Oxygen Saturation Targets And Outcomes In Extremely Preterm Infants Pdf
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- Targeting lower or higher oxygen levels in preterm infants
- Oxygen Saturation Targets in Preterm Infants and Outcomes at 18–24 Months: A Systematic Review
- Is There a “Right” Amount of Oxygen for Preterm Infant Stabilization at Birth?
Targeting lower or higher oxygen levels in preterm infants
To systematically review evidence evaluating the effect of restricted vs liberal oxygen exposure on morbidity and mortality in extremely preterm infants. All meta-analyses were performed using Review Manager 5. The Cochrane risk-of-bias tool was used to assess study quality. The summary of the findings and the level of confidence in the estimate of effect were assessed using GRADEpro.
Treatment effect was analyzed using a random-effects model. Death before hospital discharge, death or severe disability before 24 months, death before 24months, neurodevelopmental outcomes, hearing loss, bronchopulmonary dysplasia, necrotizing enterocolitis, and severe retinopathy of prematurity.
Five trials were included in the final synthesis. Mortality before 24 months was not different RR, 1. The rates of bronchopulmonary dysplasia, neurodevelopmental outcomes, hearing loss, and retinopathy of prematurity were similar between the 2 groups.
Necrotizing enterocolitis occurred more frequently in infants on restricted oxygen RR, 1. Although infants cared for with a liberal oxygen target had significantly lower mortality before hospital discharge than infants cared for with a restricted oxygen target, the quality of evidence for this estimate of effect is low. Necrotizing enterocolitis occurred less frequently in the liberal oxygen group.
We found no significant differences in death or disability at 24 months, bronchopulmonary dysplasia, retinopathy of prematurity, neurodevelopmental outcomes, or hearing loss at 24 months. Although oxygen is crucial for survival, too much oxygen can be harmful. Monitoring and maintaining optimal oxygen saturation SpO 2 by pulse oximetry is a critical component of treating respiratory diseases.
Published literature regarding the harm from excess oxygen in neonates is especially compelling. In the past several decades, improvements in technology have led to the increased survival of extremely premature infants. The methods for measuring oxygenation have also improved, enabling precise titration of oxygen delivery. However, the optimal SpO 2 target in extremely premature infants has been debated for many years with varying results in previous randomized and observational studies, leading to significant uncertainty.
Although the complications of hyperoxia were reduced in the low range of SpO 2 , some of these studies demonstrated an increased mortality and have generated controversy. To add to the controversy, an audit of the pulse oximeter used in these trials 15 revealed an artifact in the algorithm. This artifact would be expected to reduce the number of SpO 2 values in the target range for the lower saturation target group 18 and potentially reduce the separation between the groups.
This artifact may affect the results and will be explored in a subgroup analysis in this review. A recently published meta-analysis of optimal oxygenation of extremely low birth weight infants included these trials. All published RCTs and submitted abstracts with sufficient information, irrespective of language of publication, publication year, publication type, and publication status, were eligible for inclusion in our review.
The outcome measures included any of the following: death before hospital discharge, death or severe disability before 24 months, death before 24 months, neurodevelopmental outcomes, hearing loss, bronchopulmonary dysplasia, necrotizing enterocolitis, and severe ROP.
Previous reviews, including cross references and bibliographic citations of relevant publications, were reviewed. Ongoing trials were searched on ClinicalTrial. The titles and abstracts of potentially relevant publications retrieved by the search were reviewed independently by 2 reviewers V. If a review of an abstract led to disagreement about eligibility of the study for inclusion, it was included for the full text review.
Full text articles of the selected citations were reviewed by the 2 reviewers independently, and eligible studies were included in the systematic review. For excluded articles, the reason for exclusion was recorded. Any discordance was identified; disagreement was resolved by discussion and consensus without a third reviewer.
Data were abstracted independently by the 2 reviewers on a data abstraction form prepared specifically for this review. Any differences and disagreements in the abstracted data were discussed and resolved by consensus. Details of methodological quality, study design, analysis, and results were abstracted. For each outcome, the numeric results, the statistic used, and the P value were abstracted.
