Orofacial Difficulties in Rooming-in | NCT01051843

Studies
Orofacial Difficulties in Rooming-in

NCT01051843

Sponsor

Fortaleza University

Status

Completed

Last Update Posted

Jan 20, 2010Estimated

Enrollment

29Actual

Phase

Not provided

Conditions

Orofacial Difficulties in Newborns
Maternal Breastfeeding in Newborns
Newborns in Rooming-in

Interventions

Not provided

Countries

Not provided

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

Aug 2009

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

Aug 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jan 19, 2010

First Submission Date that Met QC Criteria

Jan 19, 2010

First Posted Date

Jan 20, 2010Estimated

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

Jan 19, 2010

Last Update Posted Date

Jan 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 purpose of this study is to identify the orofacial difficulties during the maternal breastfeeding in rooming-in.

Detailed Description

Cross-sectional and quantitative study with sample consisted of 28 dyad present in rooming-in of the Assis Chateaubriand School Motherhood during August and December of 2009.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mothers of the newborns participating in the study, regardless of the gender, ethnic and/or age.

Exclusion Criteria:

newborns who presented oropharyngelarynx structural abnormality, impossibility to feed by mouth and/or exposed in bilispot.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

1 Month

Standard Ages

Child

Study Population

Cross-sectional study of 29 dyads in rooming-in. The data collection consisted in the detection of the main orofacial difficulties during the maternal breastfeeding in rooming-in.

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D003147	Communication Disorders

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided