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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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31 October 2016 |
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Main ID: |
NCT02486783 |
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Date of registration:
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27/06/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Infection, Sepsis and Meningitis in Surinamese Neonates
InSepSur |
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Scientific title:
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Infection, Sepsis and Meningitis in Surinamese Neonates |
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Date of first enrolment:
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May 2015 |
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Target sample size:
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190 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02486783 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Suriname
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Contacts
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Name:
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Grietje Molema, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Center Groningen, The Netherlands |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
This study aims to include all neonates presenting here and at the high and medium care
facilities with clinical signs of infection, sepsis or meningitis (age: 0-1 month) that
require infection work up (i.e., laboratory testing and culturing):
- Baseline controls: uncomplicated jaunice, no other signs of infection
- Clinical signs of infection: tachypnea, dyspnea, apnea, grunting, tachycardia,
bradycardia, hypotension, poor perfusion, vomitus, abdominal distension,
constipation, poor feeding, lethargy, irritability, convulsions, temperature
instability, pale, yellow, bleak, petechiae, bruising, bleeding.
Exclusion Criteria:
- Extreme prematurity: gestational below 32 weeks of gestational age
- Extreme dysmaturity: birthweight below 1500 grams
- Maternal HIV or malignancy
Age minimum:
N/A
Age maximum:
1 Month
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neonatal Infection
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Neonatal Meningitis
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Neonatal Sepsis
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Primary Outcome(s)
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Presence of infection upon signs of infection
[Time Frame: Within 7 days]
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Secondary Outcome(s)
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Overall mortality due to infection
[Time Frame: 1 year]
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Infection related mortality
[Time Frame: 7 day and 30 day]
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Secondary ID(s)
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VG 021-14A
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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