Delayed Cord Clamping with Oxygen In Extremely Low Gestational Age Infants (DOXIE)
极低胎龄婴儿延迟供氧断脐 (DOXIE)
基本信息
- 批准号:10373881
- 负责人:
- 金额:$ 7.72万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-01-15 至 2023-12-31
- 项目状态:已结题
- 来源:
- 关键词:AdvocateAirAlveolarAnimalsBirthBlindedBloodBlood flowBrainBreathingCardiacCerebrovascular CirculationCerebrumCessation of lifeClinicalClosure by clampContinuous Positive Airway PressureDataDelivery RoomsDiscipline of obstetricsDiseaseDouble-Blind MethodDuct (organ) structureEchocardiographyEnrollmentExtremely low gestational age newbornGasesGestational AgeHeadHeart RateHemorrhageHourHypoxemiaHypoxiaIncidenceInfantInfant CareInterventionLegal patentLifeLungMasksMeasurementMeasuresMeta-AnalysisMethodsMilkMorbidity - disease rateMovementMulticenter TrialsNatureNear-Infrared SpectroscopyNeonatalNewborn InfantOrganOutcomeOxygenOxygen Therapy CareOxygen saturation measurementPartial PressurePeripheralPhysiologicalPilot ProjectsPregnancyPremature InfantProtocols documentationRandomizedRandomized Controlled TrialsRespirationResuscitationSafetyStreamTidal VolumeTimeTracheaUltrasonographyUmbilical cord structureVenousVideo RecordingWorkarmdesigndisabilityface maskfeasibility testingglottishemodynamicsimprovedintraventricular hemorrhagemortalityorgan injuryoxygen toxicitypilot trialpositive airway pressurepostnatalpressurepreterm newbornpreventrespiratorysafety and feasibilitysupplemental oxygentrial comparingventilation
项目摘要
Background: Current newborn care practice is to delay clamping and cutting the umbilical cord to allow for
hemodynamic stabilization. Supported by numerous randomized controlled trials and meta-analyses, delayed
cord clamping (DCC) is endorsed by both neonatal and obstetrical governing bodies. Limited oxygenation data
on DCC in extremely preterm infants suggests they remain hypoxic immediately after birth. This may be due to
differences in how infants transition during DCC. Immediately after delivery, extremely preterm infants attempt
to initiate lung aeration and gas exchange. Animal studies have demonstrated that delaying clamping of the
umbilical cord until breathing is established avoids adverse cerebral and cardiac hemodynamics, which may
reduce bleeding in the brain, including severe intraventricular hemorrhage (sIVH). In a multicenter trial comparing
DCC to umbilical cord milking, 76 percent of preterm newborns between 230-276 weeks gestation who received
DCC without respiratory support initiated respirations prior to cord clamping, yet still had relative hypoxia
demonstrated by a low 5-minute arterial oxygen saturation (SpO2 73 percent (95% CI 71.4, 75.6)). Two recent
analyses found that preterm infants with a 5-minute SpO2 < 80 percent were more likely to have sIVH or
death. Supplemental oxygen provided during DCC with resultant lung aeration may decrease significant
morbidities and death in extremely preterm infants. A pilot study with detailed assessments of hemodynamics
and organ function immediately after birth is needed to determine the efficacy and safety of providing 100 percent
oxygen during DCC.
Design: This randomized double-blinded pilot trial will enroll 140 extremely low gestational age infants (230-
276 weeks gestation) who receive DCC of at least 60 seconds with carefully detailed hemodynamic assessments
and simultaneous video recordings. The study will evaluate infants providing continuous positive airway pressure
(CPAP) and/or positive pressure ventilation (PPV) by face mask with an inspired fractional oxygen (FiO2) of 1.0
(HI Group) during DCC compared to infants given mask CPAP/PPV with an inspired FiO2 of 0.30 during DCC
(LO Group). Due to the nature of the intervention, both arms receive CPAP/PPV with identical cord clamping
times and respiratory support, the study can be blinded by covering the oxygen blender, avoiding any postnatal
treatment bias. Once the cord is clamped and cut, each infant is resuscitated as per usual protocol (CPAP/PPV
with a starting FiO2 0.30) by the clinical team. We will collect physiological parameters from birth through the first
24 hours of life (including detailed breathing assessments from video recordings at birth/ resuscitation suite). If
we reduce hypoxia in extremely preterm infants by providing supplemental oxygen during the period of delayed
cord clamping, there may be a dramatic reduction in morbidity and mortality. Depending on the findings, results
will be used to design a more definitive larger, multicenter R01 trial powered for important clinical outcomes such
as severe IVH or death and neurodevelopmental outcomes.
