paediatrics

儿科
  • 文章类型: Journal Article
    背景:儿童有权参与影响其生活的事务。随着规律性的增加,儿童的观点正在寻求关于他们的健康和医疗保健经验。尽管有证据表明儿童认为玩耍是住院的“最佳”方面之一,研究很少关注儿童在医院玩耍的角度。
    方法:这项定性研究探讨了儿童在住院期间的游戏体验。五个多月,在儿科肿瘤病房进行了人种学观察,并采访了16名3-13岁的儿童。
    结果:使用解释现象学分析,儿童的表情和体验阐明了三个关键点:安全和舒适是儿童在医院中能够玩耍的不可或缺的部分;游戏的价值和功效由儿童决定;游戏是患者首先成为(并被视为)儿童的方式。
    结论:只有当孩子们觉得他们友好时,医院才能对儿童友好。在围绕医院玩耍的重要性的话语中倾听和整合儿童的观点对于尊重儿童的权利和提供以人为本的儿科医疗保健至关重要。
    BACKGROUND: Children have a right to participate in matters affecting their lives. With increasing regularity, children\'s perspectives are being sought regarding their health and health care experiences. Though there is evidence that children find play to be one of the \'best\' aspects of hospitalisation, studies rarely focus on children\'s perspectives on play in hospital.
    METHODS: This qualitative study explored children\'s lived experiences of play during hospitalisation. Over five months, ethnographic observations were conducted on a paediatric oncology ward as well as interviews with 16 children ages 3-13 years.
    RESULTS: Using interpretative phenomenological analysis, children\'s expressions and experiences illuminated three key points: safety and comfort are integral to children feeling able to play in hospital; the value and efficacy of play is decided by children; and that play is a way for patients to be (and be treated as) children first.
    CONCLUSIONS: Hospitals can only be child-friendly if children find them friendly. Listening to and integrating children\'s perspectives in the discourse around the importance of play in hospital is essential for respecting children\'s rights and delivering person-centred paediatric healthcare.
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  • 文章类型: Journal Article
    目的:头孢哌酮是治疗儿童细菌性脑膜炎和脓毒症的常用标志外药物,和药代动力学(PK)的数据是有限的,在这个脆弱的人群。这项研究的目的是开发基于生理的药代动力学(PBPK)模型,以预测儿科头孢哌酮暴露,以推荐合理的剂量。
    方法:首先使用SimcypV22模拟器构建成人头孢哌酮PBPK模型。随后,该模型基于内置的年龄相关生理参数扩展到儿童,而药物特性保持不变。然后使用验证的儿科PBPK模型来评估不同年龄组儿童的常见给药方案的合理性。
    结果:头孢哌酮PBPK模型包括通过胆汁排泄消除,肾小球滤过,和有机阴离子转运蛋白3(OAT3)介导的肾小管分泌。成人中观察到的95.2%的平均浓度以及血浆药物浓度-时间曲线(AUC)和峰值浓度(Cmax)下的面积的100%在模型平均预测的两倍范围内。在儿童中也观察到良好的预测准确性,包括新生儿。当MIC≤1mg/L时,50mg/kgq12h头孢哌酮在虚拟足月新生儿(<1个月)中显示出有效的目标实现,坚持75%fT>MIC的严格PK/PD目标。37.5mg/kgq12h头孢哌酮达到MIC≤0的常见50%fT>MIC目标。在1个月至18岁的虚拟儿科患者中25mg/L。
    结论:为头孢哌酮开发了一种儿科PBPK模型,它可以作为得出儿童合理给药方案的基础。
    OBJECTIVE: Cefoperazone is commonly used off-label in the treatment of bacterial meningitis and sepsis in children, and the pharmacokinetic (PK) data are limited in this vulnerable population. The goal of this study was to develop a physiologically based pharmacokinetic (PBPK) model to predict pediatric cefoperazone exposure for rational dosing recommendations.
