ACTRN12619000742178招募中未知
Effect of automated control of oxygen administration on oxygen saturation targeting in term newborns and young infants requiring mechanical respiratory support and oxygen therapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- o limit 至 9 Months（—）
- 性别
- All
入选标准
- •Term newborns with hypoxic respiratory failure, and young infants with respiratory insufficiency related to respiratory tract infection, fulfilling the eligibility criteria outlined below.
- •Participants will be assigned to a randomised trial treatment only if they meet all of the inclusion criteria and none of the exclusion criteria.
- •Inclusion criteria
- •Each participant must meet all of the following criteria in either study population (‘Study group A’ or Study group B’) to be enrolled in the study.
- •Study group A: Term and near-term infants requiring mechanical respiratory support and oxygen therapy of any duration due to hypoxic respiratory failure (HRF).
- •Gestation at birth greater than or equal to 35 completed weeks.
- •Chronological age less than or equal to 2 months.
- •HRF related to any of parenchymal lung disease, neonatal acute respiratory distress syndrome, pulmonary hypertension or diaphragmatic hernia
- •Receiving non-invasive respiratory support (CPAP and HFNC), or intubated and mechanically ventilated using any of the modes available with the SLE6000 ventilator.
- •Study group B: Young infants requiring non-invasive or invasive mechanical respiratory support and supplemental oxygen therapy of any duration secondary to RTI.
- •Any gestation at birth.
- •Chronological age less than or equal to 9 months and corrected gestational age less than or equal to 6 months
- •Respiratory insufficiency due to respiratory tract infection (viral or bacterial)
- •Receiving non-invasive respiratory support (CPAP and HFNC), or intubated and mechanically ventilated using any of the modes available with the SLE6000 ventilator.
- •For participants in both groups, the following inclusion criteria must be met:
- •Supplemental oxygen therapy being administered at study entry (baseline oxygen requirement at least 30%).
- •SLE6000 ventilator with OxyGenie® option available for the study.
- •Research team available to commence recording.
- •Agreement of treating clinicians that the participant is appropriate for study.
排除标准
- •Exclusion criteria (common to both study groups):
- •Cardiorespiratory instability that precludes entry into a study.
- •Change in mode of respiratory support anticipated in next 24 hours.
研究者
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