Extreme PrematurityDRLISANCT04715373
LISA in the Delivery Room for Extremely Preterm Infants
A study testing LISA in people with Extreme Prematurity and Respiratory Distress Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of LISA used in the delivery room (DR) in decreasing the intubation rates in preterm infants at 22-25 weeks gestational age (GA), during first 72 hours compared to the standard approach of stabilization on nasal CPAP in the DR and administering surfactant in the… Read more about this study
- Who is it for?
- Ages 5 to 20 minutes
- Conditions the study is for
- Extreme Prematurity, Respiratory Distress Syndrome
- What is being tested?
- LISA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2021to 8 Apr 2025
- 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 5 to 20 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born 22 -25 weeks GA
- Resuscitated without requiring intubation and maintaining HR >100, and spontaneous respiratory effort on CPAP 5-7 cm H2O)
Who cannot join
- Major congenital anomalies
- Infants receiving only comfort care
- Mothers with impaired decision making capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Less Invasive Administration of Surfactant in the Delivery Room for Extremely Preterm Infants: A Randomized Control Trial
The purpose of this study is to evaluate the effect of LISA used in the delivery room (DR) in decreasing the intubation rates in preterm infants at 22-25 weeks gestational age (GA), during first 72 hours compared to the standard approach of stabilization on nasal CPAP in the DR and administering surfactant in the NICU.
Infants in both groups will be resuscitated per NRP algorithm. Infants who maintain a stable HR and respiratory effort on CPAP will qualify for the intervention. Infants in Group 1 (Intervention arm) will receive LISA in DR. CPAP will be titrated between 5-8 cm H20 after LISA. Infants in Group 2 (Control arm) will be transferred to NICU on CPAP. The CPAP level will be increased stepwise every 30 minutes to 7 cm H2O if FiO2 ≥0.3. Infants requiring CPAP 7 at FiO2 ≥0.3 will receive LISA. CPAP will be titrated between 5-8 cm H20 after LISA.
Read more
Infants in both arms requiring CPAP 7 and FiO2 >0.8 at 20 MOL in the delivery room will be intubated in DR. Any infant with a heart rate not responding with appropriate PPV will be intubated in the DR. CXR will be obtain on admission and umbilical lines will be placed. Infants in both arm who require FiO2 ≥0.6 for ≥1 hour, apnea requiring stimulation 3 times within one hour or ≥6 over 6 hour period, any apnea requiring PPV, or CO2 >0.65 in two consecutive blood gases drawn over two hours will be considered as reasons for intubation after LISA.
Primary outcome is the need for MV within 72 hours of life, secondary outcome includes need for MV during first week of life and during hospital stay, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), need for treatment of patent ductus arteriosus (PDA), composite death or BPD and mortality. This is a feasibility trial with the intention to enroll 30 infants in each arm of the study over three years.
Read the detailed description
This is a single center, unblinded, randomized control, feasibility trial to evaluate the use of LISA in the DR for extremely preterm infants born 22-25 weeks GA who were successfully resuscitated without being intubated. The study team will approach a mother who is at risk of delivering an infant between 22-25 week GA for consent to be included in the study. Infants will be resuscitated according to NRP algorithm. Infants who are successfully resuscitated without requiring intubation and mechanical ventilation (HR >100, regular spontaneous respiratory effort, able to maintain oxygenation per NRP target saturation goal) are eligible for enrollment. Randomization will be achieved by opening an opaque envelope.
- Intervention arm (DR-LISA): Infants with a stable heart rate and spontaneous respiratory effort on CPAP are eligible for surfactant therapy. A LISA catheter will be prepared for use prior to the birth of the infant. Surfactant will be drawn into a syringe soon after the initial stabilization. A trained physician will perform LISA. The infant will be maintained on CPAP by prongs during the procedure. PPV will be provided if needed after the procedure. The infant will be monitored in the DR for stable HR, respiration and SpO2 prior to being moved to a transporter. Infants requiring FiO2 >0.8 on CPAP 8 cm H2O to maintain SpO2 88-94% by 20 minutes of life will be intubated prior to transport. After admission to NICU, CPAP level will be titrated between 5-8 cm H20 based on FiO2 threshold ≥0.3
- Control arm: Infants will be resuscitated per NRP guidelines. Infant with stable HR and respiratory effort will be changed to binasal prongs and transported to NICU on CPAP. CPAP level be titrated between 5- 7 cm H2O in the DR. Infants requiring FiO2 >0.8 to maintain SpO2 88-94% by 20 minutes of life will be intubated in DR. After admission to NICU, CPAP will be escalated every 30 minutes up to a maximum level of 7 cm H2O at which point infant would qualify for LISA if the FiO2 requirement is ≥0.3. CPAP level will be titrated between 5-8 cm H20 based on FiO2 threshold ≥0.3. Infants in both groups who require FiO2 ≥0.6 for ≥1 hour, apnea requiring stimulation 3 times within one hour or ≥6 over 6 hour period, any apnea requiring PPV, or CO2 >0.65 in two consecutive blood gases drawn over two hours will be considered as reasons for intubation after LISA.
Repeat doses of surfactant will be administered every 12 hours for FiO2 ≥0.4 up to a maximum of three doses.
- Conditions
- Extreme Prematurity, Respiratory Distress Syndrome
- Being tested
- LISA
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LISAProcedure or surgery
LISA administered in the DR after initial resuscitation or in the NICU after stepwise escalation of CPAP based on FiO2 ≥0.3. While maintaining infant on CPAP with binasal prongs/small nasal mask, a thin catheter (Hobart method) is inserted below the vocal cord using direct laryngoscopy. Poractant alfa (200mg/kg) is administered slowly over 2-3 minutes. Catheter is then withdrawn and infant is maintained on CPAP
| Study group | Role | What they receive |
|---|---|---|
| DR-LISA | Experimental | Experimental:
Group 1: (Intervention Arm) Infants will be resuscitated per NRP guidelines. Infant with stable HR and respiratory effort will be changed to binasal prongs. A trained physician will perform LISA. Infant will be maintained on CPAP by prongs during the procedure. . PPV will be provided if needed after the procedure. Infants requiring FiO2 >0.8 on CPAP 8 cm H2O to maintain SpO2 88-94% by 20 minutes of life will be intubated prior to transport. After admission to the NICU, CPAP will be titrated 5-8 cm H2O. Receives: Procedure: LISA |
| NICU-LISA | Active comparator | Group 2: Control Arm Infants will be resuscitated per NRP guidelines. Infant with stable HR and respiratory effort will be changed to binasal prongs and transported to NICU on CPAP. After admission to NICU, CPAP will be escalated every 30 minutes up to a maximum level of 7 cm H2O at which point infant would qualify for LISA if the FiO2 requirement is ≥0.3. Infants requiring FiO2 >0.8 to maintain SpO2 88-94% by 20 minutes of life will be intubated in the DR. Receives: Procedure: LISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for intubation and/any mechanical ventilation
Any Infant randomized to the study requiring intubation and/mechanical ventilation
Measured: within 72 hours of life
Secondary outcomes (10)
Need for mechanical ventilation within 7 days of life
Any Infant randomized to the study requiring intubation and/mechanical ventilation
Measured: Within 7 days of life.
Mechanical Ventilation
Any infant requiring MV
Measured: Until hospital discharge or 6 months of life
High Frequency Ventilation
Any infant requiring high frequency ventilation. This outcome will not be analyzed because of a protocol amendment.
Measured: Until hospital discharge or 6 month of life
Mechanical ventilator days
Infant requiring MV for longer than 12 hours in a day
Measured: Until hospital discharge or 6 months of life
Bronchopulmonary dysplasia
Infant requiring supplemental oxygen at 36 weeks PMA
Measured: Until hospital discharge or 6 months of life
Severe intraventricular hemorrhage
Grade 3 or 4 intraventricular hemorrhage
Measured: Until hospital discharge or 6 months of life
Pneumothorax
Radiographic evidence of pneumothorax
Measured: Until hospital discharge or 6 months of life
Desaturation (SpO2 <80) and Bradycardia (HR <100) events
Any desaturation and bradycardia event lasting >10 seconds during LISA procedure
Measured: During the first 72 hours
Proportion of infants requiring >1 LISA attempt
Any direct laryngoscopy attempt
Measured: During the first 72 hours of life
Death or BPD
Composite outcome of death or BPD
Measured: at 36 weeks of GA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start22 Jun 2021
- Primary completion10 Dec 2024
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Extreme PrematurityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chiesi USA, Inc.
