Breastfeeding Rates at the Department of Neonatology of U... | NCT02464579

Studies
Breastfeeding Rates at the Department of Neonatology of University Hospital Cologne

NCT02464579

Sponsor

University Hospital of Cologne

Status

Completed

Last Update Posted

Jan 18, 2020Actual

Enrollment

450Actual

Phase

Not provided

Conditions

Newborn

Interventions

Not provided

Countries

Germany

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

Jan 2020

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

May 1, 2015

Primary Completion Date

Jun 30, 2016Actual

Completion Date

Feb 1, 2017Actual

First Submitted Date

Jun 3, 2015

First Submission Date that Met QC Criteria

Jun 3, 2015

First Posted Date

Jun 8, 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

Jan 13, 2020

Last Update Posted Date

Jan 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Titus Keller, MD, Dr. med. Titus Keller, University Hospital of ColognePrincipal Investigator

Lead Sponsor

University Hospital of CologneOTHER

Collaborators

Not provided

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 objective of this study is to measure the breastfeeding success for all preterm and term newborns in our department of neonatology during the hospital stay and at the age of six months.

Detailed Description

A score was established which combines information on breastfeeding rate and breastmilk feeding rate, and used to monitor daily breastfeeding success.

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

No data available

No data is available for this block.

Enrollment

450Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Breastfeeding Rate	A score was established wich combines informations on breastfeeding rate and breastmilk rate into one value. Of special interest was the score at discharge from the neonatologic center.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Inborn or referred to our Department of Neonatology in the first week of life
Informed consent of both parents or legal guardian

Exclusion Criteria:

No informed consent of parent or legal guardian.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

7 Days

Standard Ages

Child

Study Population

In-patients of the Department of Neonatology of Cologne.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Titus Keller, MD	Neonatology at the University Hospital of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neonatology at University Hospital of Cologne		Cologne		50937	Germany

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided