scholarly journals Using Late Supplemental Oxygen to Prevent Retinopathy of Prematurity Progression In Premature Infants: a Retrospective Study

2020 ◽  
Vol 3 ◽  
Author(s):  
Robert Minturn ◽  
Mary Beth Koch ◽  
Emily Anderson ◽  
Kok Lim Kua ◽  
Kathryn Haider

Background/Objective:  Retinopathy of Prematurity (ROP) is a leading causes of childhood blindness.  It affects 15,000 surviving US preterm infants annually, with 1,400 infants developing severe ROP and 500 infants developing legal blindness.  The pathogenesis of ROP involves 2 phases: During phase 1, the immature retinal vascularization is obliterated due to hyperoxia. During phase 2 (>4 weeks postnatally), abnormal neovascularization occurs due to hypoxia, sometimes requiring surgical intervention.   We retrospectively evaluated the impact of late supplemental oxygen (>4 weeks postnatally) on ROP progression in infants born <28 weeks.   Methods:  Preterm infants <28 weeks with >stage 2 ROP admitted to the Riley Hospital for Children Neonatal Intensive Care Unit (NICU) from 7/2017- 12/2019 were included. Nine patients treated with supplemental oxygen therapy were compared to a control cohort managed by a standard protocol after the diagnosis of stage 2 ROP.  The primary outcome was the need for surgical intervention with either laser or bevacizumab treatment. Continuous data was analyzed using unpaired t-test, and categorical data was analyzed using fishers exact test.   Results:  There was no statistical difference in regard to clinical variables contributing to risk of severe ROP (sex, race, birthweight necrotizing enterocolitis, bronchopulmonary dysplasia or length of stay) between the two study cohorts. There was a statistically significant decrease in need for treatments (laser or bevacizumab) in patients receiving supplemental oxygen (control: 35/83 patients treated, late O2: 0/9 patients treated, p=0.012).   Conclusion and Implications:  Supplemental oxygen therapy seems to have a protective effect on the development of treatable ROP (type I).  Limiting surgical intervention (laser or bevacizumab) would directly benefit the babies by decreasing the need for sedation and any inherent risks of surgery. This initial data suggests the need for future studies with a higher sample size to validate the efficacy of late supplemental O2 in ROP.       Study Group  Control       Number (Mean)  % (SD)  Number (Mean)  % (SD)  p-value  Population (N)  9  -  83  -     Sex              Male  2  22.2%  35  42.2%  N.S.  Female  7  77.8%  48  57.8%  N.S.  Race              Caucasian  5  55.6%  44  53.0%  N.S.  Non-Caucasian  4  44.4%  39  47.0%  N.S.  Birthweight (grams)  698  145.26  721  197.09  N.S.  Gestational Age (Weeks)  24.94  1.19  25.32  1.72  N.S.  Length of Stay (Days)  129.22  27.13  148.58  67.97  N.S.  Necrotizing Enterocolitis              Yes  3  33.3%  21  25.3%  N.S.  No  6  66.7%  62  74.7%  N.S.  Sepsis              Yes  6  66.7%  41  49.4%  N.S.  No  3  33.3%  42  50.6%  N.S.  Bronchopulmonary Dysplasia              Yes  9  100.0%  80  96.4%  N.S.  No  0  0.0%  2  2.4%  N.S.  Need for Additional Treatment (Inpatient)              Yes  0  0.0%  35  42.2%  N.S.  No  9  100.0%  48  57.8%  N.S.  Need for Additional Treatment (Outpatient)              Yes  0  0.0%  35  42.2%  0.012  No  9  100.0%  48  57.8%    

Author(s):  
Mathias A. Christensen ◽  
Jacob Steinmetz ◽  
George Velmahos ◽  
Lars S. Rasmussen

2013 ◽  
Vol 38 (4) ◽  
pp. 221-228 ◽  
Author(s):  
Anne Catherine van der Eijk ◽  
Denise Rook ◽  
Jenny Dankelman ◽  
Bert Johan Smit

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 198.2-199
Author(s):  
L. Pupim ◽  
T. S. Wang ◽  
K. Hudock ◽  
J. Denson ◽  
N. Fourie ◽  
...  

