Swaddle Vs Swaddle with oral melatonin for MRI in neonates and infants- A prospective randomised control study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Was imaging successful without interruptions in first attempt? (Yes/No)
研究概览
简要总结
MRI(Magnetic resonance imaging) in neonates and infants requires immobility, which most often requires administration of anaesthesia with associated risks of neurotoxicity and airway manipulations. Swaddling technique provides immobility to some extent and which can be further improved by oral melatonin producing natural sleep. The patients will be prospectively enrolled and will be randomised to one o0f the 2 groups- Group M and Group S. All neonates/ infants are sleep and feed deprived for 4 hours prior to the imaging. In Group M the subject will receive 1ml/kg of melatonin (3mg tablet pulverized and added to 3 ml of 25 % dextrose) and in Group S the subject receives 1ml/kg of 25 % Dextrose 60 minutes prior the scan. Both groups receive breast feed 30 minutes prior and wrapped in a warm mattress and ears are plugged. Intravenous line tubing extension and pulseoximeter probe cable are made accessible after wrapping. Preprocedural(T1) and post procedural(T2) Heart rate, oxygen saturation and respiratory rate are noted.
The subject Age, Post conceptional age,Diagnosis, MRI region scanned, Total MRI sequence time, Total time spent in Scan room, whether contrast was administered, Did the child move?, was the scan done with/ without interruption? Quality of image as reported by radiologist( graded 1-good; 2-compromised but reportable; 3-poor and not reportable. Any adverse events like apnea, aspiration, desaturation will be noted. The subject is awakened once the MRI is done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 6.00 Month(s)(—)
- 性别
- All
入选标准
- •weight more than 1.5 kilogram Term and Ex-preterm infants with post conceptional age more than 37 weeks.
排除标准
- •history of apneic episodes history of laryngomalacia or tracheomalacia hemodynamically unstable requirement of oxygen or ventilatory support MRCP.
结局指标
主要结局
Was imaging successful without interruptions in first attempt? (Yes/No)
时间窗: T1- baseline | T2- At end of procedure( 1 hour)
次要结局
- Was imaging successful with interruptions? (Yes/No)(T1- Baseline)
- quality of imaging (grading 1-3)(T2- At end of procedure(1 hour))
- Adverse events during or after procedure(T2- At end of procedure(1 hour))
研究者
Dr Raylene Dias
Seth GS Medical college and KEM hospital
