Risk Factors of Breastfeeding Study | NCT00195962

Studies
Risk Factors of Breastfeeding Study

NCT00195962

Sponsor

Children's Mercy Hospital Kansas City

Status

Completed

Last Update Posted

Dec 18, 2008Estimated

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

United States

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

May 2008

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

Jun 2004

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 20, 2005Estimated

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 17, 2008

Last Update Posted Date

Dec 18, 2008Estimated

Description Module

Brief Summary

The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed.

Detailed Description

The goal of this study is to identify infants who are at risk for developing problems related to being breast-fed. A previous study identified items that place an infant at a high risk for developing complications related to being breast-fed. The present study will use the same survey and collect data from more participants. These additional participants are necessary to provide statistical analysis for the survey. The survey being developed will assist health care professionals to identify those infants at risk for developing health problems related to being breast-fed and provide care that will minimize the chances of developing complications.

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

1,500Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mothers of healthy infants that are breastfeeding
At least 24 hours post delivery
Mother and baby will be dismissed from the hospital together.

Exclusion Criteria:

Mothers of newborns that are not breastfeeding
Mothers of newborns that are ill and/or will not be dismissed from the hospital at the same time as the mother

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Mothers of healthy infants that are breastfeeding
At least 24 hours post delivery
Mother and baby will be dismissed from the hospital together.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Mercer, RN	Children's Mercy Hospital Kansas City	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Mercy Hospitals and Clinics		Kansas City	Missouri	64108	United States
Truman Medical Center - Hospital Hill

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12410194	Background	Hall RT, Mercer AM, Teasley SL, McPherson DM, Simon SD, Santos SR, Meyers BM, Hipsh NE. A breast-feeding assessment score to evaluate the risk for cessation of breast-feeding by 7 to 10 days of age. J Pediatr. 2002 Nov;141(5):659-64. doi: 10.1067/mpd.2002.129081.

ID	Term
D005247	Feeding Behavior
D001519	Behavior