- Responsible party
- Principal investigator, Venkat Kakkilaya, University of Texas Southwestern Medical Center
- Investigators
- Venkatakrishna Kakkilaya, MBBS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715373
- Sponsor's protocol ID
- STU-2020-0926
- Acronym
- DRLISA
- Status last verified
- Oct 2026
- First submitted
- 13 Jan 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beijers RJ, Alonso-Fernandez S, Soll RF, Rojas-Reyes MX; supported by the Cochrane Neonatal Group. Prophylactic versus selective use of surfactant for preventing morbidity and mortality in preterm infants at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2026 Jul 22;7(7):CD000510. doi: 10.1002/14651858.CD000510.pub3.
PubMed 42483935
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Less Invasive Administration of Surfactant in the Delivery Room for Extremely Preterm Infants: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04715373
- Acronym / sponsor ID
- DRLISA / STU-2020-0926
- Conditions
- Extreme Prematurity, Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Chiesi USA, Inc.
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 20 Jan 2021 (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.
The purpose of this study is to evaluate the effect of LISA used in the delivery room (DR) in decreasing the intubation rates in preterm infants at 22-25 weeks gestational age (GA), during first 72 hours compared to the standard approach of stabilization on nasal CPAP in the DR and administering surfactant in the NICU.
Infants in both groups will be resuscitated per NRP algorithm. Infants who maintain a stable HR and respiratory effort on CPAP will qualify for the intervention. Infants in Group 1 (Intervention arm) will receive LISA in DR. CPAP will be titrated between 5-8 cm H20 after LISA. Infants in Group 2 (Control arm) will be transferred to NICU on CPAP. The CPAP level will be increased stepwise every 30 minutes to 7 cm H2O if FiO2 ≥0.3. Infants requiring CPAP 7 at FiO2 ≥0.3 will receive LISA. CPAP will be titrated between 5-8 cm H20 after LISA.
Infants in both arms requiring CPAP 7 and FiO2 >0.8 at 20 MOL in the delivery room will be intubated in DR. Any infant with a heart rate not responding with appropriate PPV will be intubated in the DR. CXR will be obtain on admission and umbilical lines will be placed. Infants in both arm who require FiO2 ≥0.6 for ≥1 hour, apnea requiring stimulation 3 times within one hour or ≥6 over 6 hour period, any apnea requiring PPV, or CO2 >0.65 in two consecutive blood gases drawn over two hours will be considered as reasons for intubation after LISA.
Primary outcome is the need for MV within 72 hours of life, secondary outcome includes need for MV during first week of life and during hospital stay, bronchopulmonary dysplasia (BPD), intraventricular hemorrhage (IVH), necrotizing enterocolitis (NEC), spontaneous intestinal perforation (SIP), need for treatment of patent ductus arteriosus (PDA), composite death or BPD and mortality. This is a feasibility trial with the intention to enroll 30 infants in each arm of the study over three years.
Detailed description
This is a single center, unblinded, randomized control, feasibility trial to evaluate the use of LISA in the DR for extremely preterm infants born 22-25 weeks GA who were successfully resuscitated without being intubated. The study team will approach a mother who is at risk of delivering an infant between 22-25 week GA for consent to be included in the study. Infants will be resuscitated according to NRP algorithm. Infants who are successfully resuscitated without requiring intubation and mechanical ventilation (HR >100, regular spontaneous respiratory effort, able to maintain oxygenation per NRP target saturation goal) are eligible for enrollment. Randomization will be achieved by opening an opaque envelope.
- Intervention arm (DR-LISA): Infants with a stable heart rate and spontaneous respiratory effort on CPAP are eligible for surfactant therapy. A LISA catheter will be prepared for use prior to the birth of the infant. Surfactant will be drawn into a syringe soon after the initial stabilization. A trained physician will perform LISA. The infant will be maintained on CPAP by prongs during the procedure. PPV will be provided if needed after the procedure. The infant will be monitored in the DR for stable HR, respiration and SpO2 prior to being moved to a transporter. Infants requiring FiO2 >0.8 on CPAP 8 cm H2O to maintain SpO2 88-94% by 20 minutes of life will be intubated prior to transport. After admission to NICU, CPAP level will be titrated between 5-8 cm H20 based on FiO2 threshold ≥0.3
- Control arm: Infants will be resuscitated per NRP guidelines. Infant with stable HR and respiratory effort will be changed to binasal prongs and transported to NICU on CPAP. CPAP level be titrated between 5- 7 cm H2O in the DR. Infants requiring FiO2 >0.8 to maintain SpO2 88-94% by 20 minutes of life will be intubated in DR. After admission to NICU, CPAP will be escalated every 30 minutes up to a maximum level of 7 cm H2O at which point infant would qualify for LISA if the FiO2 requirement is ≥0.3. CPAP level will be titrated between 5-8 cm H20 based on FiO2 threshold ≥0.3. Infants in both groups who require FiO2 ≥0.6 for ≥1 hour, apnea requiring stimulation 3 times within one hour or ≥6 over 6 hour period, any apnea requiring PPV, or CO2 >0.65 in two consecutive blood gases drawn over two hours will be considered as reasons for intubation after LISA.
