Abstract:
BACKGROUND:Most extremely low gestational age neonates (ELGANS, postmenstrual age at birth (PMA) < 28 completed weeks) require supplemental oxygen and experience frequent intermittent hypoxemic and hyperoxemic episodes. Hypoxemic episodes and exposure to inadequately high concentrations of oxygen are associated with an increased risk of retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI), and death beyond 36 weeks PMA. Closed-loop automated control of the inspiratory fraction of oxygen (FiO2-C) reduces time outside the hemoglobin oxygen saturation (SpO2) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload. Effects on clinically important outcomes in ELGANs such as ROP, BPD, NEC, NDI and mortality have not yet been studied. METHODS:An outcome-assessor-blinded, randomized controlled, parallel-group trial was designed and powered to study the effect of FiO2-C (in addition to routine manual control (RMC) of FiO2), compared to RMC only, on death and severe complications related to hypoxemia and/or hyperoxemia. 2340 ELGANS with a GA of 23 + 0/7 to 27 + 6/7 weeks will be recruited in approximately 75 European tertiary care neonatal centers. Study participants are randomly assigned to RMC (control-group) or FiO2-C in addition to RMC (intervention-group). Central randomization is stratified for center, gender and PMA at birth (< 26 weeks and ≥ 26 weeks). FiO2-C is provided by commercially available and CE-marked ventilators with an FiO2-C algorithm intended for use in newborn infants. The primary outcome variable (composite of death, severe ROP, BPD or NEC) is assessed at 36 weeks PMA (or, in case of ROP, until complete vascularization of the retina, respectively). The co-primary outcome variable (composite outcome of death, language/cognitive delay, motor impairment, severe visual impairment or hearing impairment) is assessed at 24 months corrected age. DISCUSSION:Short-term studies on FiO2-C showed improved time ELGANs spent within their assigned SpO2 target range, but effects of FiO2-C on clinical outcomes are yet unknown and will be addressed in the FiO2-C trial. This will ensure an appropriate assessment of safety and efficacy before FiO2-C may be implemented as standard therapy. TRIAL REGISTRATION:The study is registered at www.ClinicalTrials.gov: NCT03168516 , May 30, 2017.
journal_name
BMC Pediatrjournal_title
BMC pediatricsauthors
Maiwald CA,Niemarkt HJ,Poets CF,Urschitz MS,König J,Hummler H,Bassler D,Engel C,Franz AR,FiO2-C Study Group.doi
10.1186/s12887-019-1735-9subject
Has Abstractpub_date
2019-10-21 00:00:00pages
363issue
1issn
1471-2431pii
10.1186/s12887-019-1735-9journal_volume
19pub_type
杂志文章相关文献
BMC Pediatrics文献大全abstract:BACKGROUND:The aim of this study was to revise the 2003 Fenton Preterm Growth Chart, specifically to: a) harmonize the preterm growth chart with the new World Health Organization (WHO) Growth Standard, b) smooth the data between the preterm and WHO estimates, informed by the Preterm Multicentre Growth (PreM Growth) stu...
journal_title:BMC pediatrics
pub_type: 杂志文章,meta分析,评审
doi:10.1186/1471-2431-13-59
更新日期:2013-04-20 00:00:00
abstract:BACKGROUND:At present, there are few studies on the economic burden and medical treatment of children with asthma in China. Thus this study aimed to investigate the economic burden of medical treatment of children with asthma in China. METHOD:The 2015 China Medical Insurance Research Association (CHIRA) database was s...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-020-02268-6
更新日期:2020-08-18 00:00:00
abstract:BACKGROUND:Differences in both Sudden Infant Death Syndrome (SIDS) rates and infant care practices between white British and South Asians in UK are well known, but research has not yet examined how these two groups understand and implement SIDS-reduction guidance. This study aimed to discover how white British and Paki...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-016-0560-7
更新日期:2016-01-30 00:00:00
abstract:BACKGROUND:Acute appendicitis (AA) is the most common surgical condition in children. Although a higher incidence of AA in summer has been reported, the reason for this observation remains unclear. The purpose of this study was to compare the clinical findings of AA patients who underwent appendectomies during the summ...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-019-1824-9
更新日期:2019-11-16 00:00:00
abstract:BACKGROUND:Childhood is an important period for developing maturity in thinking. Accumulating evidence shows the association between physical activity and cognitive function. Although both the intelligence quotient and emotional quotient have been reported to be associated with physical activity, there is a limited amo...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-020-2017-2
更新日期:2020-03-12 00:00:00
abstract:BACKGROUND:Sustained inflations (SI) are advocated for the rapid establishment of FRC after birth in preterm and term infants requiring resuscitation. However, the most appropriate way to deliver a SI is poorly understood. We investigated whether a volume-limited SI improved the establishment of FRC and ventilation hom...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/1471-2431-14-43
更新日期:2014-02-15 00:00:00
abstract:BACKGROUND:Otitis Media (OM) is the most common disease of childhood. Twenty thousand people die each year from otitis media. It is an important cause of preventable hearing loss, affects children's intellectual performance and language development. There are very small numbers of studies done in Ethiopia concerning th...
