Steroid Use for Established Bronchopulmonary Dysplasia: Study Protocol for a Systematic Review and Meta-analysis.

Author(s):  
Sabina Strashun ◽  
Joanna Seliga-Siwecka ◽  
Roberto Chioma ◽  
Alessandra Rossi ◽  
Kinga Zielińska ◽  
...  

Abstract BackgroundBronchopulmonary dysplasia (BPD) is a serious chronic respiratory condition that affects approximately 60% of preterm infants born before 27 weeks’ gestation, and leads to both, short and long-term pulmonary and non-pulmonary complications. Infants suffering from BPD are difficult to wean off of respiratory support, delaying feeding advancement and hospital discharge. Postnatal steroids during the first three weeks of life have been demonstrated to be effective in decreasing the incidence of BPD, however concerns in relation to neurodevelopmental outcomes are reported as well. On the contrary, data regarding the use of late postnatal steroids, once BPD is established are sparse and inconsistent. Here, we report a protocol for a systematic review, which aims to determine the efficacy and long-term safety of post-natal steroids for the treatment of established BPD in preterm infants.MethodsMEDLINE, Embase, Cochrane databases and sources of grey literature will be searched with no time or language restriction for studies that evaluated the use of postnatal steroids for preterm infants with established BPD. Odds ratios and 95% confidence intervals will be determined and pooled using a random effects model. For the studies that cannot be combined in the meta-analysis, a narrative synthesis of the results will be provided. DiscussionThe use of steroids as a therapeutic option for established BPD, after reaching the critical phase of the disease, is limited by the concern of possible neurological side effects that were documented for the preventive use of this medication. However, steroid treatment for established BPD may be administered in an attempt to reduce length of stay and home oxygen therapy, which are both associated with high levels of parental stress and healthcare costs. Moreover, a late timing for steroid treatment may show a more favourable safety profile in terms of neurodevelopment outcomes, considering the added postnatal brain maturation of these infants. As BPD is one of the neonatal complications that lack an effective course-modifying treatment approach to-date, the proposed systematic review offers considerable clinical relevance.Systematic review registration The protocol is registered in the PROSPERO register (registration number CRD42021218881).

Children ◽  
2019 ◽  
Vol 6 (12) ◽  
pp. 131 ◽  
Author(s):  
Shirley Cai ◽  
Deanne K. Thompson ◽  
Peter J. Anderson ◽  
Joseph Yuan-Mou Yang

Sepsis is commonly experienced by infants born very preterm (<32 weeks gestational age and/or <1500 g birthweight), but the long-term functional outcomes are unclear. The objective of this systematic review was to identify observational studies comparing neurodevelopmental outcomes in very preterm infants who had blood culture-proven neonatal sepsis with those without sepsis. Twenty-four studies were identified, of which 19 used prespecified definitions of neurodevelopmental impairment and five reported neurodevelopmental outcomes as continuous variables. Meta-analysis was conducted using 14 studies with defined neurodevelopmental impairment and demonstrated that very preterm infants with neonatal sepsis were at higher risk of impairments, such as cerebral palsy and neurosensory deficits, compared with infants without sepsis (OR 3.18; 95% CI 2.29–4.41). Substantial heterogeneity existed across the studies (I2 = 83.1, 95% CI 73–89). The five studies that reported outcomes as continuous variables showed no significant difference in cognitive performance between sepsis and non-sepsis groups. Neonatal sepsis in very preterm infants is associated with increased risk of neurodevelopmental disability. Due to the paucity of longitudinal follow-up data beyond 36 months, the long-term cognitive effect of neonatal sepsis in very preterm infants could not be conclusively determined. Effects on the development of minor impairment could not be assessed, due to the small numbers of infants included in the studies.


Author(s):  
Eduardo Villamor-Martínez ◽  
Maria Pierro ◽  
Giacomo Cavallaro ◽  
Fabio Mosca ◽  
Boris W. Kramer ◽  
...  

