(s):  
Vitamin D ◽  
Randomized Controlled Trial ◽  
Preterm Infants ◽  
Controlled Trial ◽  
Randomized Controlled ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Dosing Regimens

scholarly journals Oxygen Saturation Target Range for Extremely Preterm Infants

2015 ◽  
Vol 169 (4) ◽  
pp. 332 ◽  
Author(s):  
Veena Manja ◽  
Satyan Lakshminrusimha ◽  
Deborah J. Cook
Keyword(s):  
Oxygen Saturation ◽  
Preterm Infants ◽  
Target Range ◽  
Extremely Preterm ◽  
Extremely Preterm Infants

scholarly journals Effect of Bias Gas Flow on Tracheal Cytokine Concentrations in Ventilated Extremely Preterm Infants: A Randomized Controlled Trial

Neonatology ◽  
2021 ◽  
pp. 1-8
Author(s):  
Katinka P. Bach ◽  
Carl A. Kuschel ◽  
Nicola Patterson ◽  
Hana Skwish ◽  
Sabine Huth ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Preterm Infants ◽  
Gas Flow ◽  
Controlled Trial ◽  
Tracheal Aspirate ◽  
Primary Outcome Measure ◽  
Gas Flows ◽  
Randomized Controlled ◽  
Extremely Preterm ◽  
Extremely Preterm Infants

<b><i>Background:</i></b> The objective of this study was to determine whether ventilator bias gas flow affects tracheal aspirate (TA) cytokine concentrations in ventilated extremely preterm infants. <b><i>Methods:</i></b> This is a randomized controlled trial in a tertiary neonatal unit in New Zealand. Preterm infants (&#x3c;28 weeks’ gestation/&#x3c;1,000 g) requiring intubation in the first 7 days after birth were randomized to bias gas flows of 4 or 10 L/min. Cytokine concentrations in TA and plasma were measured at 24, 72, and 120 h after the onset of ventilation. The primary outcome measure was concentration of interleukin (IL)-8 in TA 24 h after the onset of mechanical ventilation. <b><i>Results:</i></b> Baseline demographics were similar in babies randomized to 4 (<i>n</i> = 50) and 10 (<i>n</i> = 45) L/min bias gas flow. TA IL-8 concentrations were not different between groups. Plasma IL-8 concentrations decreased over time (<i>p</i> &#x3c; 0.05). Respiratory support and incidence of bronchopulmonary dysplasia at 36 weeks’ corrected gestational age were similar between groups. Fewer babies ventilated at 4 L/min developed necrotizing enterocolitis (NEC) ≥ stage 2 (<i>n</i> = 0 vs. <i>n</i> = 5; <i>p</i> = 0.02) and fewer died (<i>n</i> = 1 vs. <i>n</i> = 5, <i>p</i> = 0.06). <b><i>Conclusions:</i></b> Lower bias gas flow in ventilated extremely preterm infants did not alter TA cytokine concentrations but the lower incidence of NEC and mortality warrants further investigation.

scholarly journals Protocol for a randomised controlled trial comparing two CPAP levels to prevent extubation failure in extremely preterm infants

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e045897
Author(s):  
Anna Madeline Kidman ◽  
Brett James Manley ◽  
Rosemarie Anne Boland ◽  
Atul Malhotra ◽  
Susan M Donath ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Randomised Controlled Trial ◽  
Preterm Infants ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Extubation Failure ◽  
Intention To Treat ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Randomised Controlled

IntroductionRespiratory distress syndrome is a complication of prematurity and extremely preterm infants born before 28 weeks’ gestation often require endotracheal intubation and mechanical ventilation. In this high-risk population, mechanical ventilation is associated with lung injury and contributes to bronchopulmonary dysplasia. Therefore, clinicians attempt to extubate infants as quickly and use non-invasive respiratory support such as nasal continuous positive airway pressure (CPAP) to facilitate the transition. However, approximately 60% of extremely preterm infants experience ‘extubation failure’ and require reintubation. While CPAP pressures of 5–8 cm H2O are commonly used, the optimal CPAP pressure is unknown, and higher pressures may be beneficial in avoiding extubation failure. Our trial is the Extubation CPAP Level Assessment Trial (ÉCLAT). The aim of this trial is to compare higher CPAP pressures 9–11 cm H2O with a current standard pressures of 6–8 cmH2O on extubation failure in extremely preterm infants.Methods and analysis200 extremely preterm infants will be recruited prior to their first extubation from mechanical ventilation to CPAP. This is a parallel group randomised controlled trial. Infants will be randomised to one of two set CPAP pressures: CPAP 10 cmH2O (intervention) or CPAP 7 cmH2O (control). The primary outcome will be extubation failure (reintubation) within 7 days. Statistical analysis will follow standard methods for randomised trials on an intention to treat basis. For the primary outcome, this will be by intention to treat, adjusted for the prerandomisation strata (GA and centre). We will use the appropriate parametric and non-parametric statistical tests.Ethics and disseminationEthics approval has been granted by the Monash Health Human Research Ethics Committees. Amendments to the trial protocol will be submitted for approval. The findings of this study will be written into a clinical trial report manuscript and disseminated via peer-reviewed journals (on-line or in press) and presented at national and international conferences.Trial registration numberACTRN12618001638224; pre-results.

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