    METHODS: A cefoperazone PBPK model for adults was first constructed using Simcyp V22 simulator. Subsequently, the model was extended to children based on the built in age-dependent physiological parameters, while the drug characteristics remained unchanged. The verified pediatric PBPK model was then utilized to assess the rationality of the common dosing regimens for children at different age groups.
    RESULTS: Cefoperazone PBPK model included elimination via biliary excretion, glomerular filtration, and organic anion transporter 3 (OAT3)-mediated tubular secretion. 95.2% of the observed mean concentrations and 100% of the area under the plasma drug concentration-time curve (AUC) and peak concentration (Cmax) in adults were within a twofold range of model mean predictions. Good predictive accuracy was also observed in children, including neonates. 50 mg/kg q12h cefoperazone demonstrated effective target attainment in virtual term neonates (<1 month) when the MIC was ≤1 mg/L, adhering to the stringent PK/PD target of 75% fT > MIC. 37.5 mg/kg q12h cefoperazone achieved the common 50% fT > MIC target for an MIC ≤ 0. 25 mg/L in virtual pediatric patients ranging from 1 month to 18 years of age.
    CONCLUSIONS: A pediatric PBPK model was developed for cefoperazone, and it could serve as the basis for deriving rational dosing regimens in children.
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  • 文章类型: Journal Article
    为了确定临床表现,在我们的背景下,腺样体肥大儿童的影像学特征和结局。
    一项回顾性研究。
    埃努古一家私立医院的儿科诊所。
    51个孩子,2至108个月,具有暗示的临床特征和表现超过3年的腺样体肥大的影像学报告。
    从患者的病历中获得临床信息。数据分析了患者的临床特征,鼻后间隙(PNS)X线片上气道狭窄程度与治疗结果之间的关系。
    在PNS射线照片上测量的气道狭窄程度,治疗的类型和结果。
    腺样体肥大的发生率为男性(54.7%):女性(45.1%),平均发病年龄为31.50±3.64个月。嘈杂的呼吸是最常见的症状(94.1%);64.7%的病例中有过敏性鼻炎病史,45.1%的病例中有超过50%的气道狭窄病例仅通过医疗管理解决。
    在评估五岁以下儿童的上呼吸道时,应考虑腺样体肥大。儿科医生应熟悉诊断和管理上呼吸道阻塞的常见原因。
    没有声明。
    UNASSIGNED: To determine the clinical presentation, imaging features and outcomes of children with adenoid hypertrophy in our setting.
    UNASSIGNED: A retrospective study.
    UNASSIGNED: The paediatric clinic of a private hospital in Enugu.
    UNASSIGNED: 51 children, aged 2 to 108 months, with suggestive clinical features and radiographic report of adenoid hypertrophy who presented over 3 years.
    UNASSIGNED: Clinical information was obtained from the patient\'s medical records. Data was analysed for the clinical characteristics of the patients, the relationship between the degree of airway narrowing on a postnasal space (PNS) radiograph and treatment outcomes.
    UNASSIGNED: Degree of airway narrowing as measured on a PNS radiograph, the type of and outcomes of treatment.
    UNASSIGNED: There was an almost equal male (54.7%): female (45.1%) ratio in the occurrence of adenoid hypertrophy, with a mean age of occurrence of 31.50 ± 3.64 months. Noisy breathing was the commonest symptom (94.1%); history of atopic rhinitis in 64.7% of cases and hyperactive airway disease in 45.1% more than 50% of cases with airway narrowing resolved with medical management only.
    UNASSIGNED: Adenoid hypertrophy should be considered in evaluating the upper airway in children under five. Paediatricians should be conversant with diagnosing and managing this common cause of upper airway obstruction.
    UNASSIGNED: None declared.
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  • 文章类型: Journal Article
    高达75%的儿科患者在接受新的医疗程序之前会经历焦虑和痛苦。虚拟现实是缓解儿科患者的压力和恐惧的一个有趣的途径,因为它能够使孩子完全沉浸在虚拟世界中,从而在接受检查之前将他们暴露在MRI的视野和声音中。我们旨在探讨虚拟现实暴露对减少计划接受MRI的儿科患者的恐惧和焦虑的影响。我们假设在MRI之前接受VR暴露的患者会经历较低水平的恐惧和焦虑,随后具有较高的MRI成功率。我们在一家三级儿科医院进行了为期三周的前瞻性随机对照试验。纳入标准包括4至14岁接受MRI的儿童,没有使用VR的医学禁忌症。30例患者(VR中16例,对照中的14个)被包括在研究中。VR房间,由研究人员在内部创建,VR团队经历过的,模拟MRI室与典型的声音长达5分钟之前,他们的实际MRI。对照组在MRI前后以及VR暴露后使用FACES量表测量恐惧和焦虑。关于即将进行的MRI,VR组表现出VR暴露后焦虑的显着降低(p=0.009)。在MRI检查之前或之后,VR组和对照组之间在恐惧和焦虑方面没有显着差异。MRI检查成功率差异无统计学意义。VR暴露有效地减少了即将接受检查的儿科患者的MRI前焦虑,这很重要,因为它减轻了孩子的心理负担。这项研究与以前的发现一致,显示VR作为一种减少术前儿科焦虑的方法的有效性,并表明复杂的VR体验可能不需要产生重大影响。有,然而,需要在这一领域进行进一步研究,使用更大的MRI初治患者组。
    Up to 75% of paediatric patients experience anxiety and distress before undergoing new medical procedures. Virtual reality is an interesting avenue for alleviating the stress and fear of paediatric patients due to its ability to completely immerse the child in the virtual world and thus expose them to the sights and sounds of an MRI before undergoing the exam. We aimed to explore the impact of virtual reality exposure on reducing fear and anxiety in paediatric patients scheduled to undergo an MRI. We hypothesised that patient who had undergone VR exposure before the MRI would experience lower levels of fear and anxiety and subsequently have a higher MRI success rate. We conducted a prospective randomized control trial in a tertiary paediatric hospital over three weeks. Inclusion criteria comprised children aged 4 to 14 undergoing MRI without medical contraindications for VR use. Thirty patients (16 in VR, 14 in control) were included in the study. The VR room, created in-house by a researcher, that the VR group experienced, simulated MRI room with typical sounds for up to 5 min before their actual MRI. Fear and anxiety were measured using the FACES scale before and after MRI for the control group as well as after VR exposure for the VR group. The VR group exhibited a significant reduction in anxiety post-VR exposure regarding the upcoming MRI (p = 0.009). There was no significant difference with regards to fear and anxiety between the VR and control groups before or after the MRI exam. There was no significant difference between the MRI exam success rates. VR exposure effectively reduces pre-MRI anxiety in paediatric patients who are about to undergo the exam, this is important as it alleviates the psychological burden on the child. This research is in line with previous findings, showing the validity of VR as a method of reducing pre-procedural paediatric anxiety and suggesting that complex VR experiences may not be necessary to have a significant impact. There is, however, a need for further investigation in this field using larger and MRI-naïve groups of patients.
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  • DOI:
    文章类型: Journal Article
    UNASSIGNED: Acute agitation in pediatrics is commonly encountered in hospital settings, can contribute to significant physical and psychological distress, and management is highly varied in practice. As such, the development of a standardized pharmacologic guideline is paramount. We aimed to develop a novel clinical pathway (CP) for management of acute agitation for all hospitalized pediatric patients in Canada.
    UNASSIGNED: Healthcare professionals in Canada with expertise in treating and managing pediatric agitation formed a working group and developed a CP through conducting a literature review, engaging key partners, and obtaining interdisciplinary consensus (iterative real-time discussions with content experts). Once developed, the preliminary CP was presented to additional internal and external partners via multiple grand rounds and a webinar; feedback from participants guided final CP revisions.
    UNASSIGNED: The working group created a pediatric inpatient CP to guide pharmacologic management of agitation and serve as an easy-to-use clinical and educational resource with three complementary sections including: 1) a treatment algorithm, 2) a quick reference medication chart, and 3) two supporting documents, which provide a general overview of non-pharmacologic strategies prior to CP implementation and an illustrative scenario to accompany the medication chart to ensure effective utilization.
