Clinical aspects of umbilical cord cannulation during transfer from the uterus to a liquid-based perinatal life support system for extremely premature infants:A qualitative generic study

A liquid-based perinatal life support system (PLS) for extremely premature infants (born before 28 week of gestational age) envisions a connection between the infant’s native umbilical cord and an artificial placenta system through cannulation. This system mimics a natural mothers’ womb to achieve better organ maturations. The objective of this study is to gain insight into the clinical focus points of umbilical cord cannulation and how cannulation should be addressed in extremely premature infants during the transfer from the uterus to an in-utero simulating liquid-based PLS system. We performed an explorative qualitative study. Twelve medical specialists with knowledge of vessel cannulation participated. We collected data through twelve interviews and two focus group discussions. Data were analyzed using inductive content and constant comparison analysis via open and axial coding. Results were derived on the following topics: (1) cannulation technique, (2) cannula fixation, (3) local and systemic anticoagulation, and (4) vasospasm. A side-entry technique is preferred as this may decrease wall damage, stabilizes the vessel better and ensures continuous blood flow. Sutures, especially via an automatic microsurgery instrument, are favored above glue, stents, or balloons as these may be firmer and faster. Medication possibilities for both vasospasm and anticoagulation should function locally since there were uncertainties regarding the systemic effects. According to the findings of this research, the needed umbilical cord cannulation method should include minimal wall damage, improved vascular stability, blood flow maintenance, a strong fixation connection, and local anticoagulation effect

Clinical aspects of umbilical cord cannulation during transfer from the uterus to a liquid-based perinatal life support system for extremely premature infants:A qualitative generic study

A liquid-based perinatal life support system (PLS) for extremely premature infants (born before 28 week of gestational age) envisions a connection between the infant’s native umbilical cord and an artificial placenta system through cannulation. This system mimics a natural mothers’ womb to achieve better organ maturations. The objective of this study is to gain insight into the clinical focus points of umbilical cord cannulation and how cannulation should be addressed in extremely premature infants during the transfer from the uterus to an in-utero simulating liquid-based PLS system. We performed an explorative qualitative study. Twelve medical specialists with knowledge of vessel cannulation participated. We collected data through twelve interviews and two focus group discussions. Data were analyzed using inductive content and constant comparison analysis via open and axial coding. Results were derived on the following topics: (1) cannulation technique, (2) cannula fixation, (3) local and systemic anticoagulation, and (4) vasospasm. A side-entry technique is preferred as this may decrease wall damage, stabilizes the vessel better and ensures continuous blood flow. Sutures, especially via an automatic microsurgery instrument, are favored above glue, stents, or balloons as these may be firmer and faster. Medication possibilities for both vasospasm and anticoagulation should function locally since there were uncertainties regarding the systemic effects. According to the findings of this research, the needed umbilical cord cannulation method should include minimal wall damage, improved vascular stability, blood flow maintenance, a strong fixation connection, and local anticoagulation effect

Transfer Of A Preterm Baby From A Natural Womb

The present invention relates to a transfer assembly for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag. The present invention further relates to a kit-of-parts for assembling a transfer assembly. Also the present invention relates to a transfer device and/or a birth canal retractor for use in a transfer assembly of the present invention. An alternative transfer device is provided as well. Further, the present invention relates to a method for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag

Simulation-based development: shaping clinical procedures for extra-uterine life support technology

Background Research into Artificial Placenta and Artifcial Womb (APAW) technology for extremely premature infants (born < 28 weeks of gestation) is currently being conducted in animal studies and shows promising results. Because of the unprecedented nature of a potential treatment and the high-risk and low incidence of occurrence, translation to the human condition is a complex task. Consequently, the obstetric procedure, the act of transferring the infant from the pregnant woman to the APAW system, has not yet been established for human patients. The use of simulation-based user-centered development allows for a safe environment in which protocols and devices can be conceptualized and tested. Our aim is to use participatory design principles in a simulation context, to gain and inte‑ grate the user perspectives in the early design phase of a protocol for this novel procedure.Methods Simulation protocols and prototypes were developed using an iterative participatory design approach; usability testing, including general and task specifc feedback, was obtained from participants with clinical expertise from a range of disciplines. The procedure made use of fetal and maternal manikins and included animations and protocol task cards.Results Physical simulation with the active participation of clinicians led to the difusion of tacit knowledge and an iteratively formed shared understanding of the requirements and values that needed to be implemented in the procedure. At each sequel, participant input was translated into simulation protocols and design adjustments.Conclusion This work demonstrates that simulation-based participatory design can aid in shaping the future of clinical procedure and product development and rehearsing future implementation with healthcare professional

