Birth Cohort Study for Respiratory Infections | NCT02361164

Studies
Birth Cohort Study for Respiratory Infections

NCT02361164

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Apr 9, 2018Actual

Enrollment

300Actual

Phase

Not provided

Conditions

Upper Respiratory Tract Infections

Interventions

Not provided

Countries

Bangladesh

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012Actual

Primary Completion Date

Sep 2016Actual

Completion Date

Mar 2017Actual

First Submitted Date

Feb 6, 2015

First Submission Date that Met QC Criteria

Feb 6, 2015

First Posted Date

Feb 11, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2018

Last Update Posted Date

Apr 9, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Actual

Label	Type	Description	Intervention Names
Mother/child pair		Mother/child pair.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)		2 years
Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota		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		2 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of maternal urogenital infection		2 years
Birth outcome		2 years

Other Outcomes

Measure	Description	Time Frame
Evaluation of FUT2/3 polymorphism and association with infant health outcomes	Analysis on saliva samples	One time point during the study
Incidence of diarrhea and evaluation of gut health in infants

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Community sample

Sampling Method

Non-Probability Sample

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases