Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

赞助:

合作者:

信息的提供 (责任方):

Nelson Claure，University of Miami

追踪信息

首次提交日期 ^ICMJE

October 2, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 31, 2018

预计主要完成日期

October 31, 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

ventilatory stability by frequency of central apnea[ Time Frame: 2 hours ]

ventilatory stability by frequency of obstructive apnea[ Time Frame: 2 hours ]

ventilatory stability by density of periodic breathing[ Time Frame: 2 hours ]

ventilatory stability by time series of inter-breath intervals[ Time Frame: 2 hours ]

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

oxygenation stability by frequency of intermittent hypoxemia episodes[ Time Frame: 2 hours ]
frequency of episodes with SpO2 < 80%
frequency of bradycardia episodes[ Time Frame: 2 hours ]
frequency of episodes with HR < 100 bpm

描述性信息

简略标题 ^ICMJE

Arterial Oxygen Saturation on Ventilatory Stability in Extremely Premature Infants

正式标题 ^ICMJE

Impact of Arterial Oxygen Saturation Range on Ventilatory Stability in Extremely Premature Infants

简要概况

This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2), both within the clinically recommended range of 90- 95%. The specific objective of this study to evaluate the impact of targeting SpO2 within 93-95% compared to the 90-92% range on ventilatory stability in premature infants of 23-29 weeks gestational age (GA).

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Crossover Assignment
干预模型描述: This is a prospective crossover study to compare the within-subject effect of the two target ranges of arterial oxygen saturation (SpO2, 93-95% vs 90-92%) on ventilatory stability in premature infants.
盲法: Interventional
盲法描述:
主要目的: Other

适用条件 ^ICMJE

干预项目 ^ICMJE

Other: Targeting SpO2 at 93-95%
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours
Other: Targeting SpO2 at 90-92%
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.

研究工具

Other: Targeting SpO2 at 93-95% followed by targeting at 90-92%
FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.
Other: Targeting SpO2 at 90-92% followed by targeting at 93-95%
FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours, followed by FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

October 31, 2019

预计主要完成日期

October 31, 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 23 0/7- 29 6/7 weeks gestational age - Postnatal age ≥ 14 days - Requiring FiO2 ≥ 0.25 to keep SpO2 90-95% - Parental informed consent Exclusion Criteria: - Severe congenital anomalies that may affect pulmonary or neurosensory development - Severe CNS pathology that may alter respiratory control function

性别

参与研究的性别:

All

年龄

最小年龄：N/A ，最大年龄：18 Weeks

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Nelson Claure，University of Miami

研究赞助商 ^ICMJE

University of Miami

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Nelson Claure, MSc, PhD University of Miami
Principal Investigator: Eduardo Bancalari, MD University of Miami
Principal Investigator: Deepak Jain, MD University of Miami
Principal Investigator: Waleed Kurtom, MD Jackson Health System

PRS 账户

University of Miami

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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