NCT00487019

Completed

Management of Early Onset Neonatal Septicaemia: Selection of...

University of Tartu Source

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Other study identifiers

Sponsor study identifier

038FAR042005

Study Type

observational

Actual enrollment (reported)

281

Locations

1 country

Sites

2

Timeline

Study Start

August 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

December 2007

Actual (reported)

Brief Summary

A prospective two-center antibiotic regimen switch study will be conducted to compare the clinical efficacy of two antibiotic regimens - penicillin/gentamicin versus ampicillin/gentamicin - in the empirical treatment of early onset neonatal sepsis. The influence of either regimen on bowel colonization pattern and on the development of antibiotic resistance of gut microflora will also be assessed. The primary endpoint is the need for a change in antibacterial treatment within 72 hours of therapy, based on pre-defined criteria. Secondary endpoints will be the incidence rate and etiology of early and late onset neonatal sepsis and susceptibility pattern of causative microorganisms; mortality rate within 60 days; duration of hospitalization in NICU; duration of artificial ventilation; colonization pattern and susceptibility of colonizing bacteria (including resistance to empiric antibiotic regimen).

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 281 participants
Study completion date: December 2007
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

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Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
August 2006
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
June 14, 2007
Actual (reported)
First Posted
June 15, 2007
Actual (reported)
Study Completion
December 2007
Actual (reported)

Last Updated: May 29, 2008
Status Verified: May 2008
Last Update Submitted: May 27, 2008

Conditions

Early Onset Neonatal Sepsis

Keywords

ampicillinpenicillin Ggentamicinneonatal sepsisempiric therapy

Study Arms (2)

1

Neonates aged \<72 h and needing antibacterial therapy for early onset neonatal sepsis

2

Same as group 1

Eligibility Criteria

AgeUp to 72 Hours

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodProbability Sample

Study Population

Neonates hospitalised within 72h of life and requiring empirical antibacterial treatment for early onset neonatal sepsis.

You may qualify if:

All neonates, admitted to the study NICU-s at the age of less than 72 hours and needing early empiric antibiotic treatment according to pre-defined criteria as described by Schrag et al. (2002)

Sponsors & Collaborators

European Society for Paediatric Infectious Diseases
Othercollaborator
Estonian Science Foundation
Governmentcollaborator

Study Sites (2)

Tallinń's Childrens Hospital, Paediatric Intensive Care Unit

Tallinn, Estonia

Tartu University Clinics, Department of Paediatric Intensive Care

Tartu, 50411, Estonia

Related Publications (1)

Schrag S, Gorwitz R, Fultz-Butts K, Schuchat A. Prevention of perinatal group B streptococcal disease. Revised guidelines from CDC. MMWR Recomm Rep. 2002 Aug 16;51(RR-11):1-22.
PMID: 12211284BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

SepsisInfectionsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Irja Lutsar, MD, PhD
University of Tartu
STUDY CHAIR

Enrollment

281 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER

Study Record Dates

First Submitted

June 14, 2007

First Posted

June 15, 2007

Study Start

August 2006

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Subjects, who on clinical or other indications (e.g. suspected/proven meningitis or abdominal cavity infection, isolation of resistant bacteria from the mother of a neonate with severe sepsis) need antibiotic treatment other than specified in the study protocol and infants who are likely to be transferred to other units within 24 hours.

Contact the study team to confirm eligibility.

University of Tartu

Otherlead

Study Completion

December 2007

Actual (reported)

Last Updated

May 29, 2008

Record last verified: 2008-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00487019
Data provider: ClinicalTrials.gov
Source updated: 2008-05-29
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:26 UTC

Locations

EE(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Study Arms (2)

1

2

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations