Neonatal SepsisNSSNCT00861055
Neonatal Sepsis and GBS Carriage Study
An observational study of Neonatal Sepsis, run by University of Oxford at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neonatal Sepsis
- How many people
- 849 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2009to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All expectant mothers who follow ANC care at SMRU Maela Refugee Camp and their infants.
Who may be able to join
- Mothers following antenatal care at SMRU antenatal clinic, Maela camp who are 28 - 30 weeks gestation
- Written informed consent from the mother
Who cannot join
- Severe congenital abnormality identified prenatally or at birth
- Infants less than 28 weeks gestation Part 2. The GBS carriage, seroepidemiology and GBS antibody study
- 1. Mothers receiving antibiotics at the time of sampling
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read more
- 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
- 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.
Read the 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:
- Contribution of GBS to early onset neonatal sepsis at Maela refugee camp
- 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.
- Conditions
- Neonatal Sepsis
- Medical subject headings
- Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of early onset neonatal sepsis (including the prevalence of culture positive and culture negative EO GBS sepsis)
Measured: 7 days after delivery
Secondary outcomes (4)
Perinatal risk factors for early onset neonatal sepsis
Measured: 7 days after delivery
Prevalence of maternal GBS carriage
Measured: During labour
GBS serotype specific antibody prevalence
Measured: During labour
serotypes and antibiotic susceptibility profile of carried and invasive GBS strains
Measured: During labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neonatal SepsisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 849 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Francois Nosten, MD, Principal investigator, Shoklo Malaria Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861055
- Sponsor's protocol ID
- SMRU0901
- Acronym
- NSS
- Status last verified
- Mar 2016
- First submitted
- 12 Mar 2009
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22316399Turner 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.
PubMed 24359288
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00861055
- Acronym / sponsor ID
- NSS / SMRU0901
- Conditions
- Neonatal Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 849 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Wellcome Trust
- Study start
- Mar 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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.
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:
- Contribution of GBS to early onset neonatal sepsis at Maela refugee camp
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All expectant mothers who follow ANC care at SMRU Maela Refugee Camp and their infants.
Key inclusion criteria (2 listed)
- Mothers following antenatal care at SMRU antenatal clinic, Maela camp who are 28 - 30 weeks gestation
- Written informed consent from the mother
Key exclusion criteria (3 listed)
- Severe congenital abnormality identified prenatally or at birth
- Infants less than 28 weeks gestation Part 2. The GBS carriage, seroepidemiology and GBS antibody study
- 1. Mothers receiving antibiotics at the time of sampling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of early onset neonatal sepsis (including the prevalence of culture positive and culture negative EO GBS sepsis)
Time frame: 7 days after delivery
4 secondary outcomes
Perinatal risk factors for early onset neonatal sepsis
Time frame: 7 days after delivery
Prevalence of maternal GBS carriage
Time frame: During labour
GBS serotype specific antibody prevalence
Time frame: During labour
serotypes and antibiotic susceptibility profile of carried and invasive GBS strains
Time frame: During labour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Results publication: PubMed 22316399Turner 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.
- Results publication: PubMed 24359288Turner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francois Nosten, MD principal investigator
Shoklo Malaria Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Sepsis, run by University of Oxford at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of early onset neonatal sepsis (including the prevalence of culture positive and culture negative EO GBS sepsis) (time frame: 7 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00861055, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.