Critical appraisal and assignment of a quality of evidence for the included studies were conducted independently by the 2 reviewers. All discrepancies were resolved by discussion and consensus. In addition to assessing the risk of bias for each study, we assessed the quality of the evidence to support the estimate of effect for each outcome using GRADEpro. With the use of this method, an overall assessment of the quality of evidence is made for each outcome across all included studies.
Randomized clinical controlled trials start out as high-level evidence; however, downgrading of the level of evidence can occur because of deficiencies in 1 or more of the following domains: risk of bias, 22 inconsistency, 23 indirectness, 24 imprecision, 25 and publication bias. A summary of findings with quality of evidence for estimates with reasons for quality assignment is presented for each outcome Table.
We are still awaiting the final reports of 2 major trials. We were unable to obtain further information regarding the missing data from the existing literature. We did not contact the primary investigators for the missing data. No imputations were performed. We used complete available-case analysis for all outcomes. Clinical heterogeneity was explored by comparing the patient populations, the variations, if any, in study methods, and the oxygenation targets.
Heterogeneity was also assessed by the I 2 statistic for each meta-analysis. The results using a fixed-effects model were explored in a sensitivity analysis. After title and abstract review, 54 articles were included for full text review.
There was no disagreement in the selection of the final articles for the systematic review. Five trials were included in this review.
The eTable in the Supplement provides a brief description of the trials and the primary, secondary, and post hoc outcomes. The exact postnatal age at inclusion and the lower limit of gestation differed slightly. The gestational age at randomization was between 24 weeks, 0 days and 27 weeks, 6 days. In COT, infants with a PMA of 23 weeks, 0 days through 27 weeks, 6 days were eligible for enrollment during the first 24 hours after birth.
Using the Cochrane risk-of-bias assessment, we found that, overall, these studies were all at low risk of bias for sequence generation, concealment of allocation, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective outcome reporting. Our Table is a summary of the findings.
The reason for downgrading the quality of evidence for each outcome is explained in the table footnotes. One justification for decreasing the quality of evidence across all outcomes to moderate is the fact that, although a distinct separation of SpO 2 was planned in the study protocols, there was significant overlap in the SpO 2 values achieved in the 2 groups Figure 1 , 19 resulting in significant crossover of infants in the intervention and comparator groups.
The level of confidence in the estimate for death before hospital discharge was downgraded further to low because this was not a prespecified primary outcome in any of the trials. Initially, the 2 reviewers disagreed. The quality of evidence was rated moderate by S. The quality of evidence for ROP was downgraded to low owing to the inconsistency of results between the studies.
This figure was adapted from Figure 4 in Lakshminrusimha et al. Forest plots for individual outcomes are shown in Figure 2 , Figure 3 , and Figure 4. These demonstrate unadjusted RRs. The adjusted RRs corrected for factors such as study center, gestational age groups, and multiple births cited in the original studies are different from the RRs shown in these plots.
The numbers shown in this plot are raw, unadjusted values and differ from the adjusted risk ratios provided in the references. Death before hospital discharge was not a prespecified outcome in these trials. The RR for this outcome is 1. The numbers of infants who died before 24 months ie, the outcome of death before 24 months were not significantly different between the 2 groups RR, 1.
The numbers of infants who developed bronchopulmonary dysplasia at 36 weeks were not significantly different between the 2 groups RR, 0. Necrotizing enterocolitis occurred significantly more frequently in the restricted oxygen group than in the liberal oxygen group RR, 1. The numbers of adverse neurodevelopmental outcomes at 24 months, determined by use of the modified Gross Motor Function Classification System RR, 1. The numbers of infants with hearing loss at approximately 24 months RR, 1.
The numbers of infants who developed severe ROP were not significantly different between the 2 groups for the pooled result using the random-effects model RR, 0. There was significant heterogeneity among trials for this outcome. The Q statistic had a P value of. Owing to unexplained heterogeneity, the level of confidence in this estimate was downgraded by 1 for inconsistency for this outcome. The data were insufficient to perform subgroup analysis based on sex, mode of delivery, and oximeter algorithm.
Data on sex and mode of delivery were not reported separately in these studies. Outcomes based on oximeter-algorithm assignment were not available for similar time points. The COT provided the breakdown based on the oximeter algorithm original vs modified for outcomes at 18 months; the BOOST II trial, on the other hand, provided these data during the index hospitalization only. As part of the sensitivity analysis, all outcomes were evaluated using the fixed-effect model.
