SepsisNCT01333982
Neonatal Sepsis, Evaluation, Bangladesh
A study testing Amoxycillin, Gentamicin and Counselling in people with Sepsis, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal period), and a substantial proportion of these deaths are due to infections (sepsis). Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- Amoxycillin, Gentamicin and Counselling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteBangladesh
- Study dates
- Apr 2010to Dec 2013
- Phase
- Interventional
- 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 Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- development of danger signs of neonatal sepsis during neonatal period
Who cannot join
- developing signs not in neonatal period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a on Community-Based Management of Neonatal Sepsis
More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal period), and a substantial proportion of these deaths are due to infections (sepsis). According to the recently formulated Bangladesh National Neonatal Health Strategy (NNHS), the Government of Bangladesh is committed to improve access to quality management of neonatal infections. The strategy emphasizes that health service providers at all levels acquire the skills for managing sepsis.
Responding to the recommendations in the National Neonatal Health Strategy, this operations research seeks to evaluate alternative approaches for the management of neonatal sepsis in the community. The evaluation will focus on assessing intervention coverage, provider quality of care, and referral and referral compliance, and will undertake cost-benefit analysis of community-based neonatal sepsis management. The programme and evaluation will be within the existing health service delivery system in Bangladesh and is thus designed to inform the effective scaling up of neonatal sepsis management and contribute to the implementation of the NNHS. The interventions to be evaluated will be nested in the Maternal, Neonatal and Child Survival (MNCS) programme being implemented by the Government of Bangladesh, in partnership with and supported by UNICEF, and several national NGOs.
Read more
This operations research is being implemented by the Government of Bangladesh in collaboration with UNICEF, SNL - Save the Children (USA), Bangladesh Perinatal Society, and ICDDR,B. It will take place in four MNCS programme upazilas, where 10 unions will be randomly selected for intervention and 10 unions will be comparison. The intervention consists of training of community health workers, village doctors and health facility workers on managing neonatal sepsis in addition to essential newborn care training. In the comparison areas the health workers will only receive essential newborn care training.
The intervention and evaluation will continue for at least 18 months, with rolling surveys and two special surveys at 6 and 12 months into the project. The rolling surveys will look at intervention coverage, care-seeking, and referral and referral compliance, while the two special surveys will assess provider performance, referral compliance, and quality of care. In addition, the investigators will document implementation processes to understand what worked and what did not and why.
Read the detailed description
Three to four MNCS programme upazilas will be purposively selected for this study in consultation with GoB and partners. The likely districts from where the three to four upazilas will be selected include Sunamganj, Kishoreganj, Bandarban and Sherpur. However, this may change depending on GoB/UNICEF decisions about MNCS scale-up. The upazilas will be selected considering presence of NGO partners with the ability to implement the intervention, start of MNCS in the upazilas by 2009 and no overlap with other similar programmes research projects. Twenty unions (average population of about 20,000) will be identified from the selected upazilas and randomly assigned to intervention or comparison. Unions with substantial urban populations will be excluded. In order to achieve balance in randomisation across upazilas, the investigators will make efforts to select an even number of unions from the selected upazilas.
Study design
A cluster-randomised design will be used. Of the 20 selected unions in the selected sub-districts/upazilas, 10 will be randomly assigned to intervention and 10 to comparison, that is, about 200,000 population (~40,000 households) in each arm. In both intervention and comparison unions, the common MNCS intervention package will be uniformly implemented, which includes training of community-based health workers on essential newborn care. Details of the MNCS intervention package and delivery systems can be found in Annex I. All the MNCS upazilas have also already implemented facility-based IMCI.
The objective of randomisation is to ensure balance between intervention and comparison areas in terms of population and geographical characteristics and coverage of health interventions and programmes. The sampling units (unions) will be stratified according to upazila. If any union has a total population of less then 12,000 (the minimum required to obtain an adequate sample of neonates) they will either be excluded or if such exclusion results in fewer than 20 unions being available for randomisation then two such small unions will be merged and considered as a single sampling unit. Equal number of unions for intervention or comparison will be selected from each upazila. Within each upazila, unions will be paired on distance from the upazila health complex and members of each pair be randomly selected for intervention or comparison.
In the intervention unions, in addition to routine MNCS services, services for the management of neonatal sepsis will be made available in the community, targeting all pregnant women and newborns born within the study period. Community-based management of neonatal sepsis will be provided by three types of care providers: community health workers, village doctors and community clinic care providers.
