Immunogenetic, pharmacological and neurodevelopmental aspects of nosocomial sepsis and meningitis in preterm infants.

Immunogenetic, pharmacological and neurodevelopmental aspects of nosocomial sepsis and meningitis in preterm infants. - Preterms with sepsis: immunology, treatment and long term sequelae.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39135

Enrollment

280

Registered

2008-07-09

Start date

2009-03-01

Completion date

Unknown

Last updated

2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

blood stream infection sepsis

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1. written and informed consent from both parents or legal guardian. 2. gestational age

Exclusion criteria

Exclusion criteria: 1. syndromal or chromosomal abnormalities. 2. congenital metabolic disease.

Design outcomes

Primary

Measure	Time frame
1. Association of RT-PCR compared to culture (blood, CSF) with relation to bacterial detection (time till result, at which bacterial load does the culture become positive) 2. Immune response of the infant in relation to bacterial type and load in blood and CSF 3. Immune response of the infant in relation to specific polymorphisms 4. Association between plasma antibiotic concentrations and pharmacodynamic effects (clinical improvement, decrease in C-reactive protein, decrease in bacterial load in blood and/or CSF) 5. Study of specific co-variates (including polymorphisms) which influence pharmacokinetics and pharmacodynamics Main study parameters/endpoints: 1. Cerebral perfusion patterns in preterm infants during (suspected) nosocomial sepsis/ meningitis (during 72 hours). 2. aEEG background patterns and presence of seizure activity in preterms during (suspected) sepsis/ meningitis (during 72 hours). 3. Development of white matter injury or cerebral hemorrhage following a confirmed bloodstream infection, related to microorganism (confirmed by bloodculture or PCR) and/or cytokine response. 4. Neuropsychodevelopmental outcome at two years of life (corrected for prematurity).	—

Measure

Time frame

1. Association of RT-PCR compared to culture (blood, CSF) with relation to bacterial detection (time till result, at which bacterial load does the culture become positive) 2. Immune response of the infant in relation to bacterial type and load in blood and CSF 3. Immune response of the infant in relation to specific polymorphisms 4. Association between plasma antibiotic concentrations and pharmacodynamic effects (clinical improvement, decrease in C-reactive protein, decrease in bacterial load in blood and/or CSF) 5. Study of specific co-variates (including polymorphisms) which influence pharmacokinetics and pharmacodynamics Main study parameters/endpoints: 1. Cerebral perfusion patterns in preterm infants during (suspected) nosocomial sepsis/ meningitis (during 72 hours). 2. aEEG background patterns and presence of seizure activity in preterms during (suspected) sepsis/ meningitis (during 72 hours). 3. Development of white matter injury or cerebral hemorrhage following a confirmed bloodstream infection, related to microorganism (confirmed by bloodculture or PCR) and/or cytokine response. 4. Neuropsychodevelopmental outcome at two years of life (corrected for prematurity).

—

Secondary

Measure	Time frame
Neuropsychological development during the first 2 years, and growth and body composition of infants who suffered a neonatal sepsis or meningitis	—

Countries

Netherlands

Outcome results