The random- and fixed-effects models assign study weights differently, which results in varying the influence of individual studies on the final result. The fixed-effects model assigns weight based on the size of the study and largely ignores the information in smaller studies. Because ROP was less frequent in the restricted oxygen group than in the liberal oxygen group in the BOOST II trial, the change in weighting moved the overall estimate of effect away from the center, resulting in a statistically significant difference between the 2 groups.
Our goal was to estimate the mean effect in all 3 studies and not let the overall estimate be overly influenced by 1 study the BOOST II trial.
In addition, our goal was to generalize the results to a range of clinical scenarios, and the random-effects model is more suitable for this purpose. Results did not differ significantly using the fixed-effects model for any of the other outcomes.
This systematic review summarizes the results of recent RCTs that compare 2 different SpO 2 target ranges and explicitly ranks the quality of the evidence supporting each outcome using the internationally accepted GRADE criteria. Using the summary estimates of the meta-analysis conducted as part of this review, we found that, although there were higher frequencies of necrotizing enterocolitis and death prior to hospital discharge in the restricted oxygen group, there were no differences in the other outcomes between the 2 groups.
Oxygen Saturation Targets in Preterm Infants and Outcomes at 18–24 Months: A Systematic Review
Skip to search form Skip to main content You are currently offline. Some features of the site may not work correctly. DOI: Manja and O. Saugstad and S.
In phase 3, oxygen saturation histograms constructed from pulse-oximeter data were used as daily feedback to nurses and compliance with oxygen-targeting was measured again. The mean SD percent time spent within target SpO 2 range increased from Effective implementation of oxygen targeting policy and feedback using oxygen saturation histograms may improve compliance with oxygen targeting. This is a preview of subscription content, access via your institution. Rent this article via DeepDyve. Stenson BJ. J Perinatol.
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Is There a “Right” Amount of Oxygen for Preterm Infant Stabilization at Birth?
Recent clinical practice changes in neonatal care resulted in higher, narrower oxygen saturation target ranges for preterm infants. The effect of targeting higher or lower oxygen saturations on respiratory outcomes of preterm infants and duration of hospitalization has not been extensively reviewed in the context of current care, but could have significant implications. The primary outcome was bronchopulmonary dysplasia BPD. Secondary outcomes were evaluated with survival analysis and Wilcoxon rank sum test.
Jump to navigation. Review question : Is it better to target a lower or higher level of oxygen for babies born very early? Background : Giving additional 'supplemental' oxygen to babies born very early 'extremely preterm infants' who have breathing difficulties has been common practice since the s. Despite this, there is little agreement as to what levels of oxygen will maximise short- or long-term survival and development. Technology 'pulse oximetry' that can easily measure the level of oxygen in a baby's blood oxygen saturation has been in widespread use since the s.
The Spanish Association of Pediatrics has as one of its main objectives the dissemination of rigorous and updated scientific information on the different areas of pediatrics. Annals of Pediatrics is the Body of Scientific Expression of the Association and is the vehicle through which members communicate. The Impact Factor measures the average number of citations received in a particular year by papers published in the journal during the two receding years. CiteScore measures average citations received per document published.
The amount of oxygen given to preterm infants within the first few minutes of birth is one of the most contentious issues in modern neonatology.
Бедолага. Беккер ничего не сказал и продолжал разглядывать пальцы умершего. - Вы уверены, что на руке у него не было перстня. Офицер удивленно на него посмотрел. - Перстня. - Да.
Потом он подумал о вирусе, попавшем в ТРАНСТЕКСТ, о Дэвиде Беккере в Испании, о своих планах пристроить черный ход к Цифровой крепости. Он так много лгал, он так виноват. Стратмор знал, что это единственный способ избежать ответственности… единственный способ избежать позора. Он закрыл глаза и нажал на спусковой крючок. Сьюзан услышала глухой хлопок, когда уже спустилась на несколько пролетов .
Он торопливо повернул выключатель. Стекла очков блеснули, и его пальцы снова задвигались в воздухе. Он, как обычно, записал имена жертв.
Это цена, которую приходится платить за известность. - Действительно.