Prone or Supine Effect of Immediate Positioning After Scheduled Caesarean Delivery on Respiratory Outcomes in Full Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Administration of positive pressure ventilation and/or oxygen in prone vs supine groups
研究概览
简要总结
Investigators will compare 500 full term babies delivered by SCD randomized into two groups, prone or supine position. Investigators will use a Panda warmer with built in Nellcor pulse oximeter. Each infant will have heart rate (HR), oxygen saturation via pulse oximetry, respiratory rate and respiratory effort documented every 1 minute for the first 5 minutes of life; beyond the initial 5minutes of life, monitoring as well as infant's management will be done as per current Weiler hospital protocols. The intervention group will be placed in prone position for first five minutes immediately after birth, and then changed to supine position. The control group will be placed supine from birth. Investigators will check for the incidence and severity of RD, supplemental oxygen need and duration, positive pressure ventilation (PPV) need and duration or other use of respiratory support (intubation). Additionally, investigators will record the number of infants requiring admission to the NICU in each group, days of ventilatory support as well as the length of hospitalization.
详细描述
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Consent obtained prior to actual operative delivery and anesthesia
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Prior to start of surgery an opaque envelope with random selection of post delivery position, supine or prone, is opened
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Pediatric team confirms with Obstetrician and delivery team the position in which the infant will be given to pediatrics
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Pediatric team member accepting the infant stays by the operating room table to observe the delivery At actual delivery, the Panda radiant warmer Apgar clock will be started by a Pediatric team member positioned at the warmer when the baby is delivered. Vitals signs of HR, color and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be noted. The Apgar clock is available to document the timing of the minute intervals heart rate and oxygen saturations on the preprinted grid of the survey data sheet.
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When a Group A (supine) infant's transfer is made to Pediatrics, the infant will be kept in the supine position in transit to warmer and on warmer until first towel drying completed, 30 - 60 seconds, consistent with NRP protocol. Pulse oximetry and temperature probe will be placed. Vitals signs of HR, color and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be noted.
When a Group B (start in prone position) the obstetrician places the baby in prone position, clamps and cuts cord. The baby is given to Pediatrics in the prone position. The infant will be kept in the prone position in transit to warmer and on warmer for first towel drying completed. Pulse oximetry and temperature probe will be placed. Vitals signs of HR, RR and oxygen saturations will be recorded each minute for first five minutes. Respiratory effort will be documented.
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As toweling is changed the baby in prone position continues as such until five minutes pass. After five minutes the baby is turned to supine position as per standard NRP protocol.
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Decision to initiate positive pressure ventilation and /or oxygen supplementation will be guided by published NRP 2010 lower saturation targets (1 min <60%, 2 min <65%, 3 min <70%, 4 min <75%, 5 min <80%) and/or by grunting, retractions ; discontinuation by high saturation targets (1min >65%, 2 min >70%, 3min >>75%, 4 min >80%, 5 min >85%) and resolution of respiratory distress. Positive pressure ventilation will be delivered via Neopuff device in supine position (both groups); CPAP 5cm 21% initially, then the amount of oxygen will be titrated to meet oxygen saturation target for given minute of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstetrical patients delivering at Weiler Hospital.
- •Any woman not in labor, who is undergoing scheduled caesarean deliveries at term (37 - 42 completed weeks of gestation),
排除标准
- •Women with prior rupture of membranes
- •Women receiving magnesium sulfate
- •Women with known illegal drug history
- •fetus with known congenital anomalies or if meconium stained fluid is present.
- •mother with maternal fever, chorioamnionitis
- •babies experiencing fetal distress e.g. abnormal fetal heart tracing,
- •non vigorous newborn at birth (defined as per NRP guidelines as infant with apnea/gasping, heart rate <100/min, poor tone).
研究组 & 干预措施
prone
Prone positioned after delivery
干预措施: positioning (Other)
supine
Supine positioned after delivery
干预措施: positioning (Other)
结局指标
主要结局
Administration of positive pressure ventilation and/or oxygen in prone vs supine groups
时间窗: 30 minutes
any administration of positive pressure ventilation and /or oxygen
次要结局
- Differences in respiratory rate between prone and supine groups(5 minutes)
- Differences in pulse oximetry recordings between prone and supine groups(5 minutes)
- Differences in heart rate between prone and supine groups(5 minutes)
- Differences in neonatal intensive care admission rates between prone and supine groups(30 minutes)
研究者
Thomas Havranek
Attending Neonatologist, Associate Professor of Pediatrics
Montefiore Medical Center