- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464579
Breastfeeding Rates at the Department of Neonatology of University Hospital Cologne (BFRUHC)
January 13, 2020 updated by: Titus Keller, MD, University Hospital of Cologne
Prospective Inquiry of Breastfeeding Success at the Department of Neonatology of University Hospital of Cologne and Analysis of Influencing Factors
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.
Study Overview
Status
Completed
Conditions
Detailed Description
A score was established which combines information on breastfeeding rate and breastmilk feeding rate, and used to monitor daily breastfeeding success.
Study Type
Observational
Enrollment (Actual)
450
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cologne, Germany, 50937
- Neonatology at University Hospital of Cologne
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 week (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
In-patients of the Department of Neonatology of Cologne.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breastfeeding Rate
Time Frame: 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Titus Keller, MD, Neonatology at the University Hospital of Cologne
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Actual)
June 30, 2016
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
June 3, 2015
First Submitted That Met QC Criteria
June 3, 2015
First Posted (Estimate)
June 8, 2015
Study Record Updates
Last Update Posted (Actual)
January 18, 2020
Last Update Submitted That Met QC Criteria
January 13, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- UHC-N-15-013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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