Birth Cohort Study for Respiratory Infections

NCT ID: NCT02361164

Last Updated: 2018-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-03-31

Brief Summary

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

Detailed Description

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Conditions

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Upper Respiratory Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mother/child pair

Mother/child pair.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shafiqul Alam Sarker, M.D.

Role: PRINCIPAL_INVESTIGATOR

International Center for Diarrheal Disease Research, Bangladesh

Locations

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International Center for Diarrheal Disease Research

Dhaka, , Bangladesh

Site Status

Countries

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Bangladesh

Other Identifiers

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11.11.NRC

Identifier Type: -

Identifier Source: org_study_id

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