Repeat doses of surfactant will be administered every 12 hours for FiO2 ≥0.4 up to a maximum of three doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DR-LISA | Experimental | Procedure: LISAExperimental: Group 1: (Intervention Arm) Infants will be resuscitated per NRP guidelines. Infant with stable HR and respiratory effort will be changed to binasal prongs. A trained physician will perform LISA. Infant will be maintained on CPAP by prongs during the procedure. . PPV will be provided if needed after the procedure. Infants requiring FiO2 >0.8 on CPAP 8 cm H2O to maintain SpO2 88-94% by 20 minutes of life will be intubated prior to transport. After admission to the NICU, CPAP will be titrated 5-8 cm H2O. |
| NICU-LISA | Active comparator | Procedure: LISAGroup 2: Control Arm Infants will be resuscitated per NRP guidelines. Infant with stable HR and respiratory effort will be changed to binasal prongs and transported to NICU on CPAP. After admission to NICU, CPAP will be escalated every 30 minutes up to a maximum level of 7 cm H2O at which point infant would qualify for LISA if the FiO2 requirement is ≥0.3. Infants requiring FiO2 >0.8 to maintain SpO2 88-94% by 20 minutes of life will be intubated in the DR. |
Who may qualify
- Ages
- 5 to 20 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born 22 -25 weeks GA
- Resuscitated without requiring intubation and maintaining HR >100, and spontaneous respiratory effort on CPAP 5-7 cm H2O)
Key exclusion criteria (3 listed)
- Major congenital anomalies
- Infants receiving only comfort care
- Mothers with impaired decision making capacity
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 |
|---|---|---|
| LISALISA administered in the DR after initial resuscitation or in the NICU after stepwise escalation of CPAP based on FiO2 ≥0.3. While maintaining infant on CPAP with binasal prongs/small nasal mask, a thin catheter (Hobart method) is inserted below the vocal cord using direct laryngoscopy. Poractant alfa (200mg/kg) is administered slowly over 2-3 minutes. Catheter is then withdrawn and infant is maintained on CPAP | Procedure or surgery | DR-LISA, NICU-LISA |
Primary outcome
Need for intubation and/any mechanical ventilation
Time frame: within 72 hours of life
Any Infant randomized to the study requiring intubation and/mechanical ventilation
10 secondary outcomes
Need for mechanical ventilation within 7 days of life
Time frame: Within 7 days of life.
Mechanical Ventilation
Time frame: Until hospital discharge or 6 months of life
High Frequency Ventilation
Time frame: Until hospital discharge or 6 month of life
Mechanical ventilator days
Time frame: Until hospital discharge or 6 months of life
Bronchopulmonary dysplasia
Time frame: Until hospital discharge or 6 months of life
Severe intraventricular hemorrhage
Time frame: Until hospital discharge or 6 months of life
Pneumothorax
Time frame: Until hospital discharge or 6 months of life
Desaturation (SpO2 <80) and Bradycardia (HR <100) events
Time frame: During the first 72 hours
Proportion of infants requiring >1 LISA attempt
Time frame: During the first 72 hours of life
Death or BPD
Time frame: at 36 weeks of GA
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 9 Oct 2026.
- Derived from this study: PubMed 42483935Beijers RJ, Alonso-Fernandez S, Soll RF, Rojas-Reyes MX; supported by the Cochrane Neonatal Group. Prophylactic versus selective use of surfactant for preventing morbidity and mortality in preterm infants at risk of respiratory distress syndrome. Cochrane Database Syst Rev. 2026 Jul 22;7(7):CD000510. doi: 10.1002/14651858.CD000510.pub3.
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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.
Venkatakrishna Kakkilaya, MBBS principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LISA in people with Extreme Prematurity and Respiratory Distress Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 2 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 9 Oct 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 United States. 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 intubation and/any mechanical ventilation (time frame: within 72 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715373, which also lists 1 linked publication.
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 9 Oct 2026.