Upper Respiratory Tract InfectionsNCT02361164
Birth Cohort Study for Respiratory Infections
An observational study of Upper Respiratory Tract Infections, run by Société des Produits Nestlé (SPN) at 1 site in Bangladesh.
Trial summary
The primary objectives are to evaluate relationship between nasopharyngeal microbial colonization and the occurrence of AOM or pneumonia in infants. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- How many people
- 300 participants
- Where
- 1 siteBangladesh
- Study dates
- Jul 2012to Mar 2017
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Community sample
Who may be able to join
- Age: 18-35 years
- Parity: any but with history of previous normal delivery
- Weight: Body Mass Index greater than 18.5 but less than 35
- Past obstetric history: Uncomplicated pregnancy, unremarkable medical and obstetric conditions
- Current pregnancy: Uneventful progression of pregnancy
- General health: Normal health related functional status during pregnancy
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- Singleton pregnancy as determined by clinical examination and/or by ultrasonography
- Cephalic presentation as determined by abdominal clinical examination
- Expected to have normal pregnancy related outcome
- Written informed consent
Who cannot join
- Medical history: Known history of diabetes, hypertension, or any systemic disorder
- Gynecological history: History of major gynecological problem/treatment
- Complications in previous pregnancy
- Previous obstetric cholestasis
- Previous acute fatty liver disease
- Conditions during current pregnancy
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- RhD negative mother
- APH/Placental abruption
- Placenta Praevia
- Unstable lie
- Multiple pregnancy
- Pregnancy induced hypertension (systolic > 140 mm of Hg, diastolic > 90 mm of Hg)
- Severe pre-eclampsia or eclampsia
- Gestational diabetes
- Onstetric cholestasis
- Current history of drug/alcohol abuse
- BMI of less than 18.5 or more than 35. Severe pallor as detected clinically or by HB level (< 7 gm/dL), and oedema
- Blood samples drawn and tested for VDRL (Positive VDRL) Cephalopelvic disproportion (CPD)
- History of taking antibiotic within 3 weeks prior to this study
- Patient unwilling to comply with study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Two-year Observational Study to Evaluate the Effect of Bacterial Colonisation of the Nasopharynx on the Occurence of Acute Respiratory Infections in a Birth Cohort of Children and Their Mothers
The primary objectives are to evaluate relationship between nasopharyngeal microbial colonization and the occurrence of AOM or pneumonia in infants.
- Conditions
- Upper Respiratory Tract Infections
- Medical subject headings
- Respiratory Tract Infections
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 |
|---|---|---|
| Mother/child pair | Mother/child pair. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)
Measured: 2 years
Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota
Measured: 2 years
Risk factors for recurrent Upper Respiratory Track Infection in terms of bacteria or virus, nutritional and immune status, as well as epidemiological factors
Measured: 2 years
Secondary outcomes (2)
Incidence of maternal urogenital infection
Measured: 2 years
Birth outcome
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJul 2012
- Primary completionSep 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shafiqul Alam Sarker, M.D., Principal investigator, International Center for Diarrheal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02361164
- Sponsor's protocol ID
- 11.11.NRC
- Status last verified
- Apr 2018
- First submitted
- 6 Feb 2015
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Two-year Observational Study to Evaluate the Effect of Bacterial Colonisation of the Nasopharynx on the Occurence of Acute Respiratory Infections in a Birth Cohort of Children and Their Mothers
- ClinicalTrials.gov ID
- NCT02361164
- Acronym / sponsor ID
- 11.11.NRC
- Conditions
- Upper Respiratory Tract Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2012 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 11 Feb 2015 (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 primary objectives are to evaluate relationship between nasopharyngeal microbial colonization and the occurrence of AOM or pneumonia in infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother/child pair | – | –Mother/child pair. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample
Key inclusion criteria (10 listed)
- Age: 18-35 years
- Parity: any but with history of previous normal delivery
- Weight: Body Mass Index greater than 18.5 but less than 35
- Past obstetric history: Uncomplicated pregnancy, unremarkable medical and obstetric conditions
- Current pregnancy: Uneventful progression of pregnancy
Key exclusion criteria (20 listed)
- Medical history: Known history of diabetes, hypertension, or any systemic disorder
- Gynecological history: History of major gynecological problem/treatment
- Complications in previous pregnancy
- Previous obstetric cholestasis
- Previous acute fatty liver disease
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 respiratory disease (Acute Otitis Media, Acute Respiratory Infection)
Time frame: 2 years
Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota
Time frame: 2 years
Risk factors for recurrent Upper Respiratory Track Infection in terms of bacteria or virus, nutritional and immune status, as well as epidemiological factors
Time frame: 2 years
2 secondary outcomes
Incidence of maternal urogenital infection
Time frame: 2 years
Birth outcome
Time frame: 2 years
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 9 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Shafiqul Alam Sarker, M.D. principal investigator
International Center for Diarrheal Disease Research, Bangladesh
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 Upper Respiratory Tract Infections, run by Société des Produits Nestlé (SPN) 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 10 inclusion and 20 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 9 Apr 2018. 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?
Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection) (time frame: 2 years). The study lists 3 primary outcomes in all. 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 9 Apr 2018.