Dataset Information

Does surfactant nebulization prevent early intubation in preterm infants? A protocol for a systematic review and meta-analysis.

ABSTRACT:

Background

Respiratory distress syndrome (RDS) is the most common cause of respiratory failure in preterm infants. Treatment consists of respiratory support and exogenous surfactant administration. Commonly, surfactant is administered intratracheally. However, this requires airway instrumentation and subsequent fluid instillation which may be harmful. Surfactant nebulization (SN) may offer a safe and effective alternative for surfactant administration, but the clinical efficacy is not yet established. Thus, this systematic review and meta-analysis of randomized controlled trials will summarize the available evidence to determine the effectiveness and safety of SN for the prevention of intubation and subsequent mechanical ventilation at 72?h after birth.

Methods

A systematic literature search in Medline, Embase, and The Cochrane Library will be performed, and all randomized controlled trials (RCTs) and quasi-RCTs from published articles, presentations, and trial registries will be included in this meta-analysis. Titles and abstracts of all records identified in the search will be screened by two reviewers independently. Data on preterm infants (? 37?weeks) receiving nebulized surfactant in the first 72?h after birth for the treatment or prevention of RDS will be evaluated. Primary outcome is the intubation rate by 72?h after birth, and secondary outcomes include peridosing safety effects as well as major neonatal morbidities. Risk of bias will be assessed using the revised Cochrane ROB tool, and subgroup analyses will be performed to evaluate potential confounding factors. Publication bias will be assessed by examining a funnel plot. The meta-analysis will be performed using a fixed-effects model.

Discussion

This review will provide an evidence-based tool for information about surfactant nebulization, illustrating the current knowledge and hopefully revealing potential novel avenues for researchers and clinicians alike.

Systematic review registration

This review is registered with the publicly available resource PROSPERO ( CRD42020175625 ).

SUBMITTER: Gaertner VD

PROVIDER: S-EPMC7786931 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature

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Publications

Does surfactant nebulization prevent early intubation in preterm infants? A protocol for a systematic review and meta-analysis.

Gaertner Vincent D VD Bassler Dirk D Rüegger Christoph M CM

Systematic reviews 20210106 1

<h4>Background</h4>Respiratory distress syndrome (RDS) is the most common cause of respiratory failure in preterm infants. Treatment consists of respiratory support and exogenous surfactant administration. Commonly, surfactant is administered intratracheally. However, this requires airway instrumentation and subsequent fluid instillation which may be harmful. Surfactant nebulization (SN) may offer a safe and effective alternative for surfactant administration, but the clinical efficacy is not ye ...[more]

PMID: 33407775

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Project description:BACKGROUND:There are limited data to inform the choice between early treatment with continuous positive airway pressure (CPAP) and early surfactant treatment as the initial support for extremely-low-birth-weight infants. METHODS:We performed a randomized, multicenter trial, with a 2-by-2 factorial design, involving infants who were born between 24 weeks 0 days and 27 weeks 6 days of gestation. Infants were randomly assigned to intubation and surfactant treatment (within 1 hour after birth) or to CPAP treatment initiated in the delivery room, with subsequent use of a protocol-driven limited ventilation strategy. Infants were also randomly assigned to one of two target ranges of oxygen saturation. The primary outcome was death or bronchopulmonary dysplasia as defined by the requirement for supplemental oxygen at 36 weeks (with an attempt at withdrawal of supplemental oxygen in neonates who were receiving less than 30% oxygen). RESULTS:A total of 1316 infants were enrolled in the study. The rates of the primary outcome did not differ significantly between the CPAP group and the surfactant group (47.8% and 51.0%, respectively; relative risk with CPAP, 0.95; 95% confidence interval [CI], 0.85 to 1.05) after adjustment for gestational age, center, and familial clustering. The results were similar when bronchopulmonary dysplasia was defined according to the need for any supplemental oxygen at 36 weeks (rates of primary outcome, 48.7% and 54.1%, respectively; relative risk with CPAP, 0.91; 95% CI, 0.83 to 1.01). Infants who received CPAP treatment, as compared with infants who received surfactant treatment, less frequently required intubation or postnatal corticosteroids for bronchopulmonary dysplasia (P<0.001), required fewer days of mechanical ventilation (P=0.03), and were more likely to be alive and free from the need for mechanical ventilation by day 7 (P=0.01). The rates of other adverse neonatal outcomes did not differ significantly between the two groups. CONCLUSIONS:The results of this study support consideration of CPAP as an alternative to intubation and surfactant in preterm infants. (ClinicalTrials.gov number, NCT00233324.)

