Inhaled Budesonide in Transient Tachypnea of the Newborn: A Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Assessment of respiratory distress
研究概览
简要总结
Background: Transient tachypnea of the newborn (TTN) caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid and is a common cause of admission of late preterm and full-term infants to neonatal intensive care units. Infant born by C-section and those with perinatal asphyxia, umbilical cord prolapse or certain maternal condition (asthma, diabetes, or analgesia) are more prone to develop TTN. Conventional treatment involves appropriate oxygen administration and continuous positive airway pressure in some cases. Hastening the clearance of lung liquid should shorten the duration of the symptoms and reduce complications.
Objectives: This study aims to determine the effectiveness of inhaled budesonide in the treatment of this disorder through determining whether it reduces the duration of oxygen therapy and respiratory symptoms and shortens hospital stay in term infants with transient tachypnea of the newborn
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 34 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Late preterm and term infants (post-menstrual age ≥ 34 weeks) delivered by Cesarean section or vaginal delivery
- •Diagnosis of transient tachypnea of the newborn
- •The need for Continuous positive airway pressure (CPAP) >6 hours to obtain the oxygen saturation >92%
排除标准
- •Meconium aspiration syndrome;
- •Respiratory distress syndrome
- •Congenital heart Disease
- •Non respiratory disorders causing tachypnea (polycythemia or hypoglycemia) resolving with treatment of the disorder
- •Pneumonia by chest x-ray
- •Suspected sepsis/bacteremia
- •Prenatal steroids
结局指标
主要结局
Assessment of respiratory distress
时间窗: within 48 hours
Transient tachypnea of the newborn clinical score
次要结局
- Assessment of time to spontaneous breathing(with 48 hours)
研究者
Dr. Sirin Mneimneh
Pediatrician
Makassed General Hospital