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
• 负责人: Anup C Katheria
• 金额: $ 7.72万
• 依托单位: SHARP MEMORIAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-15 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10549378
• 关键词: Advocate; Air; Alveolar; Animals; Birth; Blinded; Blood; Blood flow; Brain; Breathing; Cardiac; Cerebrovascular Circulation; Cerebrum; Cessation of life; Clinical; Closure by clamp; Continuous Positive Airway Pressure; Data; Delivery Rooms; Discipline of obstetrics; Disease; Double-Blind Method; Duct (organ) structure; Echocardiography; Enrollment; Extremely low gestational age newborn; Gases; Gestational Age; Head; Heart Rate; Hemorrhage; Hour; Hypoxemia; Hypoxia; Incidence; Infant; Infant Care; Intervention; Legal patent; Life; Lung; Masks; Measurement; Measures; Meta-Analysis; Methods; Milk; Morbidity - disease rate; Movement; Multicenter Trials; Nature; Near-Infrared Spectroscopy; Neonatal; Newborn Infant; Organ; Outcome; Oxygen; Oxygen Therapy Care; Oxygen saturation measurement; Partial Pressure; Peripheral; Physiological; Pilot Projects; Pregnancy; Premature Infant; Protocols documentation; Randomized; Randomized, Controlled Trials; Respiration; Resuscitation; Safety; Stream; Tidal Volume; Trachea; Ultrasonography; Umbilical cord structure; Umbilicus; Venous; Video Recording; Work; arm; design; disability; efficacy evaluation; extreme prematurity; face mask; feasibility testing; glottis; hemodynamics; improved; intraventricular hemorrhage; mortality; organ injury; oxygen toxicity; pilot trial; postnatal; pressure; preterm newborn; prevent; respiratory; safety and feasibility; supplemental oxygen; trial comparing; ventilation; Advocate; Air; Alveolar; Animals; Birth; Blinded; Blood; Blood flow; Brain; Breathing; Cardiac; Cerebrovascular Circulation; Cerebrum; Cessation of life; Clinical; Closure by clamp; Continuous Positive Airway Pressure; Data; Delivery Rooms; Discipline of obstetrics; Disease; Double-Blind Method; Duct (organ) structure; Echocardiography; Enrollment; Extremely low gestational age newborn; Gases; Gestational Age; Head; Heart Rate; Hemorrhage; Hour; Hypoxemia; Hypoxia; Incidence; Infant; Infant Care; Intervention; Legal patent; Life; Lung; Masks; Measurement; Measures; Meta-Analysis; Methods; Milk; Morbidity - disease rate; Movement; Multicenter Trials; Nature; Near-Infrared Spectroscopy; Neonatal; Newborn Infant; Organ; Outcome; Oxygen; Oxygen Therapy Care; Oxygen saturation measurement; Partial Pressure; Peripheral; Physiological; Pilot Projects; Pregnancy; Premature Infant; Protocols documentation; Randomized; Randomized, Controlled Trials; Respiration; Resuscitation; Safety; Stream; Tidal Volume; Trachea; Ultrasonography; Umbilical cord structure; Umbilicus; Venous; Video Recording; Work; arm; design; disability; efficacy evaluation; extreme prematurity; face mask; feasibility testing; glottis; hemodynamics; improved; intraventricular hemorrhage; mortality; organ injury; oxygen toxicity; pilot trial; postnatal; pressure; preterm newborn; prevent; respiratory; safety and feasibility; supplemental oxygen; trial comparing; ventilation

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：当前的新生儿护理实践是延迟夹紧和切割脐带以允许 血液动力学稳定。在众多随机对照试验和荟萃分析的支持下，延迟 绳索夹具（DCC）得到了新生儿和产科理事机构的认可。有限的氧合数据 在极端婴儿的DCC上表明，出生后立即保持低氧。这可能是由于 DCC期间婴儿过渡的差异。分娩后立即尝试过早产儿 启动肺气和气体交换。动物研究表明，延迟夹紧 脐带直至建立呼吸，避免了大脑和心脏血液动力学不良，可能 减少大脑出血，包括严重的脑室出血（SIVH）。在比较的多中心试验中 DCC到脐带挤奶，在230-276周妊娠之间的早产新生儿中有76％接受 无呼吸支持的DCC在绳子夹紧之前开始呼吸，但仍然有相对缺氧 通过低5分钟的动脉氧饱和度（SPO2 73％（95％CI 71.4，75.6））证明。最近两个 分析发现5分钟Spo2 <80％的早产儿更有可能患有SIVH或 死亡。在DCC期间提供的补充氧气，导致肺曝气可能会降低显着 极端婴儿的病态和死亡。一项试点研究，对血液动力学的详细评估 需要在出生后立即进行器官功能，以确定提供100％的功效和安全性 DCC期间的氧气。 设计：这项随机双盲试验试验将招募140名极低的妊娠年龄婴儿（230-- 妊娠276周），他们接受至少60秒的DCC，并经过精心详细的血液动力学评估 和同时的视频录制。该研究将评估提供持续阳性气道压力的婴儿 （CPAP）和/或正压通气（PPV），面膜​​具有1.0的启发分数（FIO2） （HI组）在DCC期间，与给予蒙版CPAP/PPV的婴儿相比，DCC期间的启发性FIO2为0.30 （LO组）。由于干预的性质，两个臂都接受CPAP/PPV，并带有相同的绳子夹紧 时间和呼吸支持，可以通过覆盖氧气搅拌器来蒙蔽研究，避免产后 治疗偏见。绳子夹紧并切割绳子后，每个婴儿都按照通常的协议（CPAP/PPV）复苏 由临床团队的起始FIO2 0.30）。我们将收集从出生到第一个的生理参数 24小时的生命（包括出生/复苏套件中视频记录的详细呼吸评估）。如果 我们通过在延迟期间提供补充氧气来减少非常早产的婴儿的缺氧 绳子夹紧，发病率和死亡率可能会大大降低。根据发现，结果 将用于设计更大的更大的多中心R01试验，该试验用于重要的临床结果。 严重的IVH或死亡和神经发育结果。