Neonatal Sepsis and GBS Carriage Study

NCT00861055 | Completed

• 1 other identifier: SMRU0901
• Study Type: observational
• Target: 849
• Locations: 1 country
• Sites: 1

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

• 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
• Through these data assess the potential for intrapartum antibiotic prophylaxis using different strategies for reducing the burden of neonatal sepsis in this setting
• To define the serotypes and antibiotic susceptibility profile of carried and invasive GBS strains
• 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.

Conditions

Neonatal Sepsis

Outcome Measures

Primary Outcomes (1)

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

  7 days after delivery

Secondary Outcomes (4)

• Perinatal risk factors for early onset neonatal sepsis

  7 days after delivery

• Prevalence of maternal GBS carriage

  During labour

• GBS serotype specific antibody prevalence

  During labour

• serotypes and antibiotic susceptibility profile of carried and invasive GBS strains

  During labour

Study Arms (2)

Infants

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

Mothers

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All expectant mothers who follow ANC care at SMRU Maela Refugee Camp and their infants.

You may not qualify if:

• Severe congenital abnormality identified prenatally or at birth
• Infants less than 28 weeks gestation Part 2. The GBS carriage, seroepidemiology and GBS antibody study
• Mothers following antenatal care at SMRU antenatal clinic, Maela camp who are 28 - 30 weeks gestation
• Written informed consent from the mother
• \. Mothers receiving antibiotics at the time of sampling

Sponsors & Collaborators

• University of Oxford: lead
• Wellcome Trust: collaborator

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Location

Related Publications (2)

• Turner C, Turner P, Po L, Maner N, De Zoysa A, Afshar B, Efstratiou A, Heath PT, Nosten F. Group B streptococcal carriage, serotype distribution and antibiotic susceptibilities in pregnant women at the time of delivery in a refugee population on the Thai-Myanmar border. BMC Infect Dis. 2012 Feb 8;12:34. doi: 10.1186/1471-2334-12-34.

  PMID: 22316399 RESULT

• Turner C, Turner P, Hoogenboom G, Aye Mya Thein N, McGready R, Phakaudom K, De Zoysa A, Efstratiou A, Heath PT, Nosten F. A three year descriptive study of early onset neonatal sepsis in a refugee population on the Thailand Myanmar border. BMC Infect Dis. 2013 Dec 21;13:601. doi: 10.1186/1471-2334-13-601.

  PMID: 24359288 RESULT

MeSH Terms

Conditions

Neonatal Sepsis

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francois Nosten, MD

  Shoklo Malaria Research Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 8, 2024

Record last verified: 2016-03

Locations

TH (1)