    UNASSIGNED: This is the first CP to standardize pharmacological treatment and management of acute agitation in children in inpatient settings in Canada. Although further research is warranted to assess implementation and support process improvement, the CP can be adapted by individual institutions to assist in prompt pharmacological management of pediatric agitation to potentially improve outcomes for patients, families, and healthcare professionals.
    UNASSIGNED: L’agitation aiguë en pédiatrie survient couramment en milieu hospitalier, elle peut contribuer à une détresse physique et psychologique significative, et la prise en charge en est très variée dans la pratique. Ainsi, l’élaboration de lignes directrices pharmacologiques standardisées est essentielle. Nous cherchions à développer un nouveau parcours clinique (PC) de la prise en charge de l’agitation aiguë pour tous les patients pédiatriques hospitalisés au Canada.
    UNASSIGNED: Les professionnels de la santé au Canada qui ont l’expertise du traitement et de la prise en charge de l’agitation pédiatrique ont formé un groupe de travail et développé un PC en menant une revue littéraire, en embauchant des partenaires cibles, et en obtenant un consensus interdisciplinaire (discussions itératives en temps réel avec des experts en contenu). Une fois développé, le PC préliminaire a été présenté à des partenaires internes et externes additionnels lors de multiples grandes rondes et à un webinaire; les commentaires des participants ont guidé les révisions finales du PC.
    UNASSIGNED: Le groupe de travail a créé un PC pour patient psychiatrique hospitalisé afin de guider la prise en charge pharmacologique de l’agitation et de servir de ressource clinique et éducative facile à utiliser munie de trois sections complémentaires notamment : 1) un algorithme de traitement, 2) un tableau des médicaments de référence, et 3) deux documents de soutien, qui offrent un aperçu général de stratégies non-pharmacologiques avant la mise en œuvre du PC et un scénario illustré pour accompagner le tableau des médicaments afin d’assurer une utilisation efficace.
    UNASSIGNED: C’est le premier PC qui normalise le traitement pharmacologique et la prise en charge de l’agitation aiguë chez les enfants en milieu hospitalier au Canada. Bien que plus de recherche soit justifiée afin d’évaluer la mise en œuvre et de soutenir l’amélioration du processus, le PC peut être adapté par les institutions individuelles afin d’aider à une gestion pharmacologique rapide de l’agitation pédiatrique et de potentiellement aider à la gestion pharmacologique de l’agitation pédiatrique pour les patients, les familles et les professionnels de la santé.
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  • 文章类型: Journal Article
    背景:估计运动协调问题会影响5%-6%的学龄儿童。运动协调问题对儿童的生活有不同的影响,步态和平衡经常受到影响。纹理鞋垫已显示出对患有与疾病或衰老过程相关的运动协调障碍的成年人的平衡和步态的积极影响。儿童纹理鞋垫的功效尚不清楚。我们的主要目的是确定进行一项涉及运动控制问题儿童的随机对照试验的可行性。次要目的是确定运动困难儿童的纹理鞋垫对粗大运动评估平衡域和耐力的有限功效。
    方法:评估者盲化,随机可行性研究。我们为5-12岁的儿童做广告,与现有的诊断或发育协调障碍或粗大运动技能水平评估为15百分位或以下的标准参考,澳大利亚两个城市的可靠和经过验证的规模。我们随机分配孩子只鞋子或鞋子和纹理鞋垫。我们收集了六个可行性领域的数据;需求(招聘),可接受性(通过面试)实施(坚持),实用性(通过访谈和不良事件),适应(通过访谈)和有限功效测试(基线和4周时6分钟步行测试和运动ABC-2平衡域)。
    结果:有15名儿童随机分为两组(8名仅接受鞋子,七个收到的鞋子和纹理鞋垫)。我们经历了适度的需求,有46名潜在参与者。鞋垫可以接受,然而,一些家长报告鞋类夹具问题需要修改。6分钟步行测试被描述为儿童有问题,尽管只有一个孩子完成。社会因素影响两组的依从性和鞋类佩戴时间。家庭报告约会地点和停车影响实用性。动力不足,对于不同的结局指标,观察到不显著的小到中等效应大小.平衡措施的改善有利于鞋和鞋垫组,而步态速度的增加有利于单鞋组。
    结论:我们的研究表明,这种试验设计通过修改是可行的,例如招募更大的多学科组织,提供velcro鞋具和使用较短的时间步行测试。此外,考虑到我们的初步研究,推进到更大的动力良好的随机对照试验是合理的,尽管动力不足,疗效发现。
    背景:本试验回顾性注册于澳大利亚和新西兰临床试验注册:ACTRN12624000160538。
