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  • BMJ  (3)
  • Zemlin, Michael  (3)
  • 1
    In: Archives of Disease in Childhood - Fetal and Neonatal Edition, BMJ, Vol. 105, No. 2 ( 2020-03), p. 190-195
    Kurzfassung: To determine if survival rates of preterm infants receiving active perinatal care improve over time. Design The German Neonatal Network is a cohort study of preterm infants with birth weight 〈 1500 g. All eligible infants receiving active perinatal care are registered. We analysed data of patients discharged between 2011 and 2016. Setting 43 German level III neonatal intensive care units (NICUs). Patients 8222 preterm infants with a gestational age between 22/0 and 28/6 weeks who received active perinatal care. Interventions Participating NICUs were grouped according to their specific survival rate from 2011 to 2013 to high (percentile 〉 P75), intermediate (P25–P75) and low ( 〈 P25) survival. We compared these survival rates with data in 2014–2016. Main outcome measures Death by any cause before discharge. Results Total survival increased from 85.8% in 2011–2013 to 87.4% in 2014–2016. This increase was due to reduced mortality of NICUs with low survival rates in 2011–2013. Survival increased in these centres from 53% to 64% in the 22–24 weeks strata and from 73% to 84% in the 25–26 weeks strata. Conclusions Our data support previous reports that active perinatal care of very immature infants improves outcomes at the border of viability and survival rates at higher gestational ages. The high total number of surviving infants below 24 weeks of gestation challenges national recommendations exclusively referring to gestational age as the single criterion for providing active care. However, more data are needed before recommendations for parental counselling should be reconsidered. Trial registration Approval by the local institutional review board for research in human subjects of the University of Lübeck (file number 08–022) and by the local ethic committees of all participating centres has been given.
    Materialart: Online-Ressource
    ISSN: 1359-2998 , 1468-2052
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2020
    ZDB Id: 2188490-0
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 2
    In: Archives of Disease in Childhood - Fetal and Neonatal Edition, BMJ, Vol. 108, No. 5 ( 2023-09), p. 492-498
    Kurzfassung: To investigate whether extrauterine growth restriction (EUGR) during the neonatal hospitalisation by sex among extremely preterm (EPT) infants is associated with cerebral palsy (CP) and cognitive and motor abilities at 5 years of age. Study design Population-based cohort of births 〈 28 weeks of gestation with data from obstetric and neonatal records and parental questionnaires and clinical assessments at 5 years of age. Setting 11 European countries. Patients 957 EPT infants born in 2011–2012. Main outcomes EUGR at discharge from the neonatal unit was defined as (1) the difference between Z-scores at birth and discharge with 〈 −2 SD as severe, −2 to −1 SD as moderate using Fenton’s growth charts (Fenton) and (2) average weight-gain velocity using Patel’s formula in grams (g) per kilogram per day (Patel) with 〈 11.2 g (first quartile) as severe, 11.2–12.5 g (median) as moderate. Five-year outcomes were: a CP diagnosis, intelligence quotient (IQ) using the Wechsler Preschool and Primary Scales of Intelligence tests and motor function using the Movement Assessment Battery for Children, second edition. Results 40.1% and 33.9% children were classified as having moderate and severe EUGR, respectively, by Fenton and 23.8% and 26.3% by Patel. Among children without CP, those with severe EUGR had lower IQ than children without EUGR (−3.9 points, 95% Confidence Interval (CI)=−7.2 to −0.6 for Fenton and −5.0 points, 95% CI=−8.2 to −1.8 for Patel), with no interaction by sex. No significant associations were observed between motor function and CP. Conclusions Severe EUGR among EPT infants was associated with decreased IQ at 5 years of age.
    Materialart: Online-Ressource
    ISSN: 1359-2998 , 1468-2052
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2023
    ZDB Id: 2188490-0
    Standort Signatur Einschränkungen Verfügbarkeit
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  • 3
    In: BMJ Open, BMJ, Vol. 9, No. 11 ( 2019-11), p. e032617-
    Kurzfassung: The healthy ‘eubiosis’ microbiome in infancy is regarded as the microbiome derived from term, vaginally delivered, antibiotic free, breastfed infants at 4–6 months. Dysbiosis is regarded as a deviation from a healthy state with reduced microbial diversity and deficient capacity to control drug-resistant organisms. Preterm infants are highly sensitive to early gut dysbiosis. Latter has been associated with sepsis and necrotising enterocolitis, but may also contribute to long-term health problems. Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution. Methods and analysis A randomised, double blind, placebo-controlled study has been designed to assess the safety and efficacy of the probiotic mix of Bifidobacterium longum and infantis and Lactobacillus acidophilus in the prevention of gut dysbiosis in preterm infants between 28+0 and 32+6 weeks of gestation. The study is conducted in 18 German neonatal intensive care units. Between April 2018 and March 2020, 654 preterm infants of 28+0–32+6 weeks of gestation will be randomised in the first 48 hours of life to 28 days of once daily treatment with either probiotics or placebo. The efficacy endpoint is the prevention of gut dysbiosis at day 30 of life. A compound definition of gut dysbosis is used: (1) colonisation with multidrug-resistant organisms or gram-negative bacteria with high epidemic potential or (2) a significant deviation of the gut microbiota composition as compared with healthy term infants. Dysbiosis is determined by (1) conventional microbiological culture and (2) phylogenetic microbiome analysis by high-throughput 16S rRNA and metagenome sequencing. Persistence of dysbiosis will be assessed at 12-month follow-up visits. Side effects and adverse events related to the intervention will be recorded. Key secondary endpoint(s) are putative consequences of dysbiosis. A subgroup of infants will be thoroughly phenotyped for immune parameters using chipcytometry. Ethics and dissemination Ethics approval was obtained in all participating sites. Results of the trial will be published in peer-review journals, at scientific meetings, on the website ( www.primal-study.de ) and via social media of parent organisations. Trial registration number DRKS00013197; Pre-results.
    Materialart: Online-Ressource
    ISSN: 2044-6055 , 2044-6055
    Sprache: Englisch
    Verlag: BMJ
    Publikationsdatum: 2019
    ZDB Id: 2599832-8
    Standort Signatur Einschränkungen Verfügbarkeit
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