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Birth Cohort Study for Respiratory Infections

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ClinicalTrials.gov Identifier: NCT02361164
Recruitment Status : Completed
First Posted : February 11, 2015
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

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
Upper Respiratory Tract Infections

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 : July 2012
Actual Primary Completion Date : September 2016
Actual Study Completion Date : March 2017

Group/Cohort
Mother/child pair
Mother/child pair.



Primary Outcome Measures :
  1. Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection) [ Time Frame: 2 years ]
  2. Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota [ Time Frame: 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 [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Incidence of maternal urogenital infection [ Time Frame: 2 years ]
  2. Birth outcome [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Evaluation of FUT2/3 polymorphism and association with infant health outcomes [ Time Frame: One time point during the study ]
    Analysis on saliva samples

  2. Incidence of diarrhea and evaluation of gut health in infants [ Time Frame: 2 years ]
    Analysis of fecal samples


Biospecimen Retention:   Samples With DNA
Blood samples, clinical samples for bacterial and viral isolates


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361164


Locations
Bangladesh
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

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02361164     History of Changes
Other Study ID Numbers: 11.11.NRC
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases