Dataset Information

Effects of immunotherapy on mortality in neonates with suspected or proven sepsis: a systematic review and network meta-analysis.

ABSTRACT:

Background

To investigate the efficacies of different immunotherapies in neonates with suspected or proven sepsis.

Methods

We searched the Cochrane Library, EMBASE, MEDLINE, EBSCOhost, and Web of Science for studies published before May 2019 that investigated different immunotherapies in neonates with suspected or proven sepsis. Comparisons were among immunotherapies and between immunotherapy and placebo. The review was registered in the PROSPERO CRD database.

Results

All-cause mortality was not significantly different between patients who received the immunoglobulin (IgG), IgM-enriched immunoglobulin (IgGAM), granulocyte-colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) immunotherapies and those who received placebo. The RRs of the immunotherapies were 0.80 (95% CI: 0.57 to 1.1), 0.45 (95% CI: 0.17 to 1.0), 0.93 (95% CI: 0.64 to 1.2) and 0.67 (95% CI: 0.39 to 1.1), respectively. Compared with placebo, none of the interventions showed statistically significant differences in the duration of hospital stay. The MDs of the immunotherapies were?-?2.7 (95% CI: -?8.4 to 3.5), -?0.18 (95% CI: -?7.3 to 7.7), -?1.7 (95% CI: -?7.3 to 3.9) and?-?7.2 (95% CI: -?28 to 13), respectively.

Conclusions

No significant differences in all-cause mortality or the duration of hospital stay were found in neonates with suspected or proven sepsis treated with the four types of immunotherapies and those treated with placebo.

SUBMITTER: Li Y

PROVIDER: S-EPMC6681492 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

Effects of immunotherapy on mortality in neonates with suspected or proven sepsis: a systematic review and network meta-analysis.

Li Yuhang Y Yang Shulong S Wang Guiyue G Liu Miao M Zhang Zhaodi Z Liu Haitao H Yu Kaijiang K Wang Changsong C

BMC pediatrics 20190805 1

<h4>Background</h4>To investigate the efficacies of different immunotherapies in neonates with suspected or proven sepsis.<h4>Methods</h4>We searched the Cochrane Library, EMBASE, MEDLINE, EBSCOhost, and Web of Science for studies published before May 2019 that investigated different immunotherapies in neonates with suspected or proven sepsis. Comparisons were among immunotherapies and between immunotherapy and placebo. The review was registered in the PROSPERO CRD database.<h4>Results</h4>All-c ...[more]

PMID: 31383021

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Project description:BackgroundLate onset sepsis is a leading cause of death and morbidity in preterm infants. Despite optimal antibiotic treatment, sepsis related mortality and morbidity is still high. Pentoxifylline (PTX) is a methylxanthine with promising immunomodulatory properties, which can be used as an additional therapy next to antibiotics in preterm infants. PTX is increasingly used off-label in neonatal intensive care units, however up till now no dose finding study has been done for PTX in this specific population. The aim of this study (PTX-trial) is to determine the optimal dose of PTX in preterm infants (gestational age < 30 weeks) with (suspected) late onset sepsis. Dose finding in this particular population is unique, since for most drugs used in neonates the optimal dosage has not been investigated in phase II dose-seeking studies.MethodsThe PTX-trial is a prospective open label sequential dose-optimization study with an adapted continual reassessment method. An up-and-down dose-response design will be used, with dose step-up and step-down titration after every 3 patients. The PTX starting dosage will be 30 mg/kg/day in 6 hours as described in most previous neonatal studies. Efficacy is defined by means of biochemical and clinical parameters. Toxicity in these vulnerable patients is unwarranted. The optimal dose is defined as the ED75 (i.e., clinically and chemically effective dose for 75% of patients) in preterm neonates with late onset sepsis. We plan to include 30 neonates to determine the optimal dose using this study design. Subsequently, the optimal dose will be validated in 10 additional preterm neonates. In parallel, pharmacokinetics of PTX and its metabolites will be described as well as longitudinal evaluation of metabolomics and proteomics.DiscussionThe study has been approved by the Regional Medical Ethics Board of Erasmus Medical Center University Rotterdam (MEC 2019-0477) and registered at Clinicaltrials.gov (NCT04152980). Results of the main trial and each of the secondary endpoints will be submitted for publications in peer-reviewed journals.Trial registrationClinicaltrials.gov, NCT04152980 , Registered November 6th, 2019.

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Dataset Information

Effects of immunotherapy on mortality in neonates with suspected or proven sepsis: a systematic review and network meta-analysis.

Background

Methods

Results

Conclusions

Publications

Effects of immunotherapy on mortality in neonates with suspected or proven sepsis: a systematic review and network meta-analysis.

Similar Datasets

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