Background:Granulocyte/macrophage-colony stimulating factor (GM-CSF) is a cytokine both vital to lung homeostasis and important in regulating inflammation and autoimmunity1,2,3 that has been implicated in the pathogenesis of respiratory failure and death in patients with severe COVID-19 pneumonia and systemic hyperinflammation.4-6 Mavrilimumab is a human anti GM-CSF receptor α monoclonal antibody capable of blocking GM-CSF signaling and downregulating the inflammatory process.Objectives:To evaluate the effect of mavrilimumab on clinical outcomes in patients hospitalized with severe COVID-19 pneumonia and systemic hyperinflammation.Methods:This on-going, global, randomized, double-blind, placebo-controlled seamless transition Phase 2/3 trial was designed to evaluate the efficacy and safety of mavrilimumab in adults hospitalized with severe COVID-19 pneumonia and hyperinflammation. The Phase 2 portion comprised two groups: Cohort 1 patients requiring supplemental oxygen therapy without mechanical ventilation (to maintain SpO2 ≥92%) and Cohort 2 patients requiring mechanical ventilation, initiated ≤48 hours before randomization. Here, we report results for Phase 2, Cohort 1: 116 patients with severe COVID- 19 pneumonia and hyperinflammation from USA, Brazil, Chile, Peru, and South Africa; randomized 1:1:1 to receive a single intravenous administration of mavrilimumab (10 or 6 mg/kg) or placebo. The primary efficacy endpoint was proportion of patients alive and free of mechanical ventilation at Day 29. Secondary endpoints included [1] time to 2-point clinical improvement (National Institute of Allergy and Infectious Diseases COVID-19 ordinal scale), [2] time to return to room air, and [3] mortality, all measured through Day 29. The prespecified evidentiary standard was a 2-sided α of 0.2 (not adjusted for multiplicity).Results:Baseline demographics were balanced among the intervention groups; patients were racially diverse (43% non-white), had a mean age of 57 years, and 49% were obese (BMI ≥ 30). All patients received the local standard of care: 96% received corticosteroids (including dexamethasone) and 29% received remdesivir. No differences in outcomes were observed between the 10 mg/kg and 6 mg/kg mavrilimumab arms. Results for these groups are presented together. Mavrilimumab recipients had a reduced requirement for mechanical ventilation and improved survival: at day 29, the proportion of patients alive and free of mechanical ventilation was 12.3 percentage points higher with mavrilimumab (86.7% of patients) than placebo (74.4% of patients) (Primary endpoint; p=0.1224). Mavrilimumab recipients experienced a 65% reduction in the risk of mechanical ventilation or death through Day 29 (Hazard Ratio (HR) = 0.35; p=0.0175). Day 29 mortality was 12.5 percentage points lower in mavrilimumab recipients (8%) compared to placebo (20.5%) (p=0.0718). Mavrilimumab recipients had a 61% reduction in the risk of death through Day 29 (HR= 0.39; p=0.0726). Adverse events occurred less frequently in mavrilimumab recipients compared to placebo, including secondary infections and thrombotic events (known complications of COVID-19). Thrombotic events occurred only in the placebo arm (5/40 [12.5%]).Conclusion:In a global, diverse population of patients with severe COVID-19 pneumonia and hyperinflammation receiving supplemental oxygen therapy, corticosteroids, and remdesivir, a single infusion of mavrilimumab reduced progression to mechanical ventilation and improved survival. Results indicate mavrilimumab, a potent inhibitor of GM-CSF signaling, may have added clinical benefit on top of the current standard therapy for COVID-19. Of potential importance is that this treatment strategy is mechanistically independent of the specific virus or viral variant.References:[1]Trapnell, Nat Rev Dis Pri, 2019[2]Wicks, Nat Rev Immunology, 2015[3]Hamilton, Exp Rev Clin Immunol, 2015[4]De Luca, Lancet Rheumatol, 2020[5]Cremer, Lancet Rheumatol, 2021[6]Zhou, Nature, 2020Disclosure of Interests:Lara Pupim Employee of: Kiniksa, Shareholder of: Kiniksa, Tisha S. Wang Consultant of: Partner Therapeutics; steering committee for Kinevant BREATHE clinical trial, Kristin Hudock: None declared, Joshua Denson: None declared, Nyda Fourie: None declared, Luis Hercilla Vasquez: None declared, Kleber Luz: None declared, Mohammad Madjid Grant/research support from: Kiniksa, Kirsten McHarry: None declared, José Francisco Saraiva: None declared, Eduardo Tobar: None declared, Teresa Zhou Employee of: Kiniksa, Shareholder of: Kiniksa, Manoj Samant Employee of: Kiniksa, Shareholder of: Kiniksa, Joseph Pirrello Employee of: Kiniksa, Shareholder of: Kiniksa, Fang Fang Employee of: Kiniksa, Shareholder of: Kiniksa, John F. Paolini Employee of: Kiniksa, Shareholder of: Kiniksa, Arian Pano Employee of: Kiniksa, Shareholder of: Kiniksa, Bruce C. Trapnell: None declared


Author(s):  
Praveen S ◽  
Waris A

Retinopathy of prematurity (ROP) is an abnormal vascular proliferative disease of retina that affects preterm infants. It is a leading cause of childhood blindness worldwide despite improvement in neonatal care and management. Earlier ROP was found to be associated with oxygen therapy only. Now it was concluded that aetiology of ROP was multifactorial but three factors have shown significant association with ROP: low gestational age (GA), low birth weight (BW), prolonged exposure to supplementary oxygen following delivery. Several investigators reported that lower oxygen saturation targets at young post-gestational ages with increased oxygen saturation targets at older post gestational ages reduced the incidence of ROP. However previous clinical studies are not conclusive.


