Respiratory Distress Syndrome (RDS)Phase 3LISPAPNCT02772081

A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration

A Phase 3 study testing LISA combination product (Curosurf+catheter CHF6440) and Curosurf through conventional administration (endotracheal tube) in people with Respiratory Distress Syndrome (RDS), run by Chiesi Farmaceutici S.p.A. at 26 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 30 minutes to 24 hours
Conditions the study is for: Respiratory Distress Syndrome (RDS)
What is being tested?: LISA combination product (Curosurf+catheter CHF6440) and Curosurf through conventional administration (endotracheal tube)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 26 sitesUnited States
Study dates: 18 May 2021to 13 Aug 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 30 minutes to 24 hours
All sexes
No healthy volunteers
Child

Who may be able to join

Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
Preterm neonates of either sex aged ≥30 minutes and <24 hours, spontaneously breathing and stabilized on non-invasive ventilation (NIV).
Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15 enrolled neonates in which the gestational age will be restricted to 27+0 weeks up to 28+6 weeks.
Clinical course consistent with RDS.
Fraction of inspired oxygen (FiO2) ≥0.30 to maintain preductal oxygen saturation (SpO2) between 88-95%.

Who cannot join

Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive
Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry
Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
Known genetic or chromosomal disorders, major congenital anomalies (congenital heart diseases, myelomeningocele etc)
Mothers with prolonged rupture of the membranes (> 21 days duration)
Presence of air leaks if identified and known prior to study entry

Show all 10Show fewer

Evidence of severe birth asphyxia (e.g. continued need for resuscitation at 10 minutes after birth, altered neurological state, or neonatal encephalopathy)
Neonatal seizures prior to study entry
Any condition that, in the opinion of the Investigator, would place the neonate at undue risk
Participation in another clinical trial of any medicinal product, placebo, experimental medical device, or biological substance conducted under the provisions of a protocol on the same therapeutic target.

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

Chiesi Clinical Trial Site 84012
Camden, New Jersey, 08103
Chiesi Clinical Trial Site 84015
Charlottesville, Virginia, 22908
Chiesi Clinical Trial Site 84025
Cincinnati, Ohio, 45229
Chiesi Clinical Trial Site 84013
Denver, Colorado, 80204
Chiesi Clinical Trial Site 84003
Evanston, Illinois, 60201
Chiesi Clinical Trial Site 84027
Greenville, North Carolina, 27858
Chiesi Clinical Trial Site 84020
Hershey, Pennsylvania, 17033
Chiesi Clinical Trial Site 84008
Lansing, Michigan, 48912
Chiesi Clinical Trial Site 84023
Lexington, Kentucky, 40506
Chiesi Clinical Trial Site 84029
Little Rock, Arkansas, 72205
Chiesi Clinical Trial Site 84001
Los Angeles, California, 90033
Chiesi Clinical Trial Site 84002
Los Angeles, California, 90033
Chiesi Clinical Trial Site 84011
Lubbock, Texas, 79410
Chiesi Clinical Trial Site 84024
Manhasset, New York, 11030
Chiesi Clinical Trial Site 84007
Nashville, Tennessee, 37212
Chiesi Clinical Trial Site 84026
New Britain, Connecticut, 06052
Chiesi Clinical Trial Site 84019
New Hyde Park, New York, 11040
Chiesi Clinical Trial Site 84017
Oklahoma City, Oklahoma, 73104
Chiesi Clinical Trial Site 84021
Peoria, Illinois, 61637
Chiesi Clinical Trial Site 84006
Plano, Texas, 75075
Chiesi Clinical Trial Site 84028
Springfield, Massachusetts, 01199
Chiesi Clinical Trial Site 84004
St Louis, Missouri, 63104
Chiesi Clinical Trial Site 84022
Temple, Texas, 76502
Chiesi Clinical Trial Site 84009
Valhalla, New York, 10595
Chiesi Clinical Trial Site 84010
Wilmington, North Carolina, 28401
Chiesi Clinical Trial Site 84005
Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates With Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (Poractant Alfa, CUROSURF®) Administration: A Less Invasive Method (LISA) During Non-invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation.

This study compared the administration of porcine surfactant (poractant alfa, Curosurf®) through a less invasive method (LISA), using a thin catheter, CHF 6440 (LISACATH®), during non-invasive ventilation (CPAP, NIPPV, BiPAP) with an approved conventional surfactant administration during invasive ventilation followed by rapid extubation in terms of short term and mid-term safety and efficacy in spontaneously breathing preterm neonates who have clinical signs of respiratory distress syndrome (RDS).

Read the detailed description

This study was an open-label, multicentre, randomized, controlled study of spontaneously breathing neonates with RDS. Neonates were evaluated according to the selection criteria and then randomized to surfactant treatment via LISA or standard administration procedure. The enrolment was staggered: the gestational age was restricted to 27+0 weeks up to 28+6 weeks for the first 15 neonates. Provided no safety concerns were raised, the enrolment was planned to be extended to the whole population (i.e. 25+0 weeks up to 28+6 weeks). Enrolled neonates were evaluated in a main phase of the trial until discharge or 40 weeks post-menstrual age (PMA), whichever came first. Their clinical status and neurodevelopment was to be assessed at 24-month corrected age as a separate stand-alone visit.