journal_title:BMC pediatrics
pub_type: 杂志文章,多中心研究
doi:10.1186/s12887-019-1781-3
更新日期:2019-11-01 00:00:00
abstract:BACKGROUND:Stimulation is the most common intervention during neonatal resuscitation at birth, but scarce information is available on the actual methods, timing and efficacy of this basic step. To evaluate the occurrence, patterns and response to tactile stimulation at birth in a low-resource setting. METHODS:We revie...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-018-1279-4
更新日期:2018-09-20 00:00:00
abstract:BACKGROUND:For every newborn who dies within the first month, as many as eight more suffer life-threatening complications but survive (termed 'neonatal near-misses' (NNM)). However, there is no universally agreed-upon definition or assessment tool for NNM. This study sought to describe the development of the Neonatal N...
journal_title:BMC pediatrics
pub_type: 杂志文章,多中心研究
doi:10.1186/s12887-019-1883-y
更新日期:2019-12-23 00:00:00
abstract:BACKGROUND:Adolescents with chronic illness (CI) and parents of a child with CI are at risk for psychosocial problems. Psychosocial group interventions may prevent these problems. With the use of cognitive-behavioral therapy, active coping strategies can be learned. Offering an intervention online eliminates logistic b...
journal_title:BMC pediatrics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1186/s12887-018-1216-6
更新日期:2018-07-18 00:00:00
abstract:BACKGROUND:Rotavirus antigenemia and RNAemia (the presence of rotavirus RNA in serum) have been commonly identified among paediatric patients with acute gastroenteritis. In this study we examined the association between rotavirus antigenemia and clinical features, and sought to determine the genotypes of rotaviruses de...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-019-1535-2
更新日期:2019-06-12 00:00:00
abstract:BACKGROUND:Early diagnosis and treatment are improving significantly the quality of life of patients with cystic fibrosis (CF). This recessive disease is caused by a great variability of mutations in the CF transmembrane conductance (CFTR) gene, whose spectrum and frequency can be different across populations. METHODS...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-019-1903-y
更新日期:2020-01-03 00:00:00
abstract:BACKGROUND:This study determined if the body mass index, dynamic plantar-pressures, plantar surface contact-area, velocity of the centre of pressure (COP), gastrocnemius equinus, and gastrocnemius soleus equines are related to calcaneal apophysitis (Sever's disease) in athletic children. METHODS:This case-control stud...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-018-1318-1
更新日期:2018-11-19 00:00:00
abstract:BACKGROUND:Paracetamol (also known as acetaminophen) is the commonest available analgesic and anti-pyretic. It is readily accessed from pharmacy, patent medicine and provision shops as over the counter drug making it a potential drug of abuse, especially in children. We sought to find its use and/or misuse in children ...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/1471-2431-12-103
更新日期:2012-07-19 00:00:00
abstract:BACKGROUND:Neonatal jaundice is a common finding in newborns in Asia, including Indonesia. In some cases, the serum total bilirubin levels exceeds the 95th percentile for hours of life (neonatal hyperbilirubinemia). Severe neonatal hyperbilirubinemia (NH) could lead to kernicterus and neonatal death. Glucose-6-Phosphag...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-019-1882-z
更新日期:2019-12-20 00:00:00
abstract:BACKGROUND:Some etiological factors involved in developmental dysplasia of the hip (DDH) occur in the last trimester of pregnancy, which could result in a decreased incidence of DDH in preterm infants. The aim of this study was to compare the incidence of DDH between preterm and term infants. METHODS:Ultrasound of the...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-017-0829-5
更新日期:2017-03-16 00:00:00
abstract:BACKGROUND:The use of osteopathic manipulative treatment (OMT) in preterm infants has been documented and results from previous studies suggest the association between OMT and length of stay (LOS) reduction, as well as significant improvements in several clinical outcomes. The aim of the present study is to investigate...
journal_title:BMC pediatrics
pub_type: 杂志文章,随机对照试验
doi:10.1186/1471-2431-13-65
更新日期:2013-04-26 00:00:00
abstract:BACKGROUND:Subacute Sclerosing Panencephalitis (SSPE) is so rare in developed countries with measles immunization programs that national active surveillance is now needed to capture sufficient number of cases for meaningful analysis of data. Through the Canadian Paediatric Surveillance Program (CPSP), the SSPE study wa...
