Reducing the prescription of antibiotics in newborn infants suspected for having an early onset sepsis.

Reducing the prescription of antibiotics in newborn infants suspected for having an early onset sepsis. - Reducing Antibiotic Prescription / RAP

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON31252

Enrollment

920

Registered

2007-10-12

Start date

2008-01-03

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Early Onset Sepsis Infection

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1.) A newborn infant who is admitted to a pediatric or to a maternity ward and in whom an EOS cannot be excluded.;2.) A newborn infant who is admitted to a pediatric ward for glucose controls and who is not suspected for an EOS.

Exclusion criteria

Exclusion criteria: 1a.) Newborn infant older than 6 hours.;2a.) Newborn infant older than 6 hours. 2b.) Newborn infant suspected for an EOS.

Design outcomes

Primary

Measure	Time frame
Primary outcome: proven EOS Primary parameters: cytokine levels direct post partum (umbilical cord and infant), 4 hours post partum, 24 hours post partum and 48 hours post partum.	—

Secondary

Measure	Time frame
Secundary outcome: 1.) Proven EOS, 2.) Clinical EOS, 3.) Suspected EOS but afterwards no EOS and 4.) No EOS and never suspected for an EOS. Secundary parameters: CRP Gestational age Birth weight Gender Number of previous pregnancies Parity Route of delivery Antibiotic usage mother ante partum Corticosteroid usage mother Duration of rupture of membranes Body temperature mother Temperature delivery room Epidural anesthesia mother CTG Umbilical cord pH Meconium aspiration Amnionitis Intracranial bleeding Respiratory problems Circulatory problems Neurological problems Gastro-intestinal problems Pathogen of Early Onset Sepsis Antibiotic prescription infants (duration & type) Outcome	—

Measure

Time frame

Secundary outcome: 1.) Proven EOS, 2.) Clinical EOS, 3.) Suspected EOS but afterwards no EOS and 4.) No EOS and never suspected for an EOS. Secundary parameters: CRP Gestational age Birth weight Gender Number of previous pregnancies Parity Route of delivery Antibiotic usage mother ante partum Corticosteroid usage mother Duration of rupture of membranes Body temperature mother Temperature delivery room Epidural anesthesia mother CTG Umbilical cord pH Meconium aspiration Amnionitis Intracranial bleeding Respiratory problems Circulatory problems Neurological problems Gastro-intestinal problems Pathogen of Early Onset Sepsis Antibiotic prescription infants (duration & type) Outcome

—

Countries

Netherlands

Outcome results