The Sponsor decided to terminate the study early, due to uncertain sufficient availability of the CHF 6440 catheter.

Conditions: Respiratory Distress Syndrome (RDS)
Being tested: LISA combination product (Curosurf+catheter CHF6440), Curosurf through conventional administration (endotracheal tube)
Keywords: Less Invasive Surfactant administration, LISPAP, Neonates, Newborns, Respiratory Distress Syndrome (RDS), CUROSURF®
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.

LISA combination product (Curosurf+catheter CHF6440)Combination product
Curosurf administration through brief insertion of a thin catheter into the trachea
Curosurf through conventional administration (endotracheal tube)Drug
Curosurf through conventional administration (endotracheal tube), followed by rapid extubation

Study groups in NCT02772081
Study group	Role	What they receive
Curosurf LISA	Experimental	Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Receives: Combination Product: LISA combination product (Curosurf+catheter CHF6440)
Curosurf Endotracheal Tube	Active comparator	Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed. Receives: Drug: Curosurf through conventional administration (endotracheal tube)

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment
Extent of exposure to study treatment is summarized by treatment group. Number of participants who received 1, 2, or 3 doses of treatment.
All neonates received the first administration of Curosurf® 200 mg/kg. In case of lack of efficacy or clinical deterioration, a second dose of Curosurf® 100 mg/kg was administered using the same technique as the first dose. Neonates could receive a third Curosurf® 100 mg/kg dose if needed, administered using a standard technique. Results are presented as the number of neonates who received 1, 2, or 3 doses of Curosurf®, administered.
Measured: First 72 hours of life.
Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube
Number of participants for whom the first attempt failed to insert the catheter/endotracheal tube and the percentage of neonates with first failed attempt, is presented by treatment group.
Measured: At first surfactant administration, up to Day 1.
Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization
Number of manoeuvres (attempts) discontinued, due to neonate's severe destabilization is presented by treatment group.
Measured: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion
Number of attempts required to achieve first successful insertion is presented by treatment group.
Measured: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Safety: Study Treatment Administration: Number of Device Misallocation for LISA Administration Group (Esophageal Insertion)
Number of device misallocation for LISA administration group (esophageal insertion).
Data was not collected from participants in the "Curosurf Endotracheal Tube" -- the control arm of the study, because it is not applicable.
Measured: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Safety: Study Treatment Administration: Duration of Surfactant Administration
Duration of surfactant administration is presented by treatment group.
Measured: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Safety: Study Treatment Administration: Duration of the Whole Procedure
Duration of the whole procedure (starting from the insertion of laryngoscope up to the removal of the catheter/ETT), is presented by treatment group.
Measured: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.

Secondary outcomes (16)