    BACKGROUND: Motor coordination concerns are estimated to affect 5%-6% of school-aged children. Motor coordination concerns have variable impact on children\'s lives, with gait and balance often affected. Textured insoles have demonstrated positive impact on balance and gait in adults with motor coordination disorders related to disease or the ageing process. The efficacy of textured insoles in children is unknown. Our primary aim was to identify the feasibility of conducting a randomised controlled trial involving children with motor control issues. The secondary aim was to identify the limited efficacy of textured insoles on gross motor assessment balance domains and endurance in children with movement difficulties.
    METHODS: An assessor-blinded, randomised feasibility study. We advertised for children between the ages of 5-12 years, with an existing diagnosis or developmental coordination disorder or gross motor skill levels assessed as 15th percentile or below on a norm-referenced, reliable and validated scale across two cities within Australia. We randomly allocated children to shoes only or shoes and textured insoles. We collected data across six feasibility domains; demand (recruitment), acceptability (via interview) implementation (adherence), practicality (via interview and adverse events), adaptation (via interview) and limited efficacy testing (6-min walk test and balance domain of Movement ABC-2 at baseline and 4 weeks).
    RESULTS: There were 15 children randomised into two groups (eight received shoes alone, seven received shoes and textured insoles). We experienced moderate demand, with 46 potential participants. The insoles were acceptable, however, some parents reported footwear fixture issues requiring modification. The 6-min walk test was described as problematic for children, despite all but one child completing. Social factors impacted adherence and footwear wear time in both groups. Families reported appointment locations and parking impacting practicality. Underpowered, non-significant small to moderate effect sizes were observed for different outcome measures. Improvement in balance measures favoured the shoe and insole group, while gait velocity increase favoured the shoe only group.
    CONCLUSIONS: Our research indicates that this trial design is feasible with modifications such as recruiting with a larger multi-disciplinary organisation, providing velcro shoe fixtures and using a shorter timed walk test. Furthermore, progressing to a larger well-powered randomised control trial is justified considering our preliminary, albeit underpowered, efficacy findings.
    BACKGROUND: This trial was retrospectively registered with the Australian and New Zealand Clinical Trial Registration: ACTRN12624000160538.
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  • 文章类型: Journal Article
    目的:确定手术特征与使用视频喉镜(VL)的新生儿气管插管(NTI)成功之间的关联。
    方法:前瞻性单中心观察性研究。
    方法:第四纪新生儿重症监护病房。
    方法:在费城儿童医院需要NTI的婴儿。
    方法:对VLNTI记录进行评估,以评估假设与VLNTI成功相关的11个可观察到的手术特征。这些特征包括程序时间和性能的衡量标准,声门暴露和位置,和喉镜叶尖的位置。
    方法:VLNTI尝试成功。
    结果:共有109例患者经历了109次插管,164次插管尝试。首次尝试成功率为65%,整体相遇成功率为100%。成功的VLNTI尝试与较短的手术持续时间相关(36秒vs60秒,p<0.001),并提高了Cormack-Lehane等级(I级为63%,II级为49%,p<0.001)与不成功的NTI相比。在成功的NTI尝试中,比失败的尝试更常见的其他因素是喉镜刀片放置以抬起会厌(45%vs29%,p=0.002),更少的气管导管操作(3vs8,p<0.001)和左侧或非可视化的舌头位置(76%vs56%,p=0.009)。
    结论:我们确定了VL屏幕上可见的与NTI手术成功相关的手术特征。研究结果可能会改善VL如何用于教导和执行新生儿插管。
    OBJECTIVE: To identify associations between procedural characteristics and success of neonatal tracheal intubation (NTI) using video laryngoscopy (VL).