Bronchopulmonary dysplasia (BPD) is the most common complication after preterm birth. Pasteurized donor human milk (DHM) has increasingly become the standard of care for very preterm infants over the use of preterm formula (PF) if mother&rsquo;s own milk (MOM) is unavailable. Studies have reported beneficial effects of DHM on BPD. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies on the effects of DHM on BPD and other respiratory outcomes. Eighteen studies met the inclusion criteria. Meta-analysis of RCT&rsquo;s could not demonstrate that supplementation of MOM with DHM reduced BPD when compared to PF (3 studies, risk ratio [RR] 0.89, 95% confidence interval [CI] 0.60&ndash;1.32). However, meta-analysis of observational studies showed that DHM supplementation reduced BPD (8 studies, RR 0.78, 95% CI 0.67&ndash;0.90). An exclusive human milk diet reduced the risk of BPD, compared to a diet with PF and/or bovine milk-based fortifier (3 studies, RR 0.80, 95% CI 0.68&ndash;0.95). Feeding raw MOM, compared to feeding pasteurized MOM, protected against BPD (2 studies, RR 0.77, 95% CI 0.62&ndash;0.96). In conclusion, our data suggest that DHM protects against BPD in very preterm infants, but pasteurization of human milk reduces the benefit.


BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e028066 ◽  
Author(s):  
Souvik Mitra ◽  
Timothy Disher ◽  
Gerhard Pichler ◽  
Brandon D'Souza ◽  
Helen Mccord ◽  
...  

IntroductionAs gestational age decreases, incidence of bronchopulmonary dysplasia (BPD) and chronic lung disease increases. There are many interventions used in the delivery room to prevent acute lung injury and consequently BPD in these patients. The availability of different treatment options often poses a practical challenge to the practicing neonatologist when it comes to making an evidence-based choice as the multitude of pairwise systematic reviews including Cochrane reviews that are currently available only provide a narrow perspective through head-to-head comparisons.Methods and analysisWe will conduct a systematic review of all randomised controlled trials evaluating delivery room interventions within the first golden hour after birth for prevention of BPD. The primary outcome includes BPD. Secondary outcomes include death at 36 weeks of postmenstrual age or before discharge; severe intraventricular haemorrhage (grade 3 or 4 based on the Papile criteria); any air leak syndromes (including pneumothorax or pulmonary interstitial emphysema); retinopathy of prematurity (any stage) and neurodevelopmental impairment at 18–24 months. We will search from their inception to August 2018, the following databases: Medline, EMBASE and Cochrane Central Register of Controlled Trials as well as grey literature resources. Two reviewers will independently screen titles and abstracts, review full texts, extract information and assess the risk of bias and the confidence in the estimate (with Grading of Recommendations Assessment, Development and Evaluation approach). This review will use Bayesian network meta-analysis approach which allows the comparison of the multiple delivery room interventions for prevention of BPD. We will perform a Bayesian network meta-analysis to combine the pooled direct and indirect treatment effect estimates for each outcome, effectiveness and safety of delivery room interventions for prevention of BPD.Ethics and disseminationThe proposed protocol is a network meta-analysis, which has been registered on PROSPERO International prospective register of systematic reviews (CRD42018078648). The results will provide an evidence-based guide to choosing the right sequence of early postnatal interventions that will be associated with the least likelihood of inducing lung injury and BPD in preterm infants. Furthermore, we will identify knowledge gaps and will encourage further research for other therapeutic options. Therefore, its results will be disseminated through peer-reviewed publications and conference presentations. Due to the nature of the design, no ethics approval is necessary.


BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e039366
Author(s):  
Luda Feng ◽  
Ning Liang ◽  
Tingting Li ◽  
Qinyu Yang ◽  
Ping Jiang ◽  
...  