The intervention and evaluation will continue for at least 18 months. Evaluation will be ongoing and include rolling household surveys to assess intervention coverage and care-seeking and referral compliance practices. In addition, two special surveys will be conducted to assess provider performance, referral compliance, quality of care at the different levels of care, and incremental program and household costs. The first special survey will be conducted at 6 months after the implementation of the intervention and then again at 12 months. The first round of rolling survey will also include a sample of newborns born in the previous 12 months to assess baseline care-seeking patterns and coverage for neonatal sepsis.
- Conditions
- Sepsis
- Being tested
- Amoxycillin, Gentamicin, Counselling
- Keywords
- Neonatal Sepsis, Evaluation, Bangladesh, Drying, Wrapping, Bathing
- Medical subject headings
- Sepsis, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxycillin, GentamicinOther
If referral fails, community management of neonatal sepsis according to clinical algorithm.
CounsellingOther
counselling of management of neonatal sepsis in the community according to clinical algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Referral compliance | Experimental | Health workers will receive a basic maternal, newborn and child health training under the MNCS programme. Newborn sepsis management training will be organised for the study. The Bangladesh Perinatal Society (BPS) will take the lead in developing and implementing the training programme with support from Saving Newborn Lives (SNL) and other partners.Referral slips will be used in the intervention unions for all the sick newborns identified so that they seek care on a timely fashion. Receives: Other: Amoxycillin, Gentamicin |
| Neonatal sepsis | Experimental | Existing health delivery systems in the community level in managing neonatal sepsis. Receives: Other: Counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appropriate management of all cases of neonatal sepsis in the community by community level health care provider
Neonatal Sepsis cases, if referred, received pre-referral antibiotic and complied with referred places, or if managed on site, managed by community level health care providers trained on neonatal sepsis management and received appropriate antibiotics and minimum course of antibiotics
Measured: 18 months
Secondary outcomes (3)
Newborns will be dried and wrapped immediately after birth
Increase knowledge of caregiver regarding drying and wrapping immediately after birth
Measured: 18 months
Newborns receiving breast feeding within one hour after birth
Increased knowledge of caregivers regarding breast feeding of newborns within one hour after birth
Measured: 18 months
Newborns first bathed at least three days after birth
Increase knowledge of caregiver regarding first-bathing of newborns at least three days after birth
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Johns Hopkins Bloomberg School of Public Health
- Responsible party
- Sponsor
- Investigators
- Shams El Arifeen, MBBS, DrPh, Principal investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333982
- Sponsor's protocol ID
- PR-09056
- Status last verified
- Apr 2011
- First submitted
- 12 Oct 2010
- Last updated
- 30 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a on Community-Based Management of Neonatal Sepsis
- ClinicalTrials.gov ID
- NCT01333982
- Acronym / sponsor ID
- PR-09056
- Conditions
- Sepsis
- Keywords
- Neonatal Sepsis, Evaluation, Bangladesh, Drying, Wrapping, Bathing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh, Johns Hopkins Bloomberg School of Public Health
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Apr 2011 (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.
More than half of under-five deaths in Bangladesh occur in the first month of life (neonatal period), and a substantial proportion of these deaths are due to infections (sepsis). According to the recently formulated Bangladesh National Neonatal Health Strategy (NNHS), the Government of Bangladesh is committed to improve access to quality management of neonatal infections. The strategy emphasizes that health service providers at all levels acquire the skills for managing sepsis.
Responding to the recommendations in the National Neonatal Health Strategy, this operations research seeks to evaluate alternative approaches for the management of neonatal sepsis in the community. The evaluation will focus on assessing intervention coverage, provider quality of care, and referral and referral compliance, and will undertake cost-benefit analysis of community-based neonatal sepsis management. The programme and evaluation will be within the existing health service delivery system in Bangladesh and is thus designed to inform the effective scaling up of neonatal sepsis management and contribute to the implementation of the NNHS. The interventions to be evaluated will be nested in the Maternal, Neonatal and Child Survival (MNCS) programme being implemented by the Government of Bangladesh, in partnership with and supported by UNICEF, and several national NGOs.
This operations research is being implemented by the Government of Bangladesh in collaboration with UNICEF, SNL - Save the Children (USA), Bangladesh Perinatal Society, and ICDDR,B. It will take place in four MNCS programme upazilas, where 10 unions will be randomly selected for intervention and 10 unions will be comparison. The intervention consists of training of community health workers, village doctors and health facility workers on managing neonatal sepsis in addition to essential newborn care training. In the comparison areas the health workers will only receive essential newborn care training.
The intervention and evaluation will continue for at least 18 months, with rolling surveys and two special surveys at 6 and 12 months into the project. The rolling surveys will look at intervention coverage, care-seeking, and referral and referral compliance, while the two special surveys will assess provider performance, referral compliance, and quality of care. In addition, the investigators will document implementation processes to understand what worked and what did not and why.
