[Disparity in the criteria for including patients with neonatal sepsis in scientific medical studies. Are we swimming in a sea without limits?].
OBJECTIVE
To characterize disparity in the criteria used for patient enrollment in clinical research on neonatal sepsis.


METHODS
We used MEDLINE to identify clinical research in neonatal sepsis published in English from 1993 to 2005. We used the criteria of the International Consensus Conference Panel: International Pediatric Sepsis Consensus Conference: Definitions for Sepsis and Organ Dysfunction in Pediatrics (IPSCC) published in 2005 as an arbitrary standard in each of the articles. Articles were considered to define neonatal sepsis clearly if they mentioned the criteria and described the values used. Articles were considered not to define neonatal sepsis clearly if they used the phrase "septic patients were included" without describing the variables or values used for inclusion.


RESULTS
We identified 150 articles, of which 26.6 % specified the criteria and values of the IPSCC. The remaining 110 articles did not mention the values or the variables used to define neonatal sepsis.


CONCLUSIONS
There is a disparity in the criteria used to operatively define neonatal sepsis in clinical studies performed in distinct parts of the world.
Reyna-Figueroa
J
J
Departamento de Infectología e Inmunología Perinatal, Instituto Nacional de Perinatología Isidro Espinosa de los Reyes, Secretaría de Salud, México.
Yuri-Toala
E
E
Ortiz-Ibarra
F J
FJ
Rodríguez-Ramírez
E
E
Limón-Rojas
A E
AE
D035843:Biomedical Research / Q000592:standards*; D006801:Humans; D007231:Infant, Newborn; D018579:Patient Selection; D010506:Periodicals as Topic; D018805:Sepsis; D009626:Terminology as Topic