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Birth Cohort Study for Respiratory Infections

Sponsor
Nestlé (Industry)
Overall Status
Completed
CT.gov ID
NCT02361164
Collaborator
(none)
300
Enrollment
1
Location
56
Actual Duration (Months)
5.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objectives are to evaluate relationship between nasopharyngeal microbial colonization and the occurrence of AOM or pneumonia in infants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jul 1, 2012
    Actual Primary Completion Date :
    Sep 1, 2016
    Actual Study Completion Date :
    Mar 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Mother/child pair

    Mother/child pair.

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection) [2 years]

    2. Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota [2 years]

    3. Risk factors for recurrent Upper Respiratory Track Infection in terms of bacteria or virus, nutritional and immune status, as well as epidemiological factors [2 years]

    Secondary Outcome Measures

    1. Incidence of maternal urogenital infection [2 years]

    2. Birth outcome [2 years]

    Other Outcome Measures

    1. Evaluation of FUT2/3 polymorphism and association with infant health outcomes [One time point during the study]

      Analysis on saliva samples

    2. Incidence of diarrhea and evaluation of gut health in infants [2 years]

      Analysis of fecal samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 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

    • 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

    Exclusion Criteria:

    • 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

    1. RhD negative mother

    2. APH/Placental abruption

    3. Placenta Praevia

    4. Unstable lie

    5. Multiple pregnancy

    6. Pregnancy induced hypertension (systolic > 140 mm of Hg, diastolic > 90 mm of Hg)

    7. Severe pre-eclampsia or eclampsia

    8. Gestational diabetes

    9. Onstetric cholestasis

    10. Current history of drug/alcohol abuse

    11. BMI of less than 18.5 or more than 35. Severe pallor as detected clinically or by HB level (< 7 gm/dL), and oedema

    12. Blood samples drawn and tested for VDRL (Positive VDRL) Cephalopelvic disproportion (CPD)

    13. History of taking antibiotic within 3 weeks prior to this study

    14. Patient unwilling to comply with study protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 International Center for Diarrheal Disease Research Dhaka Bangladesh

    Sponsors and Collaborators

    • Nestlé

    Investigators

    • Principal Investigator: Shafiqul Alam Sarker, M.D., International Center for Diarrheal Disease Research, Bangladesh

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nestlé
    ClinicalTrials.gov Identifier:
    NCT02361164
    Other Study ID Numbers:
    • 11.11.NRC
    First Posted:
    Feb 11, 2015
    Last Update Posted:
    Apr 9, 2018
    Last Verified:
    Apr 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Apr 9, 2018