Comparison of the Silverman-Andersen Score and the Downes Score in Assessing the Severity of Respiratory Distress and Predicting Noninvasive Ventilation Failure in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- To determine the predictive role of the Downes score for noninvasive ventilation failure at 24 and 72 hours of life
研究概览
简要总结
This study aimed to compare the Silverman-Andersen score and the Downes score in predicting noninvasive ventilation (NIPPV) failure in preterm and term infants who received NIPPV support due to postnatal respiratory distress, as well as to evaluate the agreement of these scoring systems with other methods used to assess the severity of respiratory distress.
The present study was designed as a prospective, multicenter, observational study conducted with neonates undergoing noninvasive ventilation.
详细描述
The present study was designed as a prospective, multicenter, observational study conducted with neonates undergoing noninvasive ventilation. The study will be conducted in 4 centers (Mugla Training and Research Hospital, Mugla, Turkey; Akdeniz University School of Medicine, Antalya, Turkey; Antalya Training and Research Hospital, Antalya, Turkey; Sanliurfa Training and Research Hospital, Sanliurfa, Turkey). Written informed consent will be obtained from the parents of each neonatal patient prior to enrollment in the study.
Participants:
Preterm infants born at >28 weeks of gestation and term infants born at ≥37 weeks of gestation who developed respiratory distress within the first 6 hours after birth (defined as the presence of at least two of the following: respiratory rate ≥60/min, subcostal/intercostal retractions, and grunting), whose respiratory distress persisted for more than 6 hours, who were within the first 12 hours of life, had a Silverman-Andersen score ≥3, and received NIPPV support will be included in the study (1).
Infants with major congenital malformations, airway or pulmonary anomalies, cardiovascular or respiratory instability due to sepsis, cyanotic congenital heart disease, severe intraventricular hemorrhage, contraindications for NIPPV therapy (such as congenital nasal anomalies, congenital diaphragmatic hernia, or abdominal wall defects), those who required intubation or chest compressions in the delivery room, required intubation within the first hour of life, died within the first 24 hours of life, were born at ≤28 weeks of gestation, or were diagnosed with air leak syndrome (pneumothorax) prior to initiation of NIPPV therapy will be excluded from the study.
Respiratory support protocol Infants ≥34 weeks of gestation with respiratory distress within the first 6 hours of life will be observed for 2 hours; if distress persists and the Silverman-Andersen score is ≥3, NIPPV will be initiated. Infants <34 weeks with respiratory distress and a Silverman-Andersen score ≥3 will be directly started on NIPPV. NIPPV is a routine, noninvasive respiratory support modality widely used in our unit and globally. Ventilatory support will be delivered via short binasal prongs using a mechanical ventilator.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Hours 至 12 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at >28 weeks of gestation or term infants born at ≥37 weeks of gestation.
- •Development of respiratory distress within the first 6 hours after birth, defined as the presence of at least two of the following: Respiratory rate ≥60/min, Subcostal/intercostal retractions, Grunting.
- •Persistence of respiratory distress for more than 6 hours.
- •Age within the first 12 hours of life.
- •Silverman-Andersen score ≥
- •Receiving NIPPV support.
排除标准
- •Major congenital malformations.
- •Airway or pulmonary anomalies.
- •Cardiovascular or respiratory instability due to sepsis.
- •Cyanotic congenital heart disease.
- •Severe intraventricular hemorrhage.
- •Contraindications for NIPPV therapy (e.g., congenital nasal anomalies, congenital diaphragmatic hernia, abdominal wall defects).
- •Requirement of intubation or chest compressions in the delivery room.
- •Requirement of intubation within the first hour of life.
- •Death within the first 24 hours of life.
- •Gestational age ≤28 weeks.
- •Diagnosis of air leak syndrome (pneumothorax) prior to initiation of NIPPV therapy.
结局指标
主要结局
To determine the predictive role of the Downes score for noninvasive ventilation failure at 24 and 72 hours of life
时间窗: 24 hours and 72 hours after birth
Noninvasive ventilation failure will be defined as the need for intubation in an infant receiving NIPPV. The Downes score will be assessed at 30 minutes after initiation of NIPPV therapy, and its predictive value for noninvasive ventilation failure will be evaluated at 24 and 72 hours of life. The Downes score evaluates cyanosis, respiratory rate, retractions, grunting, and air entry to the lungs on auscultation. Each parameter is scored between 0 and 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater severity of respiratory distress (5).
To determine the predictive role of the Silverman-Andersen score for noninvasive ventilation failure at 24 and 72 hours of life.
时间窗: 24 hours and 72 hours after birth
Noninvasive ventilation failure will be defined as the need for intubation in an infant receiving NIPPV. The Silverman-Andersen score will be assessed at 30 minutes after initiation of NIPPV therapy, and its predictive value for noninvasive ventilation failure will be evaluated at 24 and 72 hours of life. The Silverman-Andersen score assesses upper chest movement, intercostal retractions, subxiphoid retractions, nasal flaring, and air entry to the lungs on auscultation. Each parameter is scored between 0 and 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater severity of respiratory distress (5).
次要结局
- Agreement of the Respiratory Severity Score with the Silverman-Andersen score and Downes score(30 minutes after the initiation of NIPPV therapy)
- Agreement of the oxygen saturation index (OSI) with the Silverman-Andersen score and Downes score(30 minutes after the initiation of NIPPV therapy)
- Agreement of the blood gas pH and PaCO₂ with the Silverman-Andersen score and Downes score(30 minutes after the initiation of NIPPV therapy)
- Agreement of the SpO₂/FiO₂ ratio with the Silverman-Andersen score and Downes score(30 minutes after the initiation of NIPPV therapy)
- The predictive value of Silverman-Andersen score and Downes score for surfactant requirement in infants born before 34 weeks of gestation(At 48 hours following the initiation of NIPPV therapy)
- The predictive value of Silverman-Andersen score and Downes score for mortality ,(Prior to discharge)
研究者
Ozkan Ilhan
Associate Professor
Muğla Sıtkı Koçman University