背景:目前的新生儿护理实践是推迟夹住和剪断脐带,以允许
血流动力学稳定。在大量随机对照试验和荟萃分析的支持下,
脐带夹紧术(DCC)得到了新生儿和产科管理机构的认可。氧合数据有限
极早产儿的DCC表明他们在出生后立即保持缺氧。这可能是由于
婴儿在DCC期间如何过渡的差异。极早产儿在分娩后立即尝试
以启动肺通气和气体交换。动物研究表明,延迟钳夹
脐带直到呼吸建立避免不利的大脑和心脏血液动力学,这可能
减少脑出血,包括严重脑室内出血(sIVH)。在一项多中心试验中,
DCC到脐带挤奶,76%的妊娠230-276周的早产新生儿接受了DCC,
在没有呼吸支持的情况下,DCC在脐带夹紧之前开始呼吸,但仍然存在相对缺氧
表现为5分钟动脉血氧饱和度较低(SpO 2 73%(95% CI 71.4,75.6))。最近的两
分析发现,5分钟SpO 2 <80%的早产儿更有可能患有sIVH,
死亡在DCC期间提供的补充氧气导致肺通气可能会显著减少
极早产儿的发病率和死亡率。详细评估血流动力学的初步研究
需要在出生后立即进行器官功能检查,以确定100%
DCC期间的氧气。
设计:本随机双盲试验将纳入140例极低胎龄儿(230- 240岁),
妊娠276周),接受至少60秒的DCC,并进行仔细详细的血流动力学评估
和同步录像。这项研究将评估婴儿提供持续气道正压通气
(CPAP)和/或通过面罩进行正压通气(PPV),吸入氧气分数(FiO 2)为1.0
(HI组)与DCC期间吸入FiO 2为0.30的面罩CPAP/PPV婴儿相比
(LO组)。由于干预的性质,双臂均接受CPAP/PPV,并使用相同的脐带夹持
时间和呼吸支持,研究可以通过覆盖氧气混合器来设盲,避免任何产后
治疗偏倚一旦脐带被夹住并切断,每个婴儿都按照常规方案(CPAP/PPV)进行复苏
初始FiO 2为0.30)。我们将收集从出生到第一个孩子的生理参数
24小时生命(包括出生/复苏室视频记录的详细呼吸评估)。如果
我们通过在延迟给药期间提供补充氧气来减少极早产儿的缺氧。
脐带夹紧,发病率和死亡率可能会显着降低。根据调查结果,结果
将用于设计更明确的大型多中心R 01试验,以获得重要的临床结局,
严重IVH或死亡和神经发育结局。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
Anup C Katheria其他文献
Anup C Katheria的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('Anup C Katheria', 18)}}的其他基金
Sharp Neonatal Research Institute Clinical Center (Sharp NRI-CC)
夏普新生儿研究所临床中心 (Sharp NRI-CC)
- 批准号:
10683030 - 财政年份:2023
- 资助金额:
$ 7.72万 - 项目类别:
Delayed Cord Clamping with Oxygen In Extremely Low Gestational Age Infants (DOXIE)
极低胎龄婴儿延迟供氧断脐 (DOXIE)
- 批准号:
10549378 - 财政年份:2022
- 资助金额:
$ 7.72万 - 项目类别:
The NICU Antibiotics and Outcomes (NANO) Trial
NICU 抗生素和结果 (NANO) 试验
- 批准号:
10213792 - 财政年份:2019
- 资助金额:
$ 7.72万 - 项目类别:
The NICU Antibiotics and Outcomes (NANO) Trial
NICU 抗生素和结果 (NANO) 试验
- 批准号:
10677891 - 财政年份:2019
- 资助金额:
$ 7.72万 - 项目类别:
The NICU Antibiotics and Outcomes (NANO) Trial
NICU 抗生素和结果 (NANO) 试验
- 批准号:
10457371 - 财政年份:2019
- 资助金额:
$ 7.72万 - 项目类别:
The NICU Antibiotics and Outcomes (NANO) Trial
NICU 抗生素和结果 (NANO) 试验
- 批准号:
10018511 - 财政年份:2019
- 资助金额:
$ 7.72万 - 项目类别:
Umbilical Cord Milking in Non Vigorous Infants (the MINVI Trial)
非活力婴儿的脐带挤奶(MINVI 试验)
- 批准号:
10401868 - 财政年份:2018
- 资助金额:
$ 7.72万 - 项目类别:
Umbilical Cord Milking in Non Vigorous Infants (the MINVI Trial)
非活力婴儿的脐带挤奶(MINVI 试验)
- 批准号:
10188576 - 财政年份:2018
- 资助金额:
$ 7.72万 - 项目类别:
Premature Infants Receiving Cord Milking Or Delayed Cord Clamping
接受脐带挤奶或延迟断脐的早产儿
- 批准号:
9914830 - 财政年份:2017
- 资助金额:
$ 7.72万 - 项目类别:
Premature Infants Receiving Cord Milking Or Delayed Cord Clamping
接受脐带挤奶或延迟断脐的早产儿
- 批准号:
9452999 - 财政年份:2017
- 资助金额:
$ 7.72万 - 项目类别:
相似国自然基金
湍流和化学交互作用对H2-Air-H2O微混燃烧中NO生成的影响研究
- 批准号:51976048
