Role of Endotracheal Suction on the Occurrence of Meconium Aspiration Syndrome in Non-vigorous Meconium Stained Neonates- A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 2
- 主要终点
- Incidence of MAS and death due to all cause
研究概览
简要总结
The purpose of this study is to evaluate the role of endotracheal suction on the occurrence of meconium aspiration syndrome in depressed meconium stained babies. Meconium aspiration syndrome (MAS) is believed to result from aspiration of meconium and consequent chemical pneumonitis. Meconium can be aspirated into the lungs in the womb as well. Meconium in the distal airways is not accessible to endotracheal (ET) suction which clears only the windpipe. Furthermore there is growing evidence in support of asphyxia-hypoxia-acidosis in the causation of lung disease. Moreover, in the absence of a clear role of ET suction in depressed meconium stained newborns, critical time could be lost in assessment, intubation and ET suction (range: 30 seconds to 1 min) which might delay the definitive step of ventilation for resuscitation of such babies that can potentially affect the outcome adversely.The utility or futility of endotracheal suction in preventing MAS in depressed meconium stained neonates has not been systematically studied and there is inadequate information in literature in favor or against this practice.Thus this study is an attempt to evaluate the effect of endotracheal suction on the occurrence of MAS in depressed full term neonates born through meconium stained amniotic fluid (MSAF).
详细描述
Approximately 10-15% of deliveries are complicated by the passage of meconium around the time of delivery.An adverse intrauterine environment with resultant fetal asphyxia is proposed as the most common explanation for in-utero passage of meconium.
Aspiration of meconium into the tracheo-bronchial tree with the onset of respiration results in meconium aspiration syndrome (MAS). MAS is defined as respiratory distress in an infant born through MSAF with compatible chest x-ray findings whose symptoms cannot be otherwise explained.
Despite current interventions such as intubation and tracheal suction, it is estimated that 5-20 % of infants born through MSAF develop MAS. It represents a leading cause of perinatal morbidity. Approximately 50% of the infants with MAS require mechanical ventilation; 15%-30% develop pulmonary air leaks and 5%-12% die.
There are various proposed mechanisms by which meconium causes lung injury, some of the important ones being
- Mechanical obstruction of airways
- Chemical pneumonitis
- Vasoconstriction of pulmonary vessels
- Inactivation of surfactant
- Activation of compliment
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestation age > 37 weeks
- •Cephalic Presentation
- •Singleton pregnancy
- •Presence of meconium stained amniotic fluid
- •Nonvigorous at birth
排除标准
- •Major congenital malformations
- •Refusal of consent
结局指标
主要结局
Incidence of MAS and death due to all cause
时间窗: till discharge or death up to 6 weeks of life
MAS is defined as meconium staining of liquor or staining of nails or umbilical cord or skin along with presence of any one of the following: * Respiratory distress within one hour of birth OR * Radiological evidence of aspiration pneumonitis (atelectasis and/or hyperinflation)
次要结局
- Duration of oxygen therapy(till discharge or death up to 6 weeks of life)
- Duration and severity of respiratory distress by Downe's scoring(till discharge or death up to 6 weeks of life)
- Need for and duration of Mechanical ventilation in hours(Till discharge or death up to 6 weeks of life)
- HIE(hypoxic ischemic encephalopathy) staging(During the first two weeks of life)
- Incidence of complications(till death or discharge up to 6 weeks of life)
- Duration of hospital stay(till death or discharge up to 6 weeks of life)
研究者
Sushma Nangia, M.D.
Professor of Pediatrics
Lady Hardinge Medical College