NewbornBFRUHCNCT02464579
Breastfeeding Rates at the Department of Neonatology of University Hospital Cologne
An observational study of Newborn, run by University Hospital of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Newborn
- How many people
- 450 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2015to 1 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: In-patients of the Department of Neonatology of Cologne.
Who may be able to join
- Inborn or referred to our Department of Neonatology in the first week of life
- Informed consent of both parents or legal guardian
Who cannot join
- No informed consent of parent or legal guardian.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
A score was established which combines information on breastfeeding rate and breastmilk feeding rate, and used to monitor daily breastfeeding success.
- Conditions
- Newborn
- Keywords
- breastfeeding rate, preterm infant, neonatal intensive care unit
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study start1 May 2015
- Primary completion30 Jun 2016
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Titus Keller, MD, University Hospital of Cologne
- Investigators
- Titus Keller, MD, Principal investigator, Neonatology at the University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464579
- Sponsor's protocol ID
- UHC-N-15-013
- Acronym
- BFRUHC
- Status last verified
- Jan 2020
- First submitted
- 3 Jun 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Inquiry of Breastfeeding Success at the Department of Neonatology of University Hospital of Cologne and Analysis of Influencing Factors
- ClinicalTrials.gov ID
- NCT02464579
- Acronym / sponsor ID
- BFRUHC / UHC-N-15-013
- Conditions
- Newborn
- Keywords
- breastfeeding rate, preterm infant, neonatal intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 1 May 2015
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In-patients of the Department of Neonatology of Cologne.
Key inclusion criteria (2 listed)
- Inborn or referred to our Department of Neonatology in the first week of life
- Informed consent of both parents or legal guardian
Key exclusion criteria (1 listed)
- No informed consent of parent or legal guardian.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Titus Keller, MD principal investigator
Neonatology at the University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.