Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial

Background Human milk, especially mother’s own milk (MOM), is vital for newborns and crucial for very low birthweight (VLBW, <1500 g) preterm infants, who face increased vulnerability. As the production of MOM may be impeded due to preterm birth, it is important to provide lactation support a...

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Main Authors: Angela Kribs, Nicole Ernstmann, Nadine Scholten, Martin Hellmich, Antje Hammer, Eva Mildenberger, Andreas Müller, Dirk Horenkamp-Sonntag, Juliane Köberlein-Neu, Tim Ohnhäuser, Katja Matthias, Jens Ulrich Rüffer, Nicola Gabriela Dymek, Julia Jaschke, Anna Katharina Stirner, Isabella Schwab, Daniel Wiesen, Till Dresbach, Friederike Eyssel, Katharina Lugani, Anne Sunder-Plaßmann, Melanie Klein, Christoph Rupprecht
Format: Article
Language:English
Published: BMJ Publishing Group 2025-02-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/2/e084746.full
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author Angela Kribs
Nicole Ernstmann
Nadine Scholten
Martin Hellmich
Antje Hammer
Eva Mildenberger
Andreas Müller
Dirk Horenkamp-Sonntag
Juliane Köberlein-Neu
Tim Ohnhäuser
Katja Matthias
Jens Ulrich Rüffer
Nicola Gabriela Dymek
Julia Jaschke
Anna Katharina Stirner
Isabella Schwab
Daniel Wiesen
Till Dresbach
Friederike Eyssel
Katharina Lugani
Anne Sunder-Plaßmann
Melanie Klein
Christoph Rupprecht
author_facet Angela Kribs
Nicole Ernstmann
Nadine Scholten
Martin Hellmich
Antje Hammer
Eva Mildenberger
Andreas Müller
Dirk Horenkamp-Sonntag
Juliane Köberlein-Neu
Tim Ohnhäuser
Katja Matthias
Jens Ulrich Rüffer
Nicola Gabriela Dymek
Julia Jaschke
Anna Katharina Stirner
Isabella Schwab
Daniel Wiesen
Till Dresbach
Friederike Eyssel
Katharina Lugani
Anne Sunder-Plaßmann
Melanie Klein
Christoph Rupprecht
collection DOAJ
description Background Human milk, especially mother’s own milk (MOM), is vital for newborns and crucial for very low birthweight (VLBW, <1500 g) preterm infants, who face increased vulnerability. As the production of MOM may be impeded due to preterm birth, it is important to provide lactation support and establish human donor milk (HDM) banks to provide HDM when MOM is fully or initially absent. This protocol describes the design of a study evaluating the effectiveness, implementation and economic aspects of an intervention, which aims to ensure access to MOM or HDM for VLBW infants from the first day of life in German neonatal intensive care units (NICUs).Methods and analysis The hybrid type 1 effectiveness-implementation cluster-randomised controlled trial, using a stepped-wedge design, will be conducted in 15 level I and level II NICUs across Germany over 26 months. VLBW infants and their mothers will receive either standard care or the Neo-MILK intervention according to the NICU’s group status. The primary outcome is the proportion of VLBW infants exclusively fed with MOM at NICU discharge. Secondary outcomes at infant level include feeding patterns, complications, length of stay and frequency of feeding with HDM. Maternal-level secondary outcomes cover lactation/breastfeeding decision and behaviour. A process evaluation and an economic analysis will accompany the study. The data set comprises survey and interview data and routinely collected data from medical records. Statistical analysis will be performed using generalised linear mixed models.Ethics and dissemination Data collection, storage and analysis comply with current data protection regulations. This study has received ethical approval from the Ethics Committee of the Medical Faculty of the University of Cologne and the local ethics committees of the participating NICUs. Results will be disseminated through peer-reviewed publications and on the project website.Trial registration number DRKS00025058.
