An interventional study of Intervention Name: Poractant alfa (surfactant) administered by the INSURE method in Preterm Infants, Neonatal Respiratory Distress Syndrome and Need for Mechanical Ventilation, sponsored by Fatima Jinnah Medical University. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Fatima Jinnah Medical University · Not applicable, Interventional, and Treatment
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**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.
123 studies on the registry are indexed under Respiratory Distress Syndrome, Newborn; 24 are open to participants now.
This study's enrollment of 90 is close to the median of 90 across 93 interventional studies indexed under Respiratory Distress Syndrome, Newborn.
Browse Respiratory Distress Syndrome, Newborn studies →Fatima Jinnah Medical University is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Intervention Name: Poractant alfa (surfactant) administered by the INSURE method
Active Comparator - INSURE
Drug: 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.
Need for Mechanical Ventilation
Proportion of preterm infants with respiratory distress syndrome requiring mechanical ventilation after surfactant administration, comparing the Less Invasive Surfactant Administration (LISA) group with the conventional INSURE group. Mechanical ventilation will be required if the infant needs an FiO₂ greater than 0.40 after surfactant administration.
Time frame: Within 3 hours after surfactant administration
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2023 to primary completion in Jun 2024, 13 months.
Of 35 non-industry interventional studies with no phase under Respiratory Distress Syndrome, Newborn, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 40. This study's 13 months is below that.
Counting every sponsor, half of 35 studies reached it within 23 months; a quarter within 13 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome, Newborn →
Fatima Jinnah Medical University