Project description: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.

Project description:ObjectivePrevious some systematic reviews reported that probiotics may benefit the prevention of NEC in preterm infants. But dissimilar bacterial strains and taxa used in included studies possibly result in bias. There is not a rounded systematic review which has estimated the benefit and safety of Enterococcus faecium to prevent NEC in preterm infants to date before we conducted.MethodsThis systematic review of randomized controlled trials and retrospective studies analyzing the benefit of Enterococcus faecium to prevent NEC in preterm infants was performed using PubMed, Web of Science, Cochrane Library, EMBASE, Wanfang data and China National Knowledge Infrastructure databases from inception to April 14, 2023. The search terms were "preterm" AND "necrotizing enterocolitis" AND "Enterococcus faecium OR probiotics." Studies reporting NEC involving preterm infants who were given Enterococcus faecium were included in this systematic review. A sensitivity analysis was conducted to assess the stability of results. A funnel plot was generated to identify publication bias. Two authors appraised studies quality and extracted data independently. This work has been reported according with preferred reporting items for systematic reviews and meta-analyses and assessing the methodological quality of systematic reviews. Statistical analysis was conducted using Review Manager 5.3 software. Risk ratio (RR) with 95% confidence intervals (CI) was calculated and analyzed.ResultsSeven studies (N = 1487 participants) were included in this systematic review, and 6 randomized, controlled trials (N = 1237 participants) were included in the meta-analysis. Comparing with the control groups, the Enterococcus faecium groups had a significant decline in the incidence of NEC Bell stage II or higher (RR: 0.3138, 95% CI: 0.1983-0.4965; P < .00001; 6 studies, n = 1237) and infection (RR: 0.4818, 95% CI: 0.2950-0.7869; P = .004; 3 studies, n = 710).ConclusionsEnterococcus faecium is effective and safe in preventing NEC (Bell stage II or higher) in preterm infants. But all studies included came from China. The dosages and durations of taking Enterococcus faecium were various.

Project description:BackgroundThe ideal threshold at which surfactant administration in preterm neonates with respiratory distress syndrome (RDS) is most beneficial is contentious. The aim of this systematic review was to determine the optimal clinical criteria to guide surfactant administration in preterm neonates with RDS.MethodsThe systematic review was registered in PROSPERO (CRD42022309433). Medline, Embase, CENTRAL and CINAHL were searched from inception till 16th May 2023. Only randomized controlled trials (RCTs) were included. A Bayesian random effects network meta-analysis (NMA) evaluating 33 interventions was performed. The primary outcome was requirement of invasive mechanical ventilation (IMV) within 7 days of life.Findings58 RCTs were included. In preterm neonates ≤30 weeks after adjusting for the confounding factor of modality of surfactant administration, an arterial alveolar oxygen tension ratio (aAO2) <0.36 (FiO2: 37-55%) was ranked the best threshold for decreasing the risk of IMV, very low certainty. Further, surfactant administration at an FiO2 40-45% possibly decreased mortality compared to rescue treatment when respiratory failure was diagnosed, certainty very low. The reasonable inference that could be drawn from these findings is that surfactant administration may be considered in preterm neonates of ≤30 weeks' with RDS requiring an FiO2 ≥ 40%. There was insufficient evidence for the comparison of FiO2 thresholds: 30% vs. 40%. The evidence was sparse for surfactant administration guided by lung ultrasound. For the sub-group >30 weeks, nebulized surfactant administration at an FiO2 < 30% possibly increased the risk of IMV compared to Intubate-Surfactant-Extubate at FiO2 < 30% and 40%, and less invasive surfactant administration at FiO2 40%, certainty very low.InterpretationSurfactant administration may be considered in preterm neonates of ≤30 weeks' with RDS if the FiO2 requirement is ≥40%. Future trials are required comparing lower FiO2 thresholds of 30% vs. 40% and that guided by lung ultrasound.FundingNone.

