Clinical Trial: Infection, Sepsis and Meningitis in Surinamese Neonates

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Infection, Sepsis and Meningitis in Surinamese Neonates

Brief Summary:

Suriname is a small developing country in South America with a population of half a million people. Early neonatal death in Suriname is high with 16 per 1000 live births. Unpublished data from the Suriname Perinatal and Infant Mortality Survey estimate contribution of infection to early neonatal mortality at 25% (4 per 1000 live births) of all deaths. In comparison, incidence rates of neonatal sepsis alone are 3.5 per 1000 live births. These numbers indicate an increased burden of neonatal infection in Suriname versus the U.S. In any case about 40 newborns that die each year of infection are a huge loss, also considering the small Surinamese community. Despite this overall idea on the impact of infectious disease in Surinamese neonates exact information regarding incidence, type of infection (e.g., localized, viral, early-onset or late-onset sepsis), risk factors (e.g., insufficient antenatal care, maternal Group B-Streptococcus status), etiology, microbial causes, morbidity, antibiotic treatment (type and duration), and epidemiological determinants (e.g., gestational age, sex, ethnicity) are lacking.

From a clinical perspective, there is still a challenge to identify neonates with infection. Neonates are often admitted with ambivalent clinical symptoms and receive preventive antibiotics that are costly, promote pathogen-resistance, and have negative long-term effects (i.e., on the development of the intestinal bacterial flora). Currently, assessment of blood leukocyte or trombocyte counts and levels of CRP are insufficiently sensitive to be used as biomarkers, while confirmation of actual sepsis or meningitis by positive culture results is relatively rare (0.5-3% in the United States). This complicates decisions on duration of antibiotic treatment and hospitalization significantly, while no other biomarkers exist.

The cir

Detailed Summary:

Study Design:

The Academic Hospital Paramaribo (AZP) has the largest perinatal care facility in Suriname. Recently, the AZP opened the country's only neonatal intensive care unit (NICU). 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. Along with the inclusion of these neonates follows a detailed epidemiological description of newborns with infectious disease. Inclusion will take place by one of 10 residents, with approval from one of the 5 attending pediatricians. Along with standard blood draws for infection parameters (at t=0 and t=48 hours), blood culture (at t=0 hours) and CSF culture (at t=0 hours), serum and CSF will be separated for our biomarker study. For all neonates, normal local protocol for the management of infection, sepsis or meningitis will be followed. This includes antibiotic treatment for 7 days when 1) clinical suspicion of infection at admission was high; 2) infection parameters are aberrant at 48 hours; 3) blood culture is positive. Otherwise, antibiotic treatment is stopped after 48 hours. Further protocol includes necessary changes in respiratory support, circulatory (fluid) support and feeding. Medical treatments can be cardiotonics and treatments for hyperglycemia and seizures. Neonates are divided over 5 groups based on course of antibiotic treatment and culture results: 1) Baseline controls (no signs of infection): neonates admitted for serial blood draws at t=0 and 48 hours for uncomplicated hyperbilirubinemia (with jaundice, but without other signs of infection); 2) Signs of infection, further divided in: 2a) No infection: antibiotics stopped after 48 hours; negative cultures; 2b) Clinical infection: 7 day antibiotics; negative cultures; 2c) Sepsis: positive bacterial blood culture; 2d) Me
Sponsor: Academic Hospital Paramaribo

Current Primary Outcome: Presence of infection upon signs of infection [ Time Frame: Within 7 days ]

Descision on duration of antibiotics (48 hours or 7 days) and blood and liquor culture results


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Infection related mortality [ Time Frame: 7 day and 30 day ]
  • Overall mortality due to infection [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: Academic Hospital Paramaribo

Dates:
Date Received: June 27, 2015
Date Started: May 2015
Date Completion:
Last Updated: October 20, 2016
Last Verified: October 2016