IntroductionIntracerebral haemorrhage (ICH) is a life-threatening condition with no effective internal treatment options. However, edaravone is a promising therapeutic agent, although its beneficial effects are inconclusive based on previous systematic reviews and meta-analyses. While several trials in the last 8 years have reported the favourable long-term functional outcomes, a few reports indicated edaravone to be associated with an increase in adverse events.Methods and analysisThis protocol was performed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. We will perform the comprehensive and manual search for published articles, ongoing trials, dissertations and grey literature. The following databases will be searched from inception to 23 April 2020: Medline, Embase, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese scientific periodical database of VIP INFORMATION, Wanfang Data and SinoMed, with no language restrictions. All randomised controlled trials that (1) compared edaravone with placebo or no treatment, and (2) compared edaravone plus routine treatment or cointervention with routine treatment or cointervention for treating acute ICH will be included. Mortality and long-term dependency will be the primary outcomes. The incidence of adverse events will be assessed for safety evaluation. Two reviewers in pairs will independently carry out the article selection, data extraction and quality assessment. Assessment of the risk of bias and data synthesis will be performed using software Review Manager V.5.3. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the quality of the overall evidence.Ethics and disseminationThere are no ethical considerations associated with this updated systematic review and meta-analysis. The findings will be disseminated in peer-reviewed journals or conference presentations.PROSPERO registration numberCRD42019147801.


BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035513
Author(s):  
Dawn Shu Hui Looi ◽  
Mark Sen Liang Goh ◽  
Sharon Si Min Goh ◽  
Jia Ling Goh ◽  
Rehena Sultana ◽  
...  

IntroductionChildren who suffer from traumatic brain injury (TBI) are at risk of permanent brain damage and developmental deficits. Reports on neurodevelopmental outcomes in paediatric TBI suffer from small sample size and varying outcome definitions in the neurocognitive domains tested. This protocol describes a systematic review and meta-analysis of paediatric TBI in the following key neurocognitive domains: executive function, perceptual–motor function, language, learning and memory, social cognition and complex attention.MethodsA comprehensive search comprising studies from Medline, Cochrane, Embase and PsycINFO published from 1988 to 2019 will be conducted. We will include studies on children ≤18 years old who suffer from mild, moderate and severe TBI as determined by the Glasgow Coma Scale that report neurocognitive outcomes in domains predetermined by the Diagnostic and Statistical Manual of Mental Disorders fifth edition criteria. Systematic reviews, meta-analyses, randomised controlled trials, case–control, cohort and cross-sectional studies will be included. References from systematic reviews and meta-analyses will be hand-searched for relevant articles. A meta-analysis will be performed and effect sizes will be calculated to summarise the magnitude of change in each neurocognitive domain compared at different timepoints and stratified by severity of TBI. Included studies will be pooled using pooled standardised mean differences with a random effects model to determine an overall effect. In the scenario that we are unable to pool the studies, we will perform a narrative analysis.Ethics and disseminationEthics approval is not required for this study.The authors of this study will publish and present the findings in a peer-reviewed journal as well as national and international conferences. The results of this study will provide understanding into the association between different severities of paediatric TBI and long-term neurocognitive outcomes.PROSPERO registration numberCRD42020152680.


BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e045729
Author(s):  
Jhangir Humayun ◽  
Chatarina Löfqvist ◽  
David Ley ◽  
Ann Hellström ◽  
Hanna Gyllensten

ObjectivesTo determine the costs directly or indirectly related to bronchopulmonary dysplasia (BPD) in preterm infants. The secondary objective was to stratify the costs based on gestational age and/or birth weight.DesignSystematic literature review.SettingPubMed and Scopus were searched on 3 February 2020. Studies were selected based on eligibility criteria by two independent reviewers. Included studies were further searched to identify eligible references and citations.Two independent reviewers extracted data with a prespecified data extraction sheet, including items from a published checklist for quality assessment. The costs in the included studies are reported descriptively.Primary outcome measureCosts of BPD.ResultsThe 13 included studies reported the total costs or marginal costs of BPD. Most studies reported costs during birth hospitalisation (cost range: Int$21 392–Int$1 094 509 per child, equivalent to €19 103–€977 397, in 2019) and/or during the first year of life. One study reported costs during the first 2 years; two other studies reported costs later, during the preschool period and one study included a long-term follow-up. The highest mean costs were associated with infants born at extremely low gestational ages. The quality assessment indicated a low risk of bias in the reported findings of included studies.ConclusionsThis study was the first systematic review of costs associated with BPD. We confirmed previous reports of high costs and described the long-term follow-up necessary for preterm infants with BPD, particularly infants of very low gestational age. Moreover, we identified a need for studies that estimate costs outside hospitals and after the first year of life.PROSPERO registration numberCRD42020173234.


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