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.

Abstract Background Pump-dependent mothers of very low birth weight (VLBW, < 1500g) infants experience specific challenges achieving sufficient milk supply in the neonatal intensive care unit (NICU) and are therefore less frequently able to achieve (exclusive) breast milk feeding. Stress due to the limitations on participating in the infant’s care may contribute to this problem. Some explorative studies suggest that pressure to provide milk may be an additional stressor in mothers. However, the type of pressure to provide milk perceived by mothers of VLBW infants has rarely been examined. Methods A retrospective and anonymous questionnaire was conducted with mothers of VLBW infants aged 6 to 24 months at the time of data collection. Quantitative data and written comments were used to examine the mothers’ perceptions. Descriptive and bivariate tests (Spearman´s rho, Pearson’s chi2) were performed to show correlations between pressure to provide breast milk, parental stress (PSS:NICU: role alteration subscale), milk volume, and maternal factors. Pressure to provide milk was measured through two self-developed single items to differentiate between internal and external pressures. Results Data of n = 533 mothers of VLBW infants was analysed. More than 70% of the mothers agreed that they pressured themselves to provide milk for their infant. In contrast, 34% of the mothers agreed that they felt pressure from outside to provide milk. Higher milk volume 14 days post-partum was significantly correlated with less internal (Spearman´s rho = 0.2017, p = 0.000) and less external pressure to provide milk (Spearman´s rho = 0.2991; p = 0.000). Higher PSS:NICU parental role alteration scores were significantly correlated with more internal (Spearman´s rho = -0.2865, p = 0.000) and more external pressure to provide milk (Spearman´s rho = -0.1478; p = 0.002). Milk volume 14 days post-partum and the PSS:NICU were not significantly correlated (Spearman´s rho = -0.0190; p = 0.701). Qualitative analyses highlighted these results and enhanced the bidirectional relationships between maternal pressure to provide milk and milk volume. Conclusions Especially internal pressure to provide milk is perceived by many mothers, being mutually dependent on milk supply and parental stress. Pressure to provide milk may be an important factor to decrease maternal stress in the NICU and, therefore, lead to more positive pumping and breastfeeding experiences. More research and validated instruments are needed to adequately measure pressure to provide milk with its different psychological, social, and environmental dimensions.

Hintergrund Die WHO empfiehlt die ausschließliche Ernährung von Frühgeborenen mit Muttermilch in den ersten sechs Lebensmonaten1. Besonders Frühgeborene mit einem Geburtsgewicht von weniger als 1500 Gramm (vlbw; very low birthweight) profitieren davon, obwohl gerade diese Mütter aufgrund der Notwendigkeit zum Abpumpen und den erschwerten Bedingungen in den ersten Wochen Schwierigkeiten haben, genügend Milch zu bilden. Eine sechsmonatige Stilldauer (Versorgung mit Muttermilch; abgepumpt und/oder gestillt) können insgesamt nur die wenigsten Mütter vorweisen2. Zu den relevanten Faktoren für einen vorzeitigen Stillabbruch, die in früheren Studien mit Müttern reifer Neugeborener ermittelt wurden, gehören eine geringe Muttermilchmenge und ein niedriger Bildungsstand3. Für den spezifischen Fall der vlbw Frühgeborenen in Deutschland besteht noch Forschungsbedarf.

Hintergrund Als entscheidender Prädiktor für die Wahrscheinlichkeit, dass ein Frühgeborenes mit Muttermilch von der NICU entlassen wird, gilt eine Milchmenge von mindestens 500 ml/d am 14 Tage p.p. [1]. Als entscheidender Faktor für eine erfolgreiche Initiierung der Laktation gilt das frühzeitige und regelmäßige Entleeren der Brust durch Abpumpen / manuelle Entleerung [2]. Der Geburtsmodus, wie auch die damit verbundene Narkoseart, kann einen Einfluss auf den Zeitpunkt des ersten Abpumpens haben und somit die Initiierung der Laktation verzögern. Massive Blutverluste und hierdurch die notwendige Gabe von Bluttransfusionen, sowie die Notwendigkeit einer intensivmedizinischen Versorgung der Mutter postpartal können darüber hinaus die Laktation beeinflussen.

Hintergrund Mütter von Frühgeborenen, die ihr Kind mit Muttermilch ernähren wollen, stehen vor besonderen Herausforderungen, darunter die Notwendigkeit des Abpumpens in einer häufig psychisch belastenden Situation [1]. Studien mit Müttern von reifen Neugeborenen zeigen, dass der Wunsch das Kind mit Muttermilch zu ernähren zu hohem psychischen Druck führen kann [2]. Dieser wiederrum kann die Milchmenge negativ beeinflussen und erneuten Stress fördern. Inwieweit dieser Druck Mütter Frühgeborener betrifft ist derzeit noch unklar. Außerdem gibt es keine Erkenntnisse über mögliche Ebenen des mütterlichen Drucks, das Kind mit Muttermilch zu ernähren und dessen Interaktion mit der Milchmenge.

