Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 主要终点
- Duration of oxygen support & O2 concentration until Downes' score less than 4
研究概览
简要总结
Inhaled Beta-2 Agonist Versus Epinephrine For Treatment of Transient Tachypnea of Newborn: Randomized controlled trial to assess:
详细描述
This is a randomized double-blind randomized controlled trial. It had been conducted at the Neonatal Intensive Care Unit (NICU) of Mansoura University Children's Hospital, Egypt Written informed consent had been taken from all parents whose infants were recruited in the study. The ethics committee of the faculty of medicine has approved the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Hour 至 6 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •babies with 35 weeks of gestation or more in the first 6 hours of life diagnosed with TTN according to the criteria of which are:
- •Tachypnea (respiratory rate exceeding 60 breaths/ min) within 6 hours after birth
- •Persistence of tachypnea for at least 12 hours
- •Mild cyanosis, nasal flaring, or retractions.
- •Chest radiograph indicating at least one of the following:
- •Prominent central vascular markings
- •Widened interlobar fissures
- •Symmetrical perihilar congestion
- •Hyperaeration is evidenced by flattening and depression of the diaphragmatic domes.
排除标准
- •Newborn infants with gestational age < 35 weeks
- •Meconium aspiration
- •Respiratory distress syndrome
- •Pneumonia
- •Congenital heart diseases including persistent pulmonary hypertension of the neworn (PPHN)
- •Sepsis or suspected sepsis
- •Polycythemia
- •Newborn infants with congenital malformations and chromosomal anomalies
- •Newborn infants with ventilatory support.
- •Newborn infants with arrhythmia
研究组 & 干预措施
Salbutamol Group
included babies who had received nebulized B2 agonist salbutamol (0.15 mg/kg) + 4ml normal saline
干预措施: Salbutamol (Drug)
Epinephrine Group
included babies who had received nebulized epinephrine (0, 05 ml/Kg) + 4ml normal saline
干预措施: Epinephrine Inhalation Solution (Drug)
Saline Group
include babies who had received nebulized 0.9% saline
干预措施: Saline Inhalants (Drug)
结局指标
主要结局
Duration of oxygen support & O2 concentration until Downes' score less than 4
时间窗: through study completion, about 1 year
次要结局
- Length of hospital stay until Downes' score less than 4(through study completion, about 1 year)
- Effect of intervention on blood sugar (mg/dl)(within 12 hours after intervention)
- Type of respiratory support (oxygen delivery and oxygen concentration)(within 12 hours after intervention)
研究者
Ahmed Noaman
Lecturer
Mansoura University Children Hospital