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spelling doaj-art-26353c36279244389ce6c144b5a8797a2025-02-07T06:00:13ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-084746Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial Angela KribsNicole ErnstmannNadine Scholten0Martin HellmichAntje HammerEva MildenbergerAndreas MüllerDirk Horenkamp-SonntagJuliane Köberlein-Neu1Tim Ohnhäuser2Katja MatthiasJens Ulrich RüfferNicola Gabriela Dymek3Julia Jaschke4Anna Katharina Stirner5Isabella Schwab6Daniel Wiesen7Till Dresbach8Friederike EysselKatharina LuganiAnne Sunder-PlaßmannMelanie KleinChristoph Rupprecht3 Department of Health Services Research, University of Cologne, Koln, Germany1 Centre for Health Economics and Health Services Research, University of Wuppertal, Wuppertal, Germany3 Department of Health Services Research, University of Cologne, Koln, Germany1 Centre for Health Economics and Health Services Research, University of Wuppertal, Wuppertal, Germany1 Centre for Health Economics and Health Services Research, University of Wuppertal, Wuppertal, Germany2 Department of Business Administration and Health Care Management, University of Cologne, Cologne, Germany3 Department of Health Services Research, University of Cologne, Koln, Germany2 Department of Business Administration and Health Care Management, University of Cologne, Cologne, Germany5 Neonatology, University Hospital Bonn, Bonn, GermanyBackground Human milk, especially mother’s own milk (MOM), is vital for newborns and crucial for very low birthweight (VLBW, <1500 g) preterm infants, who face increased vulnerability. As the production of MOM may be impeded due to preterm birth, it is important to provide lactation support and establish human donor milk (HDM) banks to provide HDM when MOM is fully or initially absent. This protocol describes the design of a study evaluating the effectiveness, implementation and economic aspects of an intervention, which aims to ensure access to MOM or HDM for VLBW infants from the first day of life in German neonatal intensive care units (NICUs).Methods and analysis The hybrid type 1 effectiveness-implementation cluster-randomised controlled trial, using a stepped-wedge design, will be conducted in 15 level I and level II NICUs across Germany over 26 months. VLBW infants and their mothers will receive either standard care or the Neo-MILK intervention according to the NICU’s group status. The primary outcome is the proportion of VLBW infants exclusively fed with MOM at NICU discharge. Secondary outcomes at infant level include feeding patterns, complications, length of stay and frequency of feeding with HDM. Maternal-level secondary outcomes cover lactation/breastfeeding decision and behaviour. A process evaluation and an economic analysis will accompany the study. The data set comprises survey and interview data and routinely collected data from medical records. Statistical analysis will be performed using generalised linear mixed models.Ethics and dissemination Data collection, storage and analysis comply with current data protection regulations. This study has received ethical approval from the Ethics Committee of the Medical Faculty of the University of Cologne and the local ethics committees of the participating NICUs. Results will be disseminated through peer-reviewed publications and on the project website.Trial registration number DRKS00025058.https://bmjopen.bmj.com/content/15/2/e084746.full
spellingShingle Angela Kribs
Nicole Ernstmann
Nadine Scholten
Martin Hellmich
Antje Hammer
Eva Mildenberger
Andreas Müller
Dirk Horenkamp-Sonntag
Juliane Köberlein-Neu
Tim Ohnhäuser
Katja Matthias
Jens Ulrich Rüffer
Nicola Gabriela Dymek
Julia Jaschke
Anna Katharina Stirner
Isabella Schwab
Daniel Wiesen
Till Dresbach
Friederike Eyssel
Katharina Lugani
Anne Sunder-Plaßmann
Melanie Klein
Christoph Rupprecht
Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial
BMJ Open
title Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial
title_full Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial
title_fullStr Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial
title_full_unstemmed Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial
title_short Structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in German NICUs (Neo-MILK): protocol for a hybrid type 1 effectiveness-implementation cluster-randomised controlled trial
title_sort structured lactation support for mothers of very low birthweight preterm infants and establishment of human donor milk banks in german nicus neo milk protocol for a hybrid type 1 effectiveness implementation cluster randomised controlled trial
url https://bmjopen.bmj.com/content/15/2/e084746.full
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