Non Specific Effects of VaccineNCT03020147
Low Birth Weight Follow-up
An observational study of Non Specific Effects of Vaccine and Bacillus-Calmette-Guerin, run by Bandim Health Project at 1 site in Guinea-Bissau.
Trial summary
The Randomized Control Trail included 4,172 low-birth weight children between February 2008 and September 2013 in Bissau. The children who were included in the RCT and who are living in the Bandim Health Project study area will be visited. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non Specific Effects of Vaccine, Bacillus-Calmette-Guerin, Low Birth Weight
- How many people
- 1,258 participants
- Where
- 1 siteGuinea-Bissau
- Study dates
- 15 Feb 2017to 15 Jan 2021
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Children who participated in the low birth weight trial between 2008 and 2013.
Who may be able to join
- Participation during the low birth weight BCG trial between 2008 and 2013.
Who cannot join
- Not living in the Bandim Health Project's study area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow-up of Low Birth Weight Cohort of 2008-2013
The Randomized Control Trail included 4,172 low-birth weight children between February 2008 and September 2013 in Bissau. The children who were included in the RCT and who are living in the Bandim Health Project study area will be visited. The study assistants will ask about the health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar status of both child and parents will be checked.
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 |
|---|---|---|
| early BCG | Children received BCG soon after their birth between 2008 and 2013. | |
| delayed BCG | Children received BCG when they are 2,5kg between 2008 and 2013. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality differences between group who received early BCG and late BCG
Measured: up to 8 years of age
mortality by parental scar status
Measured: up to 8 years of age
Secondary outcomes (3)
hospitalization rate between early BCG and late BCG group
Measured: last two weeks
consultation rate between early BCG and late BCG group
Measured: last two weeks
medication use between early BCG and late BCG group
Measured: last two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study start15 Feb 2017
- Primary completion15 Dec 2017
- Study completion15 Jan 2021
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 Non Specific Effects of VaccineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bandim Health Project
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020147
- Sponsor's protocol ID
- BandimHP
- Status last verified
- Apr 2021
- First submitted
- 10 Jan 2017
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.
PubMed 21673035Biering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.
PubMed 22189537
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up of Low Birth Weight Cohort of 2008-2013
- ClinicalTrials.gov ID
- NCT03020147
- Acronym / sponsor ID
- BandimHP
- Conditions
- Non Specific Effects of Vaccine, Bacillus-Calmette-Guerin, Low Birth Weight, Maternal Immunisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,258 participants (actual)
- Lead sponsor
- Bandim Health ProjectUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 13 Jan 2017 (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.
The Randomized Control Trail included 4,172 low-birth weight children between February 2008 and September 2013 in Bissau. The children who were included in the RCT and who are living in the Bandim Health Project study area will be visited. The study assistants will ask about the health of the child and of both parents. Furthermore, Bacille Calmette-Guerin (BCG) scar status of both child and parents will be checked.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early BCG | – | –Children received BCG soon after their birth between 2008 and 2013. |
| delayed BCG | – | –Children received BCG when they are 2,5kg between 2008 and 2013. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Children who participated in the low birth weight trial between 2008 and 2013.
Key inclusion criteria (1 listed)
- Participation during the low birth weight BCG trial between 2008 and 2013.
Key exclusion criteria (1 listed)
- Not living in the Bandim Health Project's study area.
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
mortality differences between group who received early BCG and late BCG
Time frame: up to 8 years of age
mortality by parental scar status
Time frame: up to 8 years of age
3 secondary outcomes
hospitalization rate between early BCG and late BCG group
Time frame: last two weeks
consultation rate between early BCG and late BCG group
Time frame: last two weeks
medication use between early BCG and late BCG group
Time frame: last two weeks
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 26 Apr 2021.
- Background: PubMed 21673035Aaby P, Roth A, Ravn H, Napirna BM, Rodrigues A, Lisse IM, Stensballe L, Diness BR, Lausch KR, Lund N, Biering-Sorensen S, Whittle H, Benn CS. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period? J Infect Dis. 2011 Jul 15;204(2):245-52. doi: 10.1093/infdis/jir240.
- Background: PubMed 22189537Biering-Sorensen S, Aaby P, Napirna BM, Roth A, Ravn H, Rodrigues A, Whittle H, Benn CS. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J. 2012 Mar;31(3):306-8. doi: 10.1097/INF.0b013e3182458289.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Non Specific Effects of Vaccine and Bacillus-Calmette-Guerin, run by Bandim Health Project at 1 site in Guinea-Bissau.
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 26 Apr 2021. 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 Guinea-Bissau. 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?
mortality differences between group who received early BCG and late BCG (time frame: up to 8 years of age). The study lists 2 primary outcomes in all. 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 NCT03020147, 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 26 Apr 2021.