    METHODS: Prospective single-centre observational study.
    METHODS: Quaternary neonatal intensive care unit.
    METHODS: Infants requiring NTI at the Children\'s Hospital of Philadelphia.
    METHODS: VL NTI recordings were evaluated to assess 11 observable procedural characteristics hypothesised to be associated with VL NTI success. These characteristics included measures of procedural time and performance, glottic exposure and position, and laryngoscope blade tip location.
    METHODS: VL NTI attempt success.
    RESULTS: A total of 109 patients underwent 109 intubation encounters with 164 intubation attempts. The first attempt success rate was 65%, and the overall encounter success rate was 100%. Successful VL NTI attempts were associated with shorter procedural duration (36 s vs 60 s, p<0.001) and improved Cormack-Lehane grade (63% grade I vs 49% grade II, p<0.001) compared with unsuccessful NTIs. Other factors more common in successful NTI attempts than unsuccessful attempts were laryngoscope blade placement to lift the epiglottis (45% vs 29%, p=0.002), fewer tracheal tube manoeuvres (3 vs 8, p<0.001) and a left-sided or non-visualised tongue location (76% vs 56%, p=0.009).
    CONCLUSIONS: We identified procedural characteristics visible on the VL screen that are associated with NTI procedural success. Study results may improve how VL is used to teach and perform neonatal intubation.
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  • 文章类型: Journal Article
    目的:确定手术特征与使用视频喉镜(VL)的新生儿气管插管(NTI)成功之间的关联。
    方法:前瞻性单中心观察性研究。
    方法:第四纪新生儿重症监护病房。
    方法:在费城儿童医院需要NTI的婴儿。
    方法:对VLNTI记录进行评估,以评估假设与VLNTI成功相关的11个可观察到的手术特征。这些特征包括程序时间和性能的衡量标准,声门暴露和位置,和喉镜叶尖的位置。
    方法:VLNTI尝试成功。
    结果:共有109例患者经历了109次插管,164次插管尝试。首次尝试成功率为65%,整体相遇成功率为100%。成功的VLNTI尝试与较短的手术持续时间相关(36秒vs60秒,p<0.001),并提高了Cormack-Lehane等级(I级为63%,II级为49%,p<0.001)与不成功的NTI相比。在成功的NTI尝试中,比失败的尝试更常见的其他因素是喉镜刀片放置以抬起会厌(45%vs29%,p=0.002),更少的气管导管操作(3vs8,p<0.001)和左侧或非可视化的舌头位置(76%vs56%,p=0.009)。
    结论:我们确定了VL屏幕上可见的与NTI手术成功相关的手术特征。研究结果可能会改善VL如何用于教导和执行新生儿插管。
    OBJECTIVE: To identify associations between procedural characteristics and success of neonatal tracheal intubation (NTI) using video laryngoscopy (VL).
    METHODS: Prospective single-centre observational study.
    METHODS: Quaternary neonatal intensive care unit.
    METHODS: Infants requiring NTI at the Children\'s Hospital of Philadelphia.
    METHODS: VL NTI recordings were evaluated to assess 11 observable procedural characteristics hypothesised to be associated with VL NTI success. These characteristics included measures of procedural time and performance, glottic exposure and position, and laryngoscope blade tip location.
    METHODS: VL NTI attempt success.
    RESULTS: A total of 109 patients underwent 109 intubation encounters with 164 intubation attempts. The first attempt success rate was 65%, and the overall encounter success rate was 100%. Successful VL NTI attempts were associated with shorter procedural duration (36 s vs 60 s, p<0.001) and improved Cormack-Lehane grade (63% grade I vs 49% grade II, p<0.001) compared with unsuccessful NTIs. Other factors more common in successful NTI attempts than unsuccessful attempts were laryngoscope blade placement to lift the epiglottis (45% vs 29%, p=0.002), fewer tracheal tube manoeuvres (3 vs 8, p<0.001) and a left-sided or non-visualised tongue location (76% vs 56%, p=0.009).