2018 ◽  
Vol 15 (7) ◽  
pp. 894-894
Author(s):  
Susan S. Jacobs ◽  
Kathleen O. Lindell ◽  
Eileen G. Collins ◽  
Chris M. Garvey ◽  
Carme Hernandez ◽  
...  

Heart ◽  
2018 ◽  
Vol 104 (20) ◽  
pp. 1691-1698 ◽  
Author(s):  
Nariman Sepehrvand ◽  
Stefan K James ◽  
Dion Stub ◽  
Ardavan Khoshnood ◽  
Justin A Ezekowitz ◽  
...  

BackgroundAlthough oxygen therapy has been used for over a century in the management of patients with suspected acute myocardial infarction (AMI), recent studies have raised concerns around the efficacy and safety of supplemental oxygen in normoxaemic patients.ObjectiveTo synthesise the evidence from randomised controlled trials (RCTs) that investigated the effects of supplemental oxygen therapy compared with room air in patients with suspected or confirmed AMI.MethodsFor this aggregate data meta-analysis, multiple databases were searched from inception to 30 September 2017. RCTs with any length of follow-up and any outcome measure were included if they studied the use of supplemental O2 therapy administered by any device at normal pressure compared with room air. Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, an investigator assessed all the included studies and extracted the data. Outcomes of interests included mortality, troponin levels, infarct size, pain and hypoxaemia.ResultsEight RCTs with a total of 7998 participants (3982 and 4002 patients in O2 and air groups, respectively) were identified and pooled. In-hospital and 30-day death occurred in 135 and 149 patients, respectively. Oxygen therapy did not reduce the risk of in-hospital (OR, 1.11 (95% CI 0.69 to 1.77)) or 30-day mortality (OR, 1.09 (95% CI 0.80 to 1.50)) in patients with suspected AMI, and the results remained similar in the subgroup of patients with confirmed AMI. The infarct size (based on cardiac MRI) in a subgroup of patients was not different between groups with and without O2 therapy. O2 therapy reduced the risk of hypoxaemia (OR, 0.29 (95% CI 0.17 to 0.47)).ConclusionAlthough supplemental O2 therapy is commonly used, it was not associated with important clinical benefits. These findings from eight RCTs support departing from the usual practice of administering oxygen in normoxaemic patients.


PEDIATRICS ◽  
1983 ◽  
Vol 71 (6) ◽  
pp. 913-917
Author(s):  
J. A. Smyth ◽  
I. L. Metcalfe ◽  
P. Duffty ◽  
F. Possmayer ◽  
M. H. Bryan ◽  
...  

Six preterm infants with severe hyaline membrane disease requiring ventilation were treated, at a median age of 15.5 hours, with a single intratracheal bolus of a bovine surfactant suspension. Arterial oxygenation increased dramatically, and chest radiograms showed improvement after two to four hours. However, a variable degree of deterioration occurred within 24 hours. All of the infants required oxygen therapy for several weeks, and one developed severe bronchopulmonary dysplasia.


2018 ◽  
Vol 59 (3) ◽  
pp. 1-8
Author(s):  
Elly Morros González ◽  
Diana Estrada Cano ◽  
Marcela Murillo Galvis ◽  
Jos Carlos Montes Correa ◽  
Nelcy Rodríguez Malagón ◽  
...  

Introduction: Supplemental oxygen is considered a pharmaceutical drug; therefore, it can produce adverse effects. Lack of consensus regarding the reading of oxygen flowmeters and the peripheral oxygen saturation (SpO2) goals can influence clinical and paraclinical decisions and hospital stay length. Objective: To assess knowledge on oxygen therapy, adverse effects, SpO2 goals and reading of oxygen flowmeters among personnel in the Pediatric Unit at Hospital Universitario San Ignacio, Bogotá, Colombia. Methodology: Cross-sectional study derived from convenience sampling through a self-applied survey between December 2016 and January 2017. The poll evaluated topics on supplemental oxygen therapy fundamentals and adverse effects, SpO2 goals and flowmeter readings through flowmeters photographs indicating a specific fraction of inspired oxygen (FiO2). Results: The response rate was 77% from 259 subjects. 22% considered that the oxygen saturation either increases or remains the same during sleep periods in children. 78% of participants knew at least one complication associated to prolonged oxygen therapy and 67% due to supplemental oxygen concentration greater than required. In neonatal population, 10% considered oxygen saturation goals equal to or greater than 96%. In the flowmeter’s reading evaluation, incorrect answers ranged from 9 to 19%. Conclusion: It is imperative to reinforce updated concepts on oxygen therapy, with emphasis in SpO2 goals, adverse effects and appropriate flowmeter’s readings through periodic educational campaigns.


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