Effects of Oxygen and Functional Residual Capacity on the Oxygen Saturations of Infants ≥ 35 Weeks Gestation During Delivery Room Resuscitation.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary outcome measure is the proportion of infants achieving a stable oxygen saturation of ≥80%. To be considered stable, the oxygen saturation must remain at or above the predetermined target saturation for at least 30 seconds.
研究概览
简要总结
Currently, newborns receive 100% supplemental oxygen by free flow when they remain cyanotic despite demonstrating regular respiratory effort. Resuscitating infants with continuous positive airway pressure (CPAP) in room air may improve oxygen saturations more quickly than providing FFO2 because of its ability to establish functional residual capacity in the lungs. Our primary hypothesis is that in this blinded, randomized control trial, more infants (≥35 weeks gestation) resuscitated with CPAP in room air will have an oxygen saturation ≥80% at five minutes of age compared to infants resuscitated with the 50% FFO2.
详细描述
INTERVENTION Resuscitation will proceed as per standard of care and infants are only to receive respiratory support if they remain cyanotic despite 30 seconds of spontaneous regular respirations. All infants will have a pulse oximetry probe placed on the right hand (pre-ductal position) immediately after birth. Alarm limits will not be set. The pulse oximetry probe will first be placed on the infant and then attached to the cable connected to the pulse oximeter as this has been shown to result in a shorter time to detecting a good quality signal. The pulse oximeter will be set at "maximum" sensitivity with an averaging time of 2 seconds.
Randomization will occur at the time of delivery. Infants that meet the entry criteria will be randomized to resuscitation with one of two Neopuff CPAP circuits:
GROUP 1 (21% CPAP) - infants will receive CPAP with 21% oxygen at 6 cm H2O continuously for at least 5 minutes.
GROUP 2 (50% FFO2) - infants will receive the equivalent of 100% FFO2 for at least 5 minutes. Note that infants receiving 100% FFO2 actually inspire approximately 50% oxygen because of entrained room air. To allow us to maintain blinding of the intervention, infants in the FFO2 group will actually receive 50% oxygen provided via a T-piece infant resuscitator that has been modified so as not to deliver any pressure to the airways.
The FiO2 (21% or 50%) will be set by the study investigator attending the delivery. An anaesthesia monitor (Datex Ohmeda) will be connected in-line between the Neopuff T-piece and the face mask to record airway pressures, end tidal carbon dioxide levels and concentration of inspired oxygen (to confirm that infant are receiving either 21% or 50% oxygen).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Minute（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥35 weeks gestational age
- •Neonatal resuscitation team present at delivery
- •Central cyanosis despite 60 seconds of spontaneous respirations in room air. Sustained respirations are defined as: spontaneous breathing that is regular in rhythm and sufficient to maintain a heart rate ≥100 beats per minute such that provision of artificial tidal volume breathing is not required.
排除标准
- •Lethal anomalies
- •Cyanotic congenital heart disease
- •Known hemoglobinopathy
- •Risk of persistent pulmonary hypertension (eg, meconium aspiration, conditions associated with pulmonary hypoplasia such as prolonged)
- •Known anatomical lung abnormalities
- •Conditions where CPAP is contraindicated (eg, congenital diaphragmatic hernia). Mode of delivery will not be a criterion for inclusion or exclusion.
结局指标
主要结局
The primary outcome measure is the proportion of infants achieving a stable oxygen saturation of ≥80%. To be considered stable, the oxygen saturation must remain at or above the predetermined target saturation for at least 30 seconds.
时间窗: 5 minutes after birth
次要结局
- The secondary outcome measure is the proportion of infants achieving a stable oxygen saturation of ≥90%.(10 minutes after birth)
研究者
Yacov Rabi
Principal Investigator
University of Calgary