journal_title:BMC pediatrics
pub_type: 杂志文章,评审
doi:10.1186/1471-2431-5-47
更新日期:2005-12-15 00:00:00
abstract:BACKGROUND:The Cystic Fibrosis Questionnaire (CFQ) is widely used in research as an instrument to measure quality of life in patients with cystic fibrosis (CF). In routine patient care however, measuring quality of life is still not implemented in guidelines. One of the reasons might be the lack of consensus on how to ...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/1471-2431-11-86
更新日期:2011-10-11 00:00:00
abstract:BACKGROUND:In biliary atresia, the disease process of obliterative cholangiopathy may begin in the perinatal period; however, no chronological evidence exists on how the cholangiopathy progresses to biliary obliteration. This is the first acquired case with the final diagnosis of type III cystic biliary atresia with an...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-018-1125-8
更新日期:2018-05-11 00:00:00
abstract:BACKGROUND:To compare the outcomes of ultra-fast-track anesthesia (UFTA) and conventional anesthesia in cardiac surgery for children with congenital heart disease (CHD) and low birth weight. METHODS:One hundred and ninety-four CHD children, aged 6 months to 2 years, weighting 5 to 10 kg, were selected for this study. ...
journal_title:BMC pediatrics
pub_type: 杂志文章,随机对照试验
doi:10.1186/s12887-019-1832-9
更新日期:2019-12-11 00:00:00
abstract:BACKGROUND:It is believed that parents have a great influence on their children's dietary behaviours. However, it is not clear whether parental food patterns are associated with children's nutritional status in China, which includes a vast territory with rich, diverse cultures. The goal of this project is to systematic...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-020-1910-z
更新日期:2020-01-11 00:00:00
abstract:BACKGROUND:Rosai- Dorfman Disease (RDD) is a benign condition of unknown aetiology which is characterized by non-neoplastic proliferation of histiocytes. Pathophysiology and natural history remain obscure due to the low prevalence of disease. It is known to present with nodal or extranodal involvement and occurrence in...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-020-02368-3
更新日期:2020-10-08 00:00:00
abstract:BACKGROUND:Mental disorders in childhood have a considerable health and societal impact but the associated negative consequences may be ameliorated through early identification of risk and protective factors that can guide health promoting and preventive interventions. The objective of this study was to inform health p...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/1471-2431-14-166
更新日期:2014-07-01 00:00:00
abstract:BACKGROUND:Secondhand smoke (SHS) exposure of children due to parental tobacco use is a particularly prevalent health issue and is associated with adverse health outcomes. Following the US Clinical Practice guidelines, pediatricians in the United States deliver 5A's (ask, advise, assess, assist, and arrange) counseling...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-016-0672-0
更新日期:2016-08-20 00:00:00
abstract:BACKGROUND:The Cochrane Neonatal Review Group (CNRG) has achieved a lot with limited resources in producing high quality systematic reviews to assist clinicians in evidence-based decision-making. A formal assessment of published CNRG systematic reviews has not been undertaken; we sought to provide a comprehensive asses...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/1471-2431-9-38
更新日期:2009-06-17 00:00:00
abstract:BACKGROUND:Neonatal near miss cases occur more often than neonatal deaths and could enable a more comprehensive analysis of risk factors, short-term outcomes and prognostic factors in neonates born to mothers with severe obstetric complications. The objective was to assess the incidence, presentation and perinatal outc...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-015-0362-3
更新日期:2015-04-17 00:00:00
abstract:BACKGROUND:Childhood vaccinations have been shown to be effective in protecting children against vaccine-preventable diseases. The systematic investigation of the causes of incomplete immunization is critical for the full immunization and develop health system interventions to improve immunization coverage. To date, no...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/s12887-019-1575-7
更新日期:2019-06-14 00:00:00
abstract:BACKGROUND:Infections in newborns remain one of the most significant problems in modern medicine. Escherichia coli is an important cause of neonatal bloodstream and respiratory tract infections and is associated with high mortality. The aim of our study was to investigate the epidemiology of E. coli infection in Polish...
journal_title:BMC pediatrics
pub_type: 杂志文章
doi:10.1186/1471-2431-14-274
更新日期:2014-10-18 00:00:00
abstract:BACKGROUND:Medication administration error is a medication error that occurs while administering a medication to a patient. A variety of factors make pediatrics more susceptible to medication errors and its consequences. In low-income countries, like Ethiopia, there is no sufficient evidence regarding medication admini...
journal_title:BMC pediatrics
pub_type: 杂志文章,多中心研究
doi:10.1186/s12887-018-1294-5
更新日期:2018-10-10 00:00:00