Simulation-based development: shaping clinical procedures for extra-uterine life support technology

Background Research into Artificial Placenta and Artifcial Womb (APAW) technology for extremely premature infants (born < 28 weeks of gestation) is currently being conducted in animal studies and shows promising results. Because of the unprecedented nature of a potential treatment and the high-risk and low incidence of occurrence, translation to the human condition is a complex task. Consequently, the obstetric procedure, the act of transferring the infant from the pregnant woman to the APAW system, has not yet been established for human patients. The use of simulation-based user-centered development allows for a safe environment in which protocols and devices can be conceptualized and tested. Our aim is to use participatory design principles in a simulation context, to gain and inte‑ grate the user perspectives in the early design phase of a protocol for this novel procedure.Methods Simulation protocols and prototypes were developed using an iterative participatory design approach; usability testing, including general and task specifc feedback, was obtained from participants with clinical expertise from a range of disciplines. The procedure made use of fetal and maternal manikins and included animations and protocol task cards.Results Physical simulation with the active participation of clinicians led to the difusion of tacit knowledge and an iteratively formed shared understanding of the requirements and values that needed to be implemented in the procedure. At each sequel, participant input was translated into simulation protocols and design adjustments.Conclusion This work demonstrates that simulation-based participatory design can aid in shaping the future of clinical procedure and product development and rehearsing future implementation with healthcare professional

Right ventricular dysfunction identified by abnormal strain values precedes evident growth restriction in small for gestational age fetuses

Objectives Small for gestational age (SGA) fetuses have an increased risk for adverse outcome. Placental insufficiency leads to changes in the circulation, with secondary adaptation of the fetal heart resulting in changed cardiac deformation. This deformation can be measured with 2D speckle tracking echocardiography (2D‐STE). SGA is antenatally often undiagnosed. The measurement of deformation changes in the fetal heart might help in the prediction of SGA and identify fetuses in need of more intensive surveillance. Methods In this longitudinal prospective cohort study, global longitudinal strain (GLS) and strain rate (GLSR), measured before 23 weeks gestational age were compared between SGA and appropriate for gestational age (AGA) fetuses, based on birthweight corrected for gestational age at birth. Results The fetal heart rate was significantly increased in SGA; 158 beats per minute (146‐163) versus 148 (134‐156); p=0.035 in AGA. Right ventricle GLS (RV‐GLS) values were significantly increased in SGA; ‐15.87% (‐11.69% to ‐20.55%) versus ‐20.24% (‐16.29% to ‐24.28%); p=0.024, respectively. Conclusion RV‐GLS values, measured with 2D‐STE, were significantly increased in SGA, indicating systolic RV dysfunction before 23 weeks gestational age in fetuses who will become SGA later in pregnancy. A large longitudinal prospective cohort study is needed to confirm these findings

Towards A Premature Fetal Manikin For Model-driven Simulation To Validate Perinatal Life Support Technologies

Background and Aims Perinatal-Life-Support (PLS) research is progressing to provide extreme premature infants a safe extracorporeal environment for further growth. A crucial step before being accepted into healthcare is the careful validation of life-support technology. However, clinical trials with living subjects yields great ethical concerns and limits testing and training of early-stage concepts. A promising alternative can be found in manikins, which can resemble infants on an anatomical and even physiological level. Methods An analysis was performed defining the design framework for the manikin to function as a validation model for PLS-technologies. A scientific literature review was conducted to identify parameters involved in the physiologic events that need to be prevented when transferring a perinate into a PLS-system, avoiding neonatal transition and maintaining fetal status. Results In our proposed framework, output of embedded sensors is compared to parameter threshold values as set in a linked computational model. The manikin’s embedded actuators could display symptoms, serving as a feedback loop during testing and training. The parameters include temperature, lung aeration, liquid clearance of lungs, umbilical cord compression, heart rate, blood pressure and flow. Symptoms include chest expansion, gasp reflex, cyanosis, vasospasm, and decreased fetal movement. Lastly, based on MRI scans, a 3D manikin prototype was developed that contains space for hardware integration. Conclusions The development of a simulation to validate a life-support system, not yet tested on humans, is unprecedented. With the proposed framework and requirements, we expect improved feedback during dimensional testing and training, allowing for design improvements and eventually promote success of future clinical trials

Transfer Of A Preterm Baby From A Natural Womb

The present invention relates to a transfer assembly for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag. The present invention further relates to a kit-of-parts for assembling a transfer assembly. Also the present invention relates to a transfer device and/or a birth canal retractor for use in a transfer assembly of the present invention. An alternative transfer device is provided as well. Further, the present invention relates to a method for transferring a preterm baby from a natural womb of a pregnant mammal to a transfer bag