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Neonatal Sepsis | Neonatal Sepsis and GBS Carriage Study

Neonatal Sepsis research study

What is the primary objective of this study?

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 streptococcus(GBS) 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.

Who is eligible to participate?

Part 1. The contribution of GBS to EO neonatal sepsis at Maela Refugee Camp study 1. Infants, < 7 days of age, who are born to mothers who followed antenatal care at SMRU antenatal clinic, Maela Refugee Camp and have a clinical diagnosis of sepsis 2. Written informed consent from the mother Exclusion criteria: 1. Severe congenital abnormality identified prenatally or at birth 2. Infants less than 28 weeks gestation Part 2. The GBS carriage, seroepidemiology and GBS antibody study Inclusion criteria: 1. Mothers following antenatal care at SMRU antenatal clinic, Maela camp who are 28 - 30 weeks gestation 2. Written informed consent from the mother Exclusion criteria: 1. Mothers receiving antibiotics at the time of sampling

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Neonatal Sepsis

Maternal GBS Carriage

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

InfantsInfants less than 7 days of age with clinical signs of sepsis

MothersMothers following antenatal care at SMRU antenatal clinic, Maela camp who are 28 - 30 weeks gestation

Study Status

Unknown status

Start Date: March 2009

Completed Date: December 2011

Phase:

Type: Observational

Design:

Primary Outcome: Incidence of early onset neonatal sepsis (including the prevalence of culture positive and culture negative EO GBS sepsis)

Secondary Outcome: Perinatal risk factors for early onset neonatal sepsis

Study sponsors, principal investigator, and references

Principal Investigator: Francois Nosten, MD

Lead Sponsor: University of Oxford

Collaborator: Wellcome Trust

More information:https://clinicaltrials.gov/show/NCT00861055

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