BACKGROUND:Extremely preterm infants require respiratory support with supplemental oxygen and have frequent hypoxaemic episodes. These episodes, and exposure to inadequately high concentrations of oxygen, are associated with major complications and death. Closed-loop automated control of the fractional concentration of oxygen in inspired air (FiO2-C) reduces the time below and above the target range for the pulse oximeter oxygen saturation (SpO2) and caregivers' workload. We aimed to study whether FiO2-C during respiratory support versus routine manual control might also improve clinical outcomes. METHODS:This multicentre, parallel-group, randomised, controlled, superiority trial was done in 32 neonatal intensive care units in China, Germany, the Netherlands, and the UK. Infants born at 23+0 weeks to 27+6 weeks postmenstrual age were included and randomly assigned to FiO2-C or routine manual care stratified within centres by postmenstrual age at birth and sex. FiO2-C was provided in addition to routine manual control of FiO2 using infant ventilators. The composite primary endpoint was death, necrotising enterocolitis, or bronchopulmonary dysplasia up to 36 weeks postmenstrual age, or severe retinopathy of prematurity by 44 weeks postmenstrual age. Secondary endpoints were the components of the primary endpoint and the maximum retinopathy of prematurity severity score in either eye on the International Neonatal Consortium Retinopathy of Prematurity Activity Scale. The trial was stopped early because of poor recruitment. The primary analysis included the intention-to-treat population with non-missing primary outcome data. This trial was registered with ClinicalTrials.gov (NCT03168516) and is closed. FINDINGS:Between July 1, 2018, and Oct 31, 2023, 1082 infants were enrolled and randomly assigned to the FiO2-C group (n=539) or routine manual control group (n=543). Median postmenstrual age was 26+1 weeks (IQR 24+6-27+1). 557 (51%) of 1082 infants were male and 525 (49%) were female. The primary endpoint occurred in 206 (39%) of 534 infants in the FiO2-C group versus 222 (41%) of 538 infants in the routine manual control group (adjusted odds ratio 0·90, 97·5% CI 0·65-1·24; p=0·47). Rates of death (48 [9%] of 536 infants vs 50 [9%] of 541 infants), necrotising enterocolitis (27 [5%] of 538 vs 36 [7%] of 542), bronchopulmonary dysplasia (104 [21%] of 486 vs 110 [23%] of 485), and severe retinopathy of prematurity (86 [18%] of 491 vs 95 [19%] of 496) were also similar between groups. The maximum retinopathy of prematurity severity score was similar between groups (median 7 [IQR 0-9]; p=0·24). Overall, 197 serious adverse events were reported in the FiO2-C group and 192 in the routine manual control group, with no evidence of harm related to the intervention. Postnatal age at death and primary causes of death were similar in both groups. Four serious incidents related to software function without apparent harm to affected infants were reported. INTERPRETATION:FiO2-C did not improve neonatal clinical outcomes. The long-term application of FiO2-C to reduce caregivers' workload might be considered safe. FiO2-C algorithms should be tested before routine application. FUNDING:German Federal Ministry of Education and Research.
Abstract Background The psychosocial stress experienced by families with young children during the pandemic raised concerns about developmental risks, particularly for preterm infants, who are highly sensitive to environmental influences. This study examined the association between parent-reported pandemic burden and cognitive, language and motor development of preterm children. Methods Between 2022 and 2023, a total of 69 children (median corrected age: 21.59 months) were assessed, 62.3% of whom were born prematurely. A subset of these preterm children ( n = 31), restricted to improve age alignment, was compared to a pre-pandemic cohort ( n = 40; median age: 22.2 months). Development was measured using the Bayley Scales of Infant and Toddler Development (Second and Third Edition). The pandemic burden was quantified using the Corona-Index, which was based on a standardised parental questionnaire. Multiple linear regressions were conducted with the Corona-Index as the main predictor and sex, gestational age, socioeconomic status and parental stress as moderators. Group differences were analysed using Mann-Whitney-U-Tests. Results Cognitive and motor scores did not differ significantly between cohorts, whereas language scores were significantly lower in the pandemic group ( p = 0.001). The overall regression models for cognitive and language development did not reach statistical significance, and their sub-analyses should be interpreted with caution. Within the pandemic cohort, a significant interaction between the Corona-Index and sex was found for motor development ( p = 0.022). Exploratory interaction effects suggested possible sex-related differences. Conclusion Overall, preterm children assessed during the pandemic showed differences in language scores compared to the pre-pandemic control group, which may theoretically be linked to altered social environments. However, instrument-related variability and residual clinical confounding cannot be excluded. Exploratory analyses highlighted the importance of examining sex-specific patterns in the context of environmental disruptions.
Nach der Exzision kutaner Tumoren im Stirn- und Wangenbereich entstehen typischerweise rundliche oder ovale Defekte, deren rekonstruktive Versorgung hohe funktionelle und ästhetische Anforderungen erfüllt. In Abhängigkeit von Defektgröße und -tiefe, Lokalisation und Gewebeverschieblichkeit kommen primäre Dehnungsplastiken, verschiedene Lokallappen (Verschiebe‑, Rotations‑, Transpositions- und Insellappen) und – bei größeren Defekten – Spalt- oder Vollhauttransplantationen zum Einsatz. Lokale Verschlussverfahren nutzen farb- und texturidentische Haut und erlauben eine Narbenführung entlang der „relaxed skin tension lines“, wodurch sich spannungsarme Verschlüsse und unauffällige Narbenbilder erzielen lassen. Transplantationsverfahren bieten dagegen eine Option bei ausgedehnten Defekten oder limitierten Lappenmöglichkeiten, sind im Gesichtsbereich jedoch insbesondere hinsichtlich Schrumpfung, Pigmentierung und Oberflächenqualität kritisch zu bewerten. Ein strukturiertes Vorgehen entlang eines rekonstruktiven Stufenplans, eine sorgfältige präoperative Planung und eine atraumatische Nahttechnik sind entscheidend, um funktionelle Einschränkungen zu vermeiden und ein optimales ästhetisches Ergebnis sicherzustellen.
