Inhaled Corticosteroids for the Treatment of Transient Tachypnea of the Newborn in Infants Born at >34 Weeks Gestation: A Prospective, Randomized, Double Blind, Placebo Controlled Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Assessment of respiratory distress
研究概览
简要总结
Transient Tachypnea of the Newborn (TTN) is a common respiratory disorder affecting late preterm and term babies caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid.
The investigators hypothesize that ENAC expression will be up-regulated as a result of administration of corticosteroids. This effect will lead to enhanced absorption of fetal lung fluid finally treating TTN. The aim of our study will be to evaluate whether inhaled corticosteroids reduce respiratory distress and morbidity in late preterm and term neonates presenting with TTN.
详细描述
The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Hours 至 6 Hours（Child）
- 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 TTN
- •Parents signed informed consent
排除标准
- •Meconium aspiration syndrome
- •Respiratory distress syndrome
- •Congenital heart disease
- •Non respiratory disorders causing tachypnea
研究组 & 干预措施
Control
Inhaled NS 0.9%
干预措施: placebo (Drug)
结局指标
主要结局
Assessment of respiratory distress
时间窗: 48 hours
The primary outcome measure will be the assessment of respiratory distress reflected by TTN clinical score in neonates presenting with TTN and treated with inhaled corticosteroids compared to placebo at 12, 24 and 48 hours after the first dose of inhaled study medication.
次要结局
- The secondary outcome will be the assessment of morbidity associated with TTN(An average time period expected to be 5 days, according to the duration of hospital stay)
研究者
Kugelman Amir
Head, Pediatric Pulmonary Unit
Bnai Zion Medical Center