The measures taken to contain the COVID-19 pandemic had a major impact on society, affecting medical care as well as the utilization of medical services. We aimed to identify pandemic-related changes in gynaecologic/obstetric care through the personal experience of practitioners in the outpatient sector in Germany. Three consecutive anonymous online surveys of practising gynaecologists were conducted during the pandemic (07–09/2020, 11–12/2020 and 09–11/2021). Appointment management, medical supply and patients’ demand as well as concomitant circumstances were queried. Data from 860 (393, 262 and 205 from the first, second and third surveys, respectively) respondents were analysed. At the peak of the first COVID-19 wave, more than 50% of the gynaecologists surveyed had cancelled cancer screening appointments. There was a significant association between fear of self-infection and cancellation of cancer screening appointments (p = 0.006). An increase in domestic violence was reported by 13%, an increase in obesity by 67% and more advanced tumours due to delayed screening by 24% of respondents. Primary gynaecological oncological prevention was reduced in supply and demand during the COVID-19 pandemic, and this shortfall should be addressed in future similar situations. Prenatal care has been offered continuously since the start of the pandemic in Germany.

Hintergrund Für Frühgeborene, vor allem mit sehr niedrigem Geburtsgewicht ( < 1500g), wird die ausschließliche Ernährung mit Muttermilch empfohlen (WHO 2022). Dieses Ziel wird in der alltäglichen Versorgungspraxis in Deutschland in der Regel noch nicht erreicht. Auch den Ergebnissen einer Mütterbefragung im Rahmen des Projekts Neo-MILK zufolge konnten lediglich 31 % der Mütter (von n=514) ihr Kind ausschließlich mit Muttermilch (MOM= mother‘s own milk) ernähren. Es stellt sich somit die Frage, wie die Potenziale mit Blick auf die Muttermilch (MOM) weiter gestärkt werden können.

Hintergrund Mütter von frühgeborenen Kindern benötigen professionelle Unterstützung und Anleitung, um die Laktation frühzeitig anzuregen [1]. Um diese Unterstützung bei der Laktation sowie Zugang zu Informationen zu ermöglichen, sollte das Personal auf neonatologischen Intensivstationen einheitliche Inhalte vermitteln können. Diese können durch Schulungen zur Still- und Laktationsförderung für die Mitarbeitenden definiert und gefestigt werden. Studien konnten bereits die positiven Effekte einer strukturierten Still- und Laktationsförderung für die Initiierung der Laktation und die Stilldauer zeigen [2] [3]. Unklar ist, in welchem Rahmen die Mitarbeitenden auf neonatologischen Intensivstationen in Deutschland derzeit in der Still- und Laktationsförderung geschult werden.

Background: In Germany, general practitioners (GPs) provide basic and primary care in the ambulatory sector and refer patients to other specialists when necessary. Often, GPs present the first point of contact for patients in the German healthcare system. During the COVID-19 pandemic, GPs and other medical specialists in the ambulatory setting suddenly were confronted with unprecedented challenges. Objective: To answer the following research questions: How did COVID-19-related challenges affect the work climate? Do physicians with deteriorated work climate simultaneously report a worsened provision of patient care? Which challenges were the most burdening? Methods: In the course of the project COVID-GAMS more than 18 000 physicians of various specialties had been invited to a quantitative cross-sectional online survey (in Summer 2020). Analyses were conducted separately for the groups of GPs and other medical specialists. Group differences were analysed statistically and burdening factors were identified. Results: 1703 participants were included in the analysis. 22.2% of GPs (other medical specialists: 19.9%) stated, their work climate had deteriorated. Physicians with a deteriorated work climate showed a tendency towards poorer personal provision of patient care (M = 3.75, SD = 0.98 versus M = 3.93, SD = 0.99) compared to unchanged or improved work climate. The lack of protective material in March/April 2020, changes in practice management and possible economic impacts on the practice were the most burdening factors reported by GPs. Conclusion: GPs who reported a negative impact on the work climate in the course of the first pandemic lockdown also tend to see own deficits in the provision of patient care.

BACKGROUND:In the wake of the coronavirus disease 2019 (COVID-19) pandemic, administrative barriers to the use of telemedicine have been reduced in Germany. The study focused on the analysis of use and assessment of telemedicine by physicians working in the outpatient sector, considering the perspective of different disciplines during the COVID-19 pandemic in Germany.METHODS:The anonymous cross-sectional online survey within the study COVID-GAMS was conducted from 16 November 2020 to 1 January 2021. General practitioners; cardiologists; gastroenterologists; paediatricians; gynaecologists; ear, nose, and throat (ENT) specialists were randomly selected and invited to participate in the survey. At the same time, open recruitment to the online survey was conducted via the professional societies. Descriptive and regression analyses were performed based on the data of 1521 outpatient responding physicians.RESULTS:The use of telephone and video consultation increased during the pandemic. Regarding the frequency of use, physicians already using telephone/video consultations in March/April 2020 report an increase in such services. General medicine was associated with an increased use of telephone and video consultations than cardiology, gynaecology or ENT, and in the case of telephone consultations also compared to paediatrics. General practitioners assessed the subjective usefulness higher than gynaecology and ENT. And the self-reported proportion of patients receiving telemedical care was higher correlated with general medicine than all other disciplines. The location of the practice (rural vs. urban), type of practice (individual vs. group) and gender (male vs. female) were also shown to be significant influencing factors on the variables mentioned above. Barriers reported by physicians not using telemedicine were the lack of equivalence to face-to-face contact and perceived low demand from patients.CONCLUSION:The COVID-19 pandemic has led to a significant increase in the use of telemedicine, to varying degrees in the different specialities. Individual and structural factors lead to a reduced use of telemedicine and there are physician's and patient's barriers that have prevented telephone and video consultations from gaining acceptance by physicians. All these factors must be addressed if telemedicine procedures are to be implemented widely.