No abstract

Background An intact umbilical cord allows the physiological transfusion of blood from the placenta to the neonate, which reduces infant iron deficiency and is associated with improved development during early childhood. The implementation of delayed cord clamping practice varies depending on mode of delivery, as well as gestational age and neonatal compromise. Emerging evidence shows that infants requiring resuscitation would benefit if respiratory support were provided with the umbilical cord intact. Common barriers to providing intact cord resuscitation is the availability of neonatal resuscitation equipment close to the mother, organizational readiness for change as well as attitudes and beliefs about placental transfusion within the multidisciplinary team. Hence, clinical evaluations of cord clamping practice should include implementation outcomes in order to develop strategies for optimal cord management practice. Methods The Sustained cord circulation And Ventilation (SAVE) study is a hybrid type I randomized controlled study combining the evaluation of clinical outcomes with implementation and health service outcomes. In phase I of the study, a method for providing in-bed intact cord resuscitation was developed, in phase II of the study the intervention was adapted to be used in multiple settings. In phase III of the study, a full-scale multicenter study will be initiated with concurrent evaluation of clinical, implementation and health service outcomes. Clinical data on neonatal outcomes will be recorded at the labor and neonatal units. Implementation outcomes will be collected from electronic surveys sent to parents as well as staff and managers within the birth and neonatal units. Descriptive and comparative statistics and regression modelling will be used for analysis. Quantitative data will be supplemented by qualitative methods using a thematic analysis with an inductive approach. Discussion The SAVE study enables the safe development and evaluation of a method for intact cord resuscitation in a multicenter trial. The study identifies barriers and facilitators for intact cord resuscitation. The knowledge provided from the study will be of benefit for the development of cord clamping practice in different challenging clinical settings and provide evidence for development of clinical guidelines regarding optimal cord clamping. Trial registration Clinicaltrials.gov, NCT04070560. Registered 28 August 2019.

Background: Deferring cord clamping has proven benefits for both term and preterm infants, and recent studies have demonstrated better cardio-respiratory stability if clamping is based on the infant's physiology, and whether the infant has breathed. Nevertheless, current guidelines for neonatal resuscitation still recommend early cord clamping (ECC) for compromised babies, unless equipment and competent personnel to resuscitate the baby are available at the mother's bedside. The objective of this quality improvement cohort study was to evaluate whether implementing a new delivery room protocol involving mobile resuscitation equipment (LifeStart™) reduced the prevalence of ECC in assisted vaginal deliveries. Methods: Data on cord clamping and transitional care were collected 8 months before and 8 months after implementing the new protocol. The Model for Improvement was applied to identify drivers and obstacles to practice change. Statistical Process Control analysis was used to demonstrate signals of improvement, and whether these changes were sustainable. Multivariate logistic regression was used to evaluate the impact of the new protocol on the primary outcome, adjusted for possible confounders. Results: Overall prevalence of ECC dropped from 13 to 1% (P < 0.01), with a 98% relative risk reduction for infants needing transitional support on a resuscitation table (adjusted OR 0.02, P < 0.001). Mean cord clamping time increased by 43% (p < 0.001). Although fewer infants were placed directly on mothers' chest (n = 43 [42%] vs n = 69 [75.0%], P < 0.001), there were no significant differences in needs for immediate transitional care or transfers to Neonatal Intensive Care Unit. A pattern of improvement was seen already before the intervention, especially after mandatory educational sessions and cross-professional simulation training. Conclusions: A new delivery-room protocol involving mobile resuscitation equipment successfully eliminated early cord clamping in assisted vaginal deliveries of term and near-term infants. A systematic approach, like the Model for Improvement, seemed crucial for both achieving and sustaining the desired results.

Re: Fosterdiagnostikk med blodprøver692Flere tester for det samme, og mer til?Kjell Åsmund Salvesen advarer i sin kommentar mot å rope ulv ved innføringen av non-invasiv prenatal testing (NIPT) og konkluderer med at NIPT ikke erstatter ultralyd, men at det kan vaere et egnet supplement (1). Innspillet til Salvesen minner om ultralydlegen som klaget på at hans ultralydapparat var gammelt, ubrukelig og farlig. Etter mye mas fikk han ett nytt apparat, men det gamle ble ikke kassert. Det ble satt på bakrommet som reserve. Det gikk ikke lenge før det var i fullt bruk igjen, og etter noen år skulle begge apparater erstattes -de var gamle, ubrukelige og farlige. Ultralydlegen kunne sitt rop om ulv.Denne gangen er det motsatt. Salvesen mener at det å problematisere NIPT er å rope ulv unødig. En dårlig metode -kombinert ultralyd og blodprøve (KUB) -skal suppleres med en ny og bedre. Enkelt og greit.I en studie, hvor Salvesen var medforfatter, fant man at langt under halvparten av legene forholder seg til kriteriene i bioteknologiloven for KUB (2). Det å vurdere at en metode også kan komme til å brukes utenfor det den opprinnelig ble tiltenkt, burde derfor ikke vaere fremmed for Salvesen.Allerede nå arbeider man intenst med å utvide antall tilstander man kan teste med non-invasiv prenatal diagnostikk (NIPD), og prisene vil ganske sikkert synke, slik Salvesen spår. Det er vanskelig å se hvorfor NIPD hovedsakelig skulle brukes til å oppdage trisomier. Hva er det med disse, og med Downs syndrom spesielt, som gjør at det er verdt å bruke minst 390 000 norske kroner på hvert ekstra tilfelle som oppdages (3)? Og hvorfor skulle vi ikke samtidig kunne undersøke en lang rekke andre tilstander?Salvesen sier videre: «Spørsmålet om hvordan vi skal håndtere informasjon fra helgenomsekvensering gjelder ikke bare i fosterlivet, men også for barn og voksne i alle aldre.» (1) Det er derfor ingen grunn til å rope ulv. Her kan det synes som om fostermedisineren ikke ser forskjell på et foster og et født menneske. I det første tilfellet vil informasjonen brukes til å bestemme eksistens eller ikke. I det siste vil det normalt ikke vaere slik. Ser man ikke forskjellen, vil man kunne hevde at personer med visse genetiske egenskaper bør avlives.