Donor milk banks: Implementation and Promotion of lactation in German neonatal intensive care units (non-interventional study)
Organizational Data
- DRKS-ID:
- DRKS00024799
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2021-05-04
- Last update in DRKS:
- 2021-05-04
- Registration type:
- Prospective
Acronym/abbreviation of the study
NEO-MILK
URL of the study
Brief summary in lay language
It is undisputed that mother’s milk is the best nutrition for new born infants. Especially for prematurely born infants of a birth weight of less than 1,500g, mother’s milk is critical in terms of further development. In cases where mothers are (temporarily) unable to provide their infants with breast milk, human donor milk should be the preferred alternative. However, due to structural, legal and financial challenges, this is currently only possible within a few German neonatal intensive care units (NICUs). Further, a structured supervision and support of mothers of prematurely born infants regarding lactation has been lacking. Therefore, the NEO-MILK project includes both the systematic promotion of willingness to breastfeed/lactate among mothers of prematurely born infants as well as the establishment of human donor milk banks on level I and level II NICUs. The aim of the project is that every prematurely born infant of a birth weight of less than 1,500g has access to mother’s milk or human donor milk. In terms of registration, the study has been divided into a non-interventional (DRKS00024799) and interventional (DRKS00025058) part.
Brief summary in scientific language
The trial focuses on the status quo of already established human donor milk banks in Germany and surveys all Level I and Level II NICUs regarding potential implementation challenges. Further, the experiences and needs of mothers of prematurely born infants regarding breastfeeding/lactation in the very early postpartum period are explored. These findings provide the basis for the interventional part of the trial (DRKS00025058) which include the development, implementation and evaluation of 1.) a standardised approach on the establishment of human donor milk banks in Germany and 2.) a concept for systematic promotion of the maternal willingness to breastfeed/lactate in NICUs. This includes among others the establishment of human donor milk banks within twelve selected NICUs, trainings for nurses and doctors as well as the development of an app for knowledge transfer. The study combines quantitative and qualitative methods of data collection and analysis (Mixed methods approach). The findings will facilitate the development of a legal and structural foundation for a country-wide standardised establishment of human donor milk banks, thus contribute to improved health care as well as an improved medical outcome of prematurely born infants.
Health condition or problem studied
- ICD10:
- P07.01
- ICD10:
- P07.02
- ICD10:
- P07.10
- ICD10:
- P07.11
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- AP1 - Examination of the status quo and implementation challenges: 1. Survey of already established human donor milk banks: quantitative (n=31), qualitative (n=6 or until theoretical saturation) 2. Survey of Level I and Level II NICU management: quantitative (complete survey: n=220 medical and n=220 nursing management) 3. Survey of mothers of prematurely born infants of a birth weight of less than 1,500g: quantitative (n= 2200), qualitative (n=12 or until theoretical saturation)
Endpoints
- Primary outcome:
- Status quo of already established human donor milk banks (standardised questionnaire, structured qualitative interviews); Implementation challenges of all Level I and Level II NICUs in Germany; Experiences and needs regarding breastfeeding/lactation of mothers of prematurely born infants of a birth weight of less than 1,500g whose children are between 6 and 18 months old at the time of the survey (standardised questionnaire, structured qualitative interviews)
- Secondary outcome:
- none
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- 2021-06-14
- Actual study start date:
- No Entry
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 2700
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Already established human donor milk banks; all Level I and Level II NICUs in Germany; Mothers of prematurely born infants of a birth weight of less than 1,500g whose child is between 6 and 18 months old at the time of the survey
Exclusion Criteria
Birth clinics of level III and level IV; Fathers of prematurely born infants
Addresses
Primary Sponsor
- Address:
- Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft (IMVR) der Humanwissenschaftlichen Fakultät und der Medizinischen Fakultät der Universität zu KölnProf. Dr. Holger PfaffEupener Str. 12950933 KölnGermany
- Telephone:
- 0221/47897101
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.imvr.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft (IMVR) der Humanwissenschaftlichen Fakultät und der Medizinischen Fakultät der Universität zu KölnDr. Nadine ScholtenEupener Str. 12950933 KölnGermany
- Telephone:
- 0221/47897156
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.imvr.de
Contact for Public Queries
- Address:
- Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft (IMVR) der Humanwissenschaftlichen Fakultät und der Medizinischen Fakultät der Universität zu KölnTim OhnhäuserEupener Str. 12950933 KölnGermany
- Telephone:
- 0221/47897103
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://neo-milk.uni-koeln.de/
Principal Investigator
- Address:
- Institut für Medizinsoziologie, Versorgungsforschung und Rehabilitationswissenschaft (IMVR) der Humanwissenschaftlichen Fakultät und der Medizinischen Fakultät der Universität zu KölnDr. Nadine ScholtenEupener Str. 12950933 KölnGermany
- Telephone:
- 0221/47897156
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.imvr.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Gemeinsamer Bundesausschuss - InnovationsausschussGutenbergstraße 1310587 BerlinGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://innovationsfonds.g-ba.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Fakultät der Universität zu KölnGleueler Str. 26950935 KölnGermany
- Telephone:
- +49-221-478 82900
- Fax:
- +40-221-478 82905
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-10-08
- Ethics committee number:
- 20-1547 (Rahmenantrag)
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-01-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- DRKS00025058 - NEO-MILK (Interventioneller Studienteil)
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry