Ignite Creation Date:
2024-05-05 @ 9:20 PM
Last Modification Date:
2024-10-26 @ 10:02 AM
Study NCT ID:
NCT00861055
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2009-03-12
Brief Title:
Neonatal Sepsis and GBS Carriage Study
Sponsor:
University of Oxford
Organization:
University of Oxford
Study Overview
Official Title:
A Clinical and Microbiological Study of Early Onset Neonatal Sepsis in Refugee Infants and Group B Streptococcal Carriage in Expectant Refugee Mothers Living on the Thai-Burmese Border
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
Recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NSS
Brief Summary:
In the proposed study the investigators plan to establish the burden of early onset EO neonatal sepsis in the newborn population born at Maela Refugee Camp over a two year period
Aims
1 Define the contribution of Group B streptococcusGBS to this problem by establishing
The prevalence of maternal GBS carriage
The prevalence of culture positive and culture negative EO GBS sepsis
The perinatal risk factors for EO GBS cases
2 Through these data assess the potential for intrapartum antibiotic prophylaxis using different strategies for reducing the burden of neonatal sepsis in this setting
3 To define the serotypes and antibiotic susceptibility profile of carried and invasive GBS strains
4 To evaluate the prevalence of serum antibodies to common GBS capsular serotypes in pregnant women in this population the influence of carriage on serotype ST-specific antibody and the ST-specific antibody concentrations in the mothers of cases of confirmed and clinical GBS disease
Aims
1 Define the contribution of Group B streptococcusGBS to this problem by establishing
The prevalence of maternal GBS carriage
The prevalence of culture positive and culture negative EO GBS sepsis
The perinatal risk factors for EO GBS cases
2 Through these data assess the potential for intrapartum antibiotic prophylaxis using different strategies for reducing the burden of neonatal sepsis in this setting
3 To define the serotypes and antibiotic susceptibility profile of carried and invasive GBS strains
4 To evaluate the prevalence of serum antibodies to common GBS capsular serotypes in pregnant women in this population the influence of carriage on serotype ST-specific antibody and the ST-specific antibody concentrations in the mothers of cases of confirmed and clinical GBS disease
Detailed Description:
Globally 4 million neonates die each year the most common cause of death is sepsis Causes of neonatal sepsis in low and middle income countries are reported to differ from those in the developed world Gram negative organisms are thought to be more common Despite group B streptococcus GBS carriage rates being apparently similar to the developed world GBS sepsis is rarely reported in developing countries our hypothesis is that GBS is an under recognized neonatal pathogen in the developing world There are many possible explanations why GBS infection may be under reported including wider less discriminating use of antibiotics in the period just before the onset of labour and inadequate microbiological diagnostic services
The proposed study to be conducted at Maela Refugee Camp Thailand has two components both being prospective descriptive cohort studies which will be run concurrently
1 Contribution of GBS to early onset neonatal sepsis at Maela refugee camp
2 GBS carriage seroepidemiology and GBS antibody study Infants with neonatal sepsis will be identified clinically They will be assessed and after informed consent is taken from their mother they will have a full septic screen including a complete blood count serum C-reactive protein blood culture lumbar puncture and a deep swab taken from their ear canal If the ear swab is positive for GBS and the blood culture is negative for other pathogens a presumptive diagnosis of EO GBS sepsis will be made The mother will have 5ml blood sample for GBS serotype-specific antibody testing and a vaginal rectal swab obtained if this has not been performed already
Women who consent to take part in the GBS carriage study will during labour have a low vaginal and rectal swab taken which will be processed using the CDC Group B streptococcus guideline Additionally a GBS-specific PCR of the swab will be used to identify culture-negative cases of GBS carriage 5ml of venous blood will be taken from the mother and 5ml of blood taken after delivery from the placenta from the umbilical vein for GBS antibody studies
This study will establish the burden of clinical early onset neonatal sepsis in our population Additionally this study will establish the prevalence of maternal GBS carriage and assess the potential for intrapartum antibiotic prophylaxis for reducing the burden of neonatal sepsis in this setting It will also define the serotypes and antibiotic susceptibility profile of carried and invasive GBS strains
The proposed study to be conducted at Maela Refugee Camp Thailand has two components both being prospective descriptive cohort studies which will be run concurrently
1 Contribution of GBS to early onset neonatal sepsis at Maela refugee camp
2 GBS carriage seroepidemiology and GBS antibody study Infants with neonatal sepsis will be identified clinically They will be assessed and after informed consent is taken from their mother they will have a full septic screen including a complete blood count serum C-reactive protein blood culture lumbar puncture and a deep swab taken from their ear canal If the ear swab is positive for GBS and the blood culture is negative for other pathogens a presumptive diagnosis of EO GBS sepsis will be made The mother will have 5ml blood sample for GBS serotype-specific antibody testing and a vaginal rectal swab obtained if this has not been performed already
Women who consent to take part in the GBS carriage study will during labour have a low vaginal and rectal swab taken which will be processed using the CDC Group B streptococcus guideline Additionally a GBS-specific PCR of the swab will be used to identify culture-negative cases of GBS carriage 5ml of venous blood will be taken from the mother and 5ml of blood taken after delivery from the placenta from the umbilical vein for GBS antibody studies
This study will establish the burden of clinical early onset neonatal sepsis in our population Additionally this study will establish the prevalence of maternal GBS carriage and assess the potential for intrapartum antibiotic prophylaxis for reducing the burden of neonatal sepsis in this setting It will also define the serotypes and antibiotic susceptibility profile of carried and invasive GBS strains
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None