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临床试验/CTRI/2025/12/099879
CTRI/2025/12/099879尚未招募不适用

Efficacy of Surfactant administration through Laryngeal Mask Airway (LMA) vs Less Invasive Surfactant Administration (LISA) in Preterm Neonates.

Pt Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Need for mechanical ventilation within 72 hours of surfactant administration

研究概览

简要总结

Eligible preterm neonates will be randomized in two groups. Group 1 (LMA group) and Group 2 (LISA group) and allocation ratio will be kept in 1 is to 1 ratio. Before the procedure interface will be changed to snugly fitting nasal cannula for delivering Non- Invasive Positive Pressure Ventilation (NIPPV) and will be reinstituted prior NIPPV after completion of the procedure. Surfactant will be administered through LMA in group 1 and through LISA in group 2. Both groups will have the same pre-specified criteria for surfactant re-dosing. If FiO2 equal to 20 percent higher than the baseline FiO2 within 8 h of therapy, surfactant will be re-dosed in either group, after excluding other causes of respiratory insufficiency. Beyond 8 h of the First dose, re-dosing will be considered if FiO2 greater than or equal to 0.60 or if FiO2 greater than or equal to 0.30, associated with worsening clinical signs of RDS. Neonates will be then observed for parameters like need for Mechanical Ventilation, Transient Bradycardia or Desaturation, IVH, NEC, Duration of Hospital stay and Mortality and the data will be recorded. Neonates will be followed up till their discharge from the hospital or till the secondary outcome. All data will be analysed using suitable statistical methods and p-value less than 0.05 will be considered the cut off value for significance in all analysis involved.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • Preterm infants between 30 to 34+6 weeks of gestation who develop mild to moderate respiratory distress between 4 to 48 hours of birth, requiring FiO2 0.3 to 0.60 to maintain SpO2 88 to 95 percent on nCPAP of 5to 6 cm of H2O and signed the parental consent.

排除标准

  • Previous intubation or Surfactant therapy.
  • Apgar score of greater than or equal to 3 at 5 min.
  • Pneumothorax prior to enrolment.
  • Severe RDS indicated by FiO2 greater than 0.
  • Newborns with major congenital anomalies (major malformations involving craniofacial, Cardiac or thoracic).
  • Newborns with perinatal asphyxia.

结局指标

主要结局

Need for mechanical ventilation within 72 hours of surfactant administration

时间窗: Within 3 Days

次要结局

  • Duration of hospital stay(Intraventricular haemorrhage (IVH))

研究者

发起方
Pt Bhagwat Dayal Sharma Institute of Health Sciences Rohtak Haryana
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Kapil Bhalla

Pt. Bhagwat Dayal Sharma Institute of health sciences.

研究点 (1)

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