    CONCLUSIONS: We identified procedural characteristics visible on the VL screen that are associated with NTI procedural success. Study results may improve how VL is used to teach and perform neonatal intubation.
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  • 文章类型: Journal Article
    背景:乳脂球膜(MFGM)是哺乳动物乳和人乳中的复杂脂质-蛋白质结构,在母乳替代品中基本上不存在。这项试验的目的是调查提供富含MFGM的婴儿配方奶粉与标准婴儿配方奶粉是否可以改善完全配方喂养的足月婴儿在12月龄时的认知发育。
    方法:这是一个随机的,控制,临床医生盲,由一个研究中心(医学研究所)在阿德莱德(澳大利亚)郊区社区招募的两个平行配方喂养组和一个母乳喂养参考组的研究者盲法和参与者盲法试验.健康,独家配方喂养,单身人士,8周龄以下的足月出生婴儿从入组至12月龄随机接受补充MFGM的配方奶粉(干预)或标准婴儿配方奶粉(对照).参照组未提供配方。主要结果是Bayley婴儿发育量表的认知量表,第四版(Bayley-IV)在12个月。次要结局是24个月时的Bayley-IV认知量表,其他Bayley-IV领域(语言,电机,情感和行为发展)在12个月和24个月大时,4个月和9个月大的婴儿注意,12个月和24个月大的家长语言,父母在6个月和18个月大的发育以及成长,研究配方的耐受性和安全性。为了确保至少有80%的能力来检测平均Bayley-IV认知得分的5分差异,每组招募>200名婴儿。
    背景:妇女儿童健康网络人类研究伦理委员会审查并批准了该研究(HREC/19/WCHN/140)。看护者在参加试验之前给予书面知情同意书。这项研究的结果将通过同行评审的出版物和会议演示文稿进行传播。
    背景:ACTRN12620000552987;澳大利亚和新西兰临床试验注册:anzctr.org.au.
    BACKGROUND: Milk fat globule membrane (MFGM) is a complex lipid-protein structure in mammalian milk and human milk that is largely absent from breastmilk substitutes. The objective of this trial is to investigate whether providing infant formula enriched with MFGM versus standard infant formula improves cognitive development at 12 months of age in exclusively formula-fed full-term infants.
    METHODS: This is a randomised, controlled, clinician-blinded, researcher-blinded and participant-blinded trial of two parallel formula-fed groups and a breastfed reference group that were recruited in the suburban Adelaide (Australia) community by a single study centre (a medical research institute). Healthy, exclusively formula-fed, singleton, term-born infants under 8 weeks of age were randomised to either an MFGM-supplemented formula (intervention) or standard infant formula (control) from enrolment until 12 months of age. The reference group was not provided with formula. The primary outcome is the Cognitive Scale of the Bayley Scales of Infant Development, Fourth Edition (Bayley-IV) at 12 months. Secondary outcomes are the Bayley-IV Cognitive Scale at 24 months, other Bayley-IV domains (language, motor, emotional and behavioural development) at 12 and 24 months of age, infant attention at 4 and 9 months of age, parent-rated language at 12 and 24 months of age, parent-rated development at 6 and 18 months of age as well as growth, tolerance and safety of the study formula. To ensure at least 80% power to detect a 5-point difference in the mean Bayley-IV cognitive score, >200 infants were recruited in each group.
    BACKGROUND: The Women\'s and Children Health Network Human Research Ethics Committee reviewed and approved the study (HREC/19/WCHN/140). Caregivers gave written informed consent prior to enrolling in the trial. Findings of this study will be disseminated through peer-reviewed publications and conference presentations.
    BACKGROUND: ACTRN12620000552987; Australian and New Zealand Clinical Trial Registry: anzctr.org.au.
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  • 文章类型: Journal Article
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