Orientation Effects of Breastfeeding for Mothers | NCT02994810

Studies
Orientation Effects of Breastfeeding for Mothers

NCT02994810

Sponsor

Hospital Moinhos de Vento

Status

Completed

Last Update Posted

Dec 16, 2016Estimated

Enrollment

217Actual

Phase

Not Applicable

Conditions

Breastfeeding

Interventions

Breastfeeding guidance

Countries

Brazil

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

Dec 2016

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

Mar 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Jan 7, 2016

First Submission Date that Met QC Criteria

Dec 13, 2016

First Posted Date

Dec 16, 2016Estimated

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

Dec 13, 2016

Last Update Posted Date

Dec 16, 2016Estimated

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

Description Module

Brief Summary

The benefits of breastfeeding are increasingly known of the population and breastfeeding rates in the country have been increasing, but still are below satisfactory to the Ministry of Health (MH) and the World Health Organization (WHO).

Simple Strategies to guide and support the mother contributes to increasing knowledge about breastfeeding and can have positive impacts on breastfeeding rates.

Detailed Description

Assess the impact of guidance on breastfeeding duration of exclusive breastfeeding in the first six months of a baby's life.

110 pairs of mother / baby - Recruitment: Private Hospital of Porto Alegre.

The first stage was carried out in the maternity - Orientation: Breastfeeding Importance Handle Correct, Positioning mother and baby, socioeconomic data and demographics. For the intervention group held three home visits:

10th day, 1st and 2nd month of the baby's life. At 6 months were made telephone contact for both groups.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

217Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	Guidelines and review of the breastfeeding techniques.	Other: Breastfeeding guidance
Control group	No Intervention	The control group will receive home visits only when the baby is 6 months of life, they will be re-evaluated by the researchers as the practice of exclusive breastfeeding and the technical and nursing management, and will be asked about the main difficulties encountered in maintaining breastfeeding.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Breastfeeding guidance	Other	Breastfeeding guidance	Intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of Breastfeeding for Mothers measured by structured questionnaire		Six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mothers living in the city of Porto Alegre

Exclusion Criteria:

Mothers who test positive for HIV, poor hearing, visual and mental disorders, preterm infants, twin hospitalized

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Salete de matos		Porto Alegre		91215200	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001942	Breast Feeding
D000072458	Orientation, Spatial

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior
D013037	Spatial Behavior

Browse Leaves

Not provided

Browse Branches

Not provided