- 批准年份:2019
- 资助金额:61.0 万元
- 项目类别:面上项目
相似海外基金
RII Track-4:NSF: From the Ground Up to the Air Above Coastal Dunes: How Groundwater and Evaporation Affect the Mechanism of Wind Erosion
RII Track-4:NSF:从地面到沿海沙丘上方的空气:地下水和蒸发如何影响风蚀机制
- 批准号:
2327346 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
Standard Grant
SBIR Phase I: High-Efficiency Liquid Desiccant Regenerator for Desiccant Enhanced Evaporative Air Conditioning
SBIR 第一阶段:用于干燥剂增强蒸发空调的高效液体干燥剂再生器
- 批准号:
2335500 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
Standard Grant
Catalyzing Sustainable Air Travel: Unveiling Consumer Willingness to Pay for Sustainable Aviation Fuel through Information Treatment in Choice Experiment and Cross-Country Analysis
促进可持续航空旅行:通过选择实验和跨国分析中的信息处理揭示消费者支付可持续航空燃油的意愿
- 批准号:
24K16365 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
Grant-in-Aid for Early-Career Scientists
COMPAS: co integration of microelectronics and photonics for air and water sensors
COMPAS:微电子学和光子学的共同集成,用于空气和水传感器
- 批准号:
10108154 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
EU-Funded
Simulating Urban Air Pollution In The Lab
在实验室模拟城市空气污染
- 批准号:
MR/Y020014/1 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
Fellowship
Collaborative Research: Phenotypic and lineage diversification after key innovation(s): multiple evolutionary pathways to air-breathing in labyrinth fishes and their allies
合作研究:关键创新后的表型和谱系多样化:迷宫鱼及其盟友呼吸空气的多种进化途径
- 批准号:
2333683 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
Continuing Grant
Collaborative Research: Phenotypic and lineage diversification after key innovation(s): multiple evolutionary pathways to air-breathing in labyrinth fishes and their allies
合作研究:关键创新后的表型和谱系多样化:迷宫鱼及其盟友呼吸空气的多种进化途径
- 批准号:
2333684 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
Continuing Grant
CRII: CSR: Towards an Edge-enabled Software-Defined Vehicle Framework for Dynamic Over-the-Air Updates
CRII:CSR:迈向支持边缘的软件定义车辆框架,用于动态无线更新
- 批准号:
2348151 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
Standard Grant
Development of a low-pressure loss air purification device using rotating porous media and a proposal for its use in ventilation systems
使用旋转多孔介质的低压损失空气净化装置的开发及其在通风系统中的使用建议
- 批准号:
24K17404 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
Grant-in-Aid for Early-Career Scientists
AIR QUALITY AND HEALTH IMPACT OF PRIMARY SEMI-VOLATILE AND SECONDARY PARTICLES AND THEIR ABATEMENT
一次半挥发性颗粒和二次颗粒对空气质量和健康的影响及其消除
- 批准号:
10100997 - 财政年份:2024
- 资助金额:
$ 7.72万 - 项目类别:
EU-Funded