Preterm InfantsNCT07910539
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
A study testing Intervention Name: Poractant alfa (surfactant) administered by the INSURE method in people with Preterm Infants and Neonatal Respiratory Distress Syndrome, run by Fatima Jinnah Medical University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Infants, Neonatal Respiratory Distress Syndrome, Need for Mechanical Ventilation
- What is being tested?
- Intervention Name: Poractant alfa (surfactant) administered by the INSURE method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 25 May 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Preterm infants born before 35 weeks of gestation.
- Infants diagnosed with neonatal respiratory distress syndrome based on clinical and radiological criteria.
- Infants whose parents provide written informed consent.
Who cannot join
- Infants who required intubation during resuscitation after birth.
- Infants whose parents do not provide written informed consent.
- Infants born with congenital malformations or defects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of LISA and INSURE Methods for Surfactant Administration in Preterm Infants With Respiratory Distress Syndrome
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.
- Being tested
- Intervention Name: Poractant alfa (surfactant) administered by the INSURE method
- Keywords
- Respiratory Distress Syndrome, Preterm Infants, Neonatal Respiratory Care,, Surfactant Administration,, Less Invasive Surfactant Administration (LISA),, INSURE Method
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention Name: Poractant alfa (surfactant) administered by the INSURE methodDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - LISA | Experimental | Not described Receives: Drug: Intervention Name: Poractant alfa (surfactant) administered by the INSURE method |
| Active Comparator - INSURE | Active comparator | Active Comparator - INSURE Receives: Drug: Intervention Name: Poractant alfa (surfactant) administered by the INSURE method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 hours after surfactant administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start25 May 2023
- Primary completion25 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Humaira Waseem, Fatima Jinnah Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910539
- Sponsor's protocol ID
- CPSP / REU / P ED-2o 20-059'5
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of LISA and INSURE Methods for Surfactant Administration in Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07910539
- Acronym / sponsor ID
- CPSP / REU / P ED-2o 20-059'5
- Keywords
- Respiratory Distress Syndrome, Preterm Infants, Neonatal Respiratory Care,, Surfactant Administration,, Less Invasive Surfactant Administration (LISA),, INSURE Method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Fatima Jinnah Medical UniversityUniversity, hospital or other
- Study start
- 25 May 2023 (actual)
- Primary completion
- 25 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - LISA | Experimental | Drug: Intervention Name: Poractant alfa (surfactant) administered by the INSURE method |
| Active Comparator - INSURE | Active comparator | Drug: Intervention Name: Poractant alfa (surfactant) administered by the INSURE methodActive Comparator - INSURE |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Preterm infants born before 35 weeks of gestation.
- Infants diagnosed with neonatal respiratory distress syndrome based on clinical and radiological criteria.
- Infants whose parents provide written informed consent.
Key exclusion criteria (3 listed)
- Infants who required intubation during resuscitation after birth.
- Infants whose parents do not provide written informed consent.
- Infants born with congenital malformations or defects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention Name: Poractant alfa (surfactant) administered by the INSURE methodSurfactant 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. | Drug | Active Comparator - INSURE, Experimental - LISA |
Primary outcome
Need for Mechanical Ventilation
Time frame: Within 3 hours after surfactant administration
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Name: Poractant alfa (surfactant) administered by the INSURE method in people with Preterm Infants and Neonatal Respiratory Distress Syndrome, run by Fatima Jinnah Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for Mechanical Ventilation (time frame: Within 3 hours after surfactant administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.