Detailed description
Three to four MNCS programme upazilas will be purposively selected for this study in consultation with GoB and partners. The likely districts from where the three to four upazilas will be selected include Sunamganj, Kishoreganj, Bandarban and Sherpur. However, this may change depending on GoB/UNICEF decisions about MNCS scale-up. The upazilas will be selected considering presence of NGO partners with the ability to implement the intervention, start of MNCS in the upazilas by 2009 and no overlap with other similar programmes research projects. Twenty unions (average population of about 20,000) will be identified from the selected upazilas and randomly assigned to intervention or comparison. Unions with substantial urban populations will be excluded. In order to achieve balance in randomisation across upazilas, the investigators will make efforts to select an even number of unions from the selected upazilas.
Study design
A cluster-randomised design will be used. Of the 20 selected unions in the selected sub-districts/upazilas, 10 will be randomly assigned to intervention and 10 to comparison, that is, about 200,000 population (~40,000 households) in each arm. In both intervention and comparison unions, the common MNCS intervention package will be uniformly implemented, which includes training of community-based health workers on essential newborn care. Details of the MNCS intervention package and delivery systems can be found in Annex I. All the MNCS upazilas have also already implemented facility-based IMCI.
The objective of randomisation is to ensure balance between intervention and comparison areas in terms of population and geographical characteristics and coverage of health interventions and programmes. The sampling units (unions) will be stratified according to upazila. If any union has a total population of less then 12,000 (the minimum required to obtain an adequate sample of neonates) they will either be excluded or if such exclusion results in fewer than 20 unions being available for randomisation then two such small unions will be merged and considered as a single sampling unit. Equal number of unions for intervention or comparison will be selected from each upazila. Within each upazila, unions will be paired on distance from the upazila health complex and members of each pair be randomly selected for intervention or comparison.
In the intervention unions, in addition to routine MNCS services, services for the management of neonatal sepsis will be made available in the community, targeting all pregnant women and newborns born within the study period. Community-based management of neonatal sepsis will be provided by three types of care providers: community health workers, village doctors and community clinic care providers.
The intervention and evaluation will continue for at least 18 months. Evaluation will be ongoing and include rolling household surveys to assess intervention coverage and care-seeking and referral compliance practices. In addition, two special surveys will be conducted to assess provider performance, referral compliance, quality of care at the different levels of care, and incremental program and household costs. The first special survey will be conducted at 6 months after the implementation of the intervention and then again at 12 months. The first round of rolling survey will also include a sample of newborns born in the previous 12 months to assess baseline care-seeking patterns and coverage for neonatal sepsis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referral compliance | Experimental | Other: Amoxycillin, GentamicinHealth workers will receive a basic maternal, newborn and child health training under the MNCS programme. Newborn sepsis management training will be organised for the study. The Bangladesh Perinatal Society (BPS) will take the lead in developing and implementing the training programme with support from Saving Newborn Lives (SNL) and other partners.Referral slips will be used in the intervention unions for all the sick newborns identified so that they seek care on a timely fashion. |
| Neonatal sepsis | Experimental | Other: CounsellingExisting health delivery systems in the community level in managing neonatal sepsis. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- development of danger signs of neonatal sepsis during neonatal period
Key exclusion criteria (1 listed)
- developing signs not in neonatal period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxycillin, GentamicinIf referral fails, community management of neonatal sepsis according to clinical algorithm. | Other | Referral compliance |
| Counsellingcounselling of management of neonatal sepsis in the community according to clinical algorithm. | Other | Neonatal sepsis |
Primary outcome
Appropriate management of all cases of neonatal sepsis in the community by community level health care provider
Time frame: 18 months
Neonatal Sepsis cases, if referred, received pre-referral antibiotic and complied with referred places, or if managed on site, managed by community level health care providers trained on neonatal sepsis management and received appropriate antibiotics and minimum course of antibiotics
3 secondary outcomes
Newborns will be dried and wrapped immediately after birth
Time frame: 18 months
Newborns receiving breast feeding within one hour after birth
Time frame: 18 months
Newborns first bathed at least three days after birth
Time frame: 18 months
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 30 Oct 2014.
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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.
Shams El Arifeen, MBBS, DrPh principal investigator
International Centre for Diarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxycillin, Gentamicin and Counselling in people with Sepsis, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 1 inclusion and 1 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 30 Oct 2014. 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 Bangladesh. 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?
Appropriate management of all cases of neonatal sepsis in the community by community level health care provider (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2014.