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Surfactant are alveolar surface reducing agents,used in preterm baby having lower pool surfactant i.e. respiratory distress syndrome. Sedation and pain reducing drug administration during surfactant therapy by less invasive technique will be assessed in this trial.

Not yet recruiting
Conditions
Respiratory distress syndrome of newborn,
Registration Number
CTRI/2022/03/041453
Lead Sponsor
IPGMER SSKM HOSPITAL
Brief Summary

For all nonemergent neonatal ventilation,premedicarion is considered mandatory.Awake laryngoscopy is known to be painful and associated with many adverse events.There is still no concensus on whether or not to use sedation during LISA.  With sedation LISA procedure become smooth and sucessful but it might compromise the infants respiratory drive which is a prerequisite for LISA. This study will therefore be conducted to determine the efeects of fentanyl on the requirement of mechanical ventilation in the 72hr following the procedure in infants with RDS.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
320
Inclusion Criteria
  • Preterm baby with gestational age between 28 to 34 weeks diagnosed with RDS will enroll in this study .
  • RDS will be diagnosed clinically initially and later confirm by chest X ray .
  • A written informed consent will be obtained from the parents of the baby for participation in the study.
Exclusion Criteria
  • Baby with major congenital anomaly .
  • Intubated at delivery room.
  • Alternative cause of respiratory distress.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome is the need for mechanical ventilation from the LISA procedure onwards up to 72 h of life.The primary outcome is the need for mechanical ventilation from the LISA procedure onwards up to 72 h of life.
Secondary Outcome Measures
NameTimeMethod
Number of laryngoscopy attempts during the procedureComplications occurring during and after the procedure SpO2 80 percentage hypotension with mean below gestational age bradycardia 100 bpm

Trial Locations

Locations (1)

evel III Neonatal Care Unit Department of Neonatology IPGMER SSKM HOSPITAL

🇮🇳

Kolkata, WEST BENGAL, India

evel III Neonatal Care Unit Department of Neonatology IPGMER SSKM HOSPITAL
🇮🇳Kolkata, WEST BENGAL, India
Dr Bijan Saha
Principal investigator
09051389120
bijansaha18@gmail.com

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