Comparison of two durations of caffeine therapy on clinically significant apnea - A randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Proportion of babies having clinically significant apnea from randomization till transfer to room in each of the two groups.
研究概览
简要总结
This is a Prospective,Randomized Controlled Trial to compare the differences in proportion of infants having clinically significant apnea when caffeine therapy is discontinued after the preterm infant has attained 7 apnea free days ( group 1 ) vs continuing caffeine till 34 weeks postmenstrual age ( group 2). The study is being conducted in a level IIIB 25 bedded referral Neonatal Intensive Care Unit for a period of 2 years (Augest 2015 to July 2017).174 preterm infants on caffeine therapy with birth gestation between 26-32 weeks is included in the study. The primary outcome is proportion of babies having clinically significant apnea from randomization till transfer to room in each of group 1 and group 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Day(s) 至 28.00 Day(s)（—）
- 性别
- All
入选标准
- •All babies with birth gestation between 26 – 32 weeks, on caffeine therapy.
- •Indications for caffeine therapy: 1)As treatment for apnea of prematurity.
- •Prophylactic caffeine therapy in extremely low birth weight infants (birth weight below 1000 g) to avoid intubation and mechanical ventilation, or to enhance extubation.
- •Periextubation caffeine for infants less than 32 weeks and those intubated for RDS.
排除标准
- •â—Major congenital anomalies â—Grade 111 or 1V Intraventricular Hemorrhage (IVH).
- •â—On drugs that can cause central nervous system depression – morphine, midazolam, antiepileptic drugs (AED).
结局指标
主要结局
Proportion of babies having clinically significant apnea from randomization till transfer to room in each of the two groups.
时间窗: till rooming in.
次要结局
- Gestation specific day of recurrence of apnea from the day caffeine is stopped.
- Recurrence risk of apnea in subgroup of babies with minimal vs moderate to severe respiratory illness after birth(till rooming in.)
- Proportion of babies requiring interventions for apnea of prematurity , after excluding those with apnea secondary to new sepsis, primary pulmonary pathology (pneumthorax, collapse, pulmonary hemorrhage, pneumonia), anemia, hyponatremia, preterm brain injury (USG cranium / MRI – PVL stage 2 or more), GERD requiring therapy, upper airway problems requiring intervention, inborn errors of metabolism(till rooming in)
- EUGR (extrauterine growth retardation, Z from birth weight) on gender specific Fentons chart(at discharge)
- NEC/feed intolerance / tachycardia requiring decrease in caffeine dose(till rooming in)
- Oxygen dependency at postnatal day 28(28 days postnatal age)
- Abnormal USG cranium at 36-40 weeks
- All cause mortality during initial hospitalization(during hospital stay)
- Neurological Outcome at discharge assessed by Hammersmith examination(at discharge)
- ROP requiring laser treatment