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Comparison of the Need Of Mechanical Ventilation Between Less Invasive Surfactant Administration (LISA) and Conventional INSURE (Intubation-Surfactant Administration-Extubation) Methods in Spontaneously Breathing Preterm Infants With Respiratory Distress Syndrome
Sponsor: Fatima Jinnah Medical University
Summary
\*\*Brief Summary of the Study\*\* This randomized controlled trial aims to compare the need for mechanical ventilation between Less Invasive Surfactant Administration (LISA) and the conventional INSURE (Intubation, Surfactant Administration, and Extubation) method in spontaneously breathing preterm infants with respiratory distress syndrome. The study will be conducted in the Department of Neonatology, Sir Ganga Ram Hospital, Lahore, Pakistan, with a total sample size of 90 preterm infants born before 35 weeks of gestation. Participants will be allocated to either the LISA group or the INSURE group, with 45 infants in each group. The primary outcome will be the need for mechanical ventilation following surfactant administration, assessed within three hours of treatment. Data will be analyzed using SPSS version 25.0, with the chi-square test used to compare the need for mechanical ventilation between the two groups. The findings are expected to help identify the more effective surfactant administration method in reducing the need for mechanical ventilation in preterm infants with respiratory distress syndrome.
Official title: Comparison of LISA and INSURE Methods for Surfactant Administration in Preterm Infants With Respiratory Distress Syndrome
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-05-25
Completion Date
2024-06-30
Last Updated
2026-11-02
Healthy Volunteers
No
Interventions
Intervention Name: Poractant alfa (surfactant) administered by the INSURE method
Surfactant will be administered at a dose of 100 mg/kg using a 6 Fr nasogastric tube. Under direct laryngoscopic visualization, the catheter will be passed 1-2 cm beyond the vocal cords. Surfactant will be administered in small aliquots over 1-3 minutes while the infant continues spontaneous breathing on nasal CPAP. Nasal CPAP will be maintained during and after the procedure. The infant will be intubated and surfactant will be administered through an endotracheal tube at a dose of 100 mg/kg in 2-3 aliquots while receiving positive-pressure ventilation through a T-piece circuit. After 15-20 minutes of positive-pressure ventilation, the endotracheal tube will be removed and the infant will be placed on nasal CPAP.
Locations (1)
Fatima Jinnah Medical University
Lahore, Pakistan