An observational study in Infant Newborn Disease, sponsored by Instituto Tecnologico y de Estudios Superiores de Monterey. Completed at 1 site in Mexico. Open to participants aged 1 Day to 180 Days. Per ClinicalTrials.gov, last updated 2023-03-01.
Sponsored by Instituto Tecnologico y de Estudios Superiores de Monterey · Observational
The main objective of this project is to establish a prospective cohort to measure the Gram-negative infection burden in neonates under special care in a regional referral hospital, and to characterize all microorganisms isolates from these subjects at the phenotype and genotype level, specifically in relation to the expression of multi-drug resistance (MDR) associated genes (Molecular characterization of Gram-negative MDR isolates).
The investigators propose a mixed design approach, a cohort´s study with a nested case-control analysis. Study subjects will be the gram-negative isolates at the study hospital clinical laboratory. The cohort´s exposure factor will be the presence or absence of a multidrug resistance gram-negative bacterial isolate.
The prospective cohort will allow the estimation of Gram-negative infection burden in the study population, and the characterization of all microorganisms isolates from study subjects at the phenotype and genotype level, specifically in relation to the expression of multi-drug resistance (MDR) associated genes (Molecular characterization of Gram-negative MDR isolates); the cohort will be formed by each neonate, from the admission to special care, the isolation date and then follow-up until the resolution, being it discharge either alive, dead or by transfer to another facility. Risk ratios for each of these outcomes will be calculated.
Cases-controls analysis will allow the research team to identify main risk factors present in those individuals who further had or did not have a gram-negative MDR isolate, by calculation of associated odds ratios for concurrent perinatal factors. Another project goal, to establish correlations and measure risk factors (Odds ratios) between Gram-negative infection with MDR organisms and concurrent illness and treatments offered in the special care nursery (medical [antibiotics, non-steroid anti-inflammatory drugs, steroids, others], surgical, and clinical procedures) in neonates under special care, will also be attained through the nested cases and controls study approach.
Finally, a derivative from this project will be the establishment of the North-East Mexico Regional Repository of bacterial isolates in Neonates under special care. At the first stage, this repository will preserve specimens of bacteria, both Gram-negative and Gram-positive, along with a specially developed anonymous database of the individuals hosting those infections. In the near future, the focus of this repository may expand to fungus, parasites and perhaps viral isolates preservation.
The research team has also proposed an exploratory objective, subject to budget availability, and that is the characterization and comparison of the immuno-phenotype of those individuals affected of Gram-negative infection with MDR resistant organisms, those with infection with other organisms and those not affected by infectious complications.
All gram-negative isolates will be probed for the gene expression of 38 selected antibiotic resistance loci, and 96 selected samples will be further studied by next generation sequentiation.
Instituto Tecnologico y de Estudios Superiores de Monterey is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Neonates, both at term and preterm, of any gestational age, under special care in the Neonatology Division of a tertiary care regional perinatal center in the Northeast of Mexico.
Exclusion Criteria:
Neonates with one or more gram-negative bacterial isolates with MDR characteristics during their clinical course in the Neonatal Intensive Care Unit of the study hospital.
Diagnostic Test: Identification of MDR characteristics
Neonates with one or more gram-negative bacterial isolates with no MDR characteristics during their clinical course in the Neonatal Intensive Care Unit of the study hospital.
Diagnostic Test: Identification of MDR characteristics
Identification of MDR in culture media, followed by amplification of related genes from the bacterial isolates
Burden of Gram Negative organisms infections
The isolation of a gram-negative organism, from any clinical site, in neonates under clinical care in special care nursery; Incidence = New cases during the study period, Prevalence = Total cases during the study period.
Time frame: Through study completion, an average of three months
Odds ratio for the occurrence of Gram-negative MDR infections
To identify and measure the Odds-ratio for the occurrence of Gram-negative infection with MDR resistant organisms and all concurrent perinatal factors. This will be done through a nested case and controls study approach.
Time frame: Through study completion, an average of three months
Risk factors for the occurrence of Gram-negative MDR infections.
To establish correlations and measure risk factors (Relative risks) between Gram-negative infection with MDR organisms and concurrent illness and treatments offered in the special care nursery (medical \[antibiotics, non-steroid anti-inflammatory drugs, steroids, others\], surgical, and clinical procedures) in neonates under special care. This will be attained with a cohorts study approach.
Time frame: Through study completion, an average of three months
Plan to share: Undecided — Initially, we plan to share raw data with qualified researchers and entities worldwide, but we have not yet decided a specific repository.
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Instituto Tecnologico y de Estudios Superiores de Monterey