Project description:IntroductionMany preterm infants develop respiratory distress syndrome (RDS), a condition characterised by a relative lack of surfactant. Endotracheal surfactant therapy revolutionised the care of preterm infants in the 1990s. However, supporting newborns with RDS with continuous positive airway pressure (CPAP) and reserving endotracheal surfactant for those who develop respiratory failure despite CPAP yield better results than intubating all infants for surfactant. Half of preterm infants born before 29 weeks gestation initially managed with CPAP are intubated for surfactant. Intubation is difficult to learn and associated with adverse effects. Surfactant administration into the oropharynx has been reported in preterm animals and humans and may be effective. We wished to determine whether giving oropharyngeal surfactant at birth reduces the rate of endotracheal intubation for respiratory failure in preterm infants within 120 hours of birth.Methods and analysisProphylactic Oropharyngeal surfactant for Preterm infants: A Randomised Trial (POPART, Eudract No. 2016-004198-41) is an investigator-led, unblinded, multicentre, randomised, parallel group, controlled trial. Infants are eligible if born at a participating centre before 29 weeks gestational age (GA) and there is a plan to offer intensive care. Infants are excluded if they have major congenital anomalies. Infants are randomised at birth to treatment with oropharyngeal surfactant (120 mg vial <26 weeks GA stratum; 240 mg vial 26-28+6 weeks GA stratum) in addition to CPAP or CPAP alone. The primary outcome is intubation within 120 hours of birth, for bradycardia and/or apnoea despite respiratory support in the delivery room or respiratory failure in the intensive care unit. Secondary outcomes include incidence of mechanical ventilation, endotracheal surfactant use, chronic lung disease and death before hospital discharge.Ethics and disseminationApproval for the study has been granted by the Research Ethics Committees at the National Maternity Hospital, Dublin, Ireland (EC31.2016) and at each participating site. The trial is being conducted at nine centres in six European countries. The study results will be submitted for publication in a peer-reviewed journal.Trial registration number2016-004198-41; Pre-results.

Project description:BackgroundAs preterm infants' neurodevelopment is shaped by NICU-related factors during their hospitalization, it is essential to evaluate which interventions are more beneficial for their neurodevelopment at this specific time. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of interventions initiated during NICU hospitalization on preterm infants' early neurodevelopment during their hospitalization and up to two weeks corrected age (CA).MethodsThis systematic review referred to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] guidelines and was registered in PROSPERO (CRD42017047072). We searched CINAHL, MEDLINE, PubMed, EMBASE (OVID), Cochrane Systematic Reviews, CENTRAL, and Web of Science from 2002 to February 2020 and included randomized controlled/clinical trials conducted with preterm infants born between 24 and 366/7 weeks of gestation. All types of interventions instigated during NICU hospitalization were included. Two independent reviewers performed the study selection, data extraction, assessment of risks of bias and quality of evidence.ResultsFindings of 12 studies involving 901 preterm infants were synthesized. We combined three studies in a meta-analysis showing that compared to standard care, the NIDCAP intervention is effective in improving preterm infants' neurobehavioral and neurological development at two weeks CA. We also combined two other studies in a meta-analysis indicating that parental participation did not significantly improve preterm infants' neurobehavioral development during NICU hospitalization. For all other interventions (i.e., developmental care, sensory stimulation, music and physical therapy), the synthesis of results shows that compared to standard care or other types of comparators, the effectiveness was either controversial or partially effective.ConclusionsThe overall quality of evidence was rated low to very low. Future studies are needed to identify interventions that are the most effective in promoting preterm infants' early neurodevelopment during NICU hospitalization or close to term age. Interventions should be appropriately designed to allow comparison with previous studies and a combination of different instruments could provide a more global assessment of preterm infants' neurodevelopment and thus allow for comparisons across studies.Trial registrationProspero CRD42017047072 .

Dataset Information

Does surfactant nebulization prevent early intubation in preterm infants? A protocol for a systematic review and meta-analysis.

Background

Methods

Discussion

Systematic review registration

Publications

Does surfactant nebulization prevent early intubation in preterm infants? A protocol for a systematic review and meta-analysis.

Similar Datasets

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