Efficacy: Duration of Oxygen Alone Supplementation and Any Non-Invasive Ventilation (NIV)
The duration of oxygen alone supplementation and any non-invasive ventilation (NIV) during the study are presented by treatment group.
PMA=Post-Menstrual Age PNA=Post-Natal Age
Measured: First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks Post-Menstrual Age (PMA).
Efficacy: Neonates Needing Additional 2 or 3 Doses of Surfactant
A summary of the percentage of neonates requiring at least one additional dose of surfactant, and respective statistical analysis, is presented by treatment group i.e. 2 or 3 doses of surfactant .
Measured: First 72 hours of life.
Efficacy: Neonates Needing Additional Surfactant Doses
A summary of the percentage of neonates requiring at least one additional dose of surfactant, and respective statistical analysis, is presented by treatment group.
Measured: First 72 hours of life.
Efficacy: Preductal Oxygen Saturation/Fraction of Inspired Oxygen (SpO2/FiO2) Ratio
The mean SpO2/FiO2 ratio values at timepoints up to and including 120 hours post-treatment, and respective statistical analyses, are summarized by treatment group.
Measured: Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.
Efficacy: Fraction of Inspired Oxygen (FiO2)
The FiO2 values at timepoints up to and including 120 hours post-treatment and the changes from pre-procedure to each of those timepoints are presented by treatment group.
The fraction of inspired oxygen (FiO2) is the concentration of oxygen in the gas mixture.
Measured: Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.
Efficacy: Preductal Oxygen Saturation (SpO2)
The mean SpO2 values at timepoints up to and including 120 hours post-treatment are summarized by treatment group.
Oxygen saturation (SpO2) is a measurement of how much oxygen the blood is carrying as a percentage of the maximum it could carry.
Measured: Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.
Efficacy: Percentage of Neonates Needing Any Intubation Procedure, Outside the Initial Surfactant Administration Period
The percentage of neonates needing any intubation procedure, outside the initial surfactant administration period (i.e., excluding endotracheal intubation[s] that were required for surfactant administration in the Conventional administration arm), in the first 72 hours of life, in the first 28 days post-natal age (PNA), and within 36 weeks Post-menstrual age (PMA), and respective statistical analyses, are presented.
Measured: First 72 hours of life, up to 28 days post-natal age (PNA), Up to 36 weeks Post-menstrual age (PMA)
Efficacy: Median Duration of Invasive Mechanical Ventilation During the Study
The duration of invasive ventilation (MV) in the first 28 days PNA, and within 36 weeks PMA, are presented by treatment group.
Participants who actually received invasive ventilation are reported in the table below.
Measured: Up to 28 days PNA, Up to 36 weeks PMA
Efficacy: Duration of Invasive Mechanical Ventilation During the Study
The duration of invasive ventilation (MV) in the first 72 hours of life and respective statistical analyses, are presented by treatment group.
Measured: First 72 hours of life
Efficacy: Percentage of Neonates Needing Invasive Mechanical Ventilation (MV) During the Study
The percentage of neonates needing invasive mechanical ventilation (MV) in the first 72 hours of life, in the first 28 days post-natal age (PNA), and within 36 weeks Post-Menstrual Age (PMA), and respective statistical analyses, are presented by treatment group.
Measured: First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks PMA
Efficacy: Blood Gas Analysis Parameters -- pH
The blood gas analysis for blood pH at all timepoints and the changes from pre-procedure to each timepoint are presented.
Results for pH values are based on a scale of 0 to 14. A pH value of 7 is neutral, pH less than 7 is acidic, and pH greater than 7 is basic.
Measured: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Carbon Dioxide (pCO2)
The blood gas analysis partial pressure of carbon dioxide (pCO2) at all timepoints and the changes from pre-procedure to each timepoint are presented.
Measured: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Oxygen (pO2)
The blood gas analysis partial pressure of oxygen (pO2) at all timepoints and the changes from pre-procedure to each timepoint are presented.
Measured: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Analysis Parameter -- Bicarbonate (HCO3^-)
The blood concentration of bicarbonate (HCO3^-) at all timepoints and the changes from pre-procedure to each timepoint are presented.
Measured: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Analysis Parameter -- Base Excess
The blood base excess at all timepoints and the changes from pre-procedure to each timepoint are presented.
Base excess is defined as the amount of acid that must be added to each litre of fully oxygenated blood to return the pH to 7.40 at a temperature of 37°C and a pCO2 of 40 mmHg (5.3 kPa). The value is reported as a concentration in units of milliequivalent per liter (mEq/L), with positive numbers indicating an excess of base and negative a deficit.
Measured: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Analysis Parameter -- Lactate
The blood concentration of lactate at all timepoints and the changes from pre-procedure to each timepoint are presented.
Measured: First 72 hours of life (1h, 6h, 24h, 48h, 72h)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 May 202113 Aug 2022

First posted13 May 2016 (estimated)
Study start18 May 2021
Primary completion13 Aug 2022
Study completion13 Aug 2022

Why it stopped: Sponsor decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory Distress Syndrome (RDS)Studies of the same condition, open and under way.
More trials run by Chiesi Farmaceutici S.p.A.The 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02772081
Sponsor's protocol ID: CCD-050000-01
Acronym: LISPAP
Status last verified: Nov 2023
First submitted: 6 May 2016
Last updated: 7 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
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Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
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REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
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All Respiratory Distress Syndrome (RDS) trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates With Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (Poractant Alfa, CUROSURF®) Administration: A Less Invasive Method (LISA) During Non-invasive Ventilation (NIV) and the Conventional Administration During Brief Invasive Ventilation.
ClinicalTrials.gov ID: NCT02772081
Acronym / sponsor ID: LISPAP / CCD-050000-01
Conditions: Respiratory Distress Syndrome (RDS)
Keywords: Less Invasive Surfactant administration, LISPAP, Neonates, Newborns, Respiratory Distress Syndrome (RDS), CUROSURF®
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 33 participants (actual)
Lead sponsor: Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
Study start: 18 May 2021 (actual)
Primary completion: 13 Aug 2022 (actual)
Study completion: 13 Aug 2022 (actual)
First posted: 13 May 2016 (estimated)
Results: Posted 3 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The Sponsor decided to terminate the study early, due to uncertain sufficient availability of the CHF 6440 catheter.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Curosurf LISA	Experimental	Combination Product: LISA combination product (Curosurf+catheter CHF6440)Single dose of poractant alfa 200 mg/kg via brief insertion of a thin catheter (CHF 6440) into the trachea in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed.
Curosurf Endotracheal Tube	Active comparator	Drug: Curosurf through conventional administration (endotracheal tube)Single dose of poractant alfa 200 mg/kg via the conventional intubation with endotracheal tube in neonates with RDS. A second surfactant dose at 100 mg/kg will be administered with the same technique as the first dosage administration if needed. After the first and second surfactant administration, neonates could receive a third surfactant dose at 100 mg/kg through a standard technique if needed.

Who may qualify

Ages: 30 minutes to 24 hours
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Written informed consent obtained by parents/legal representative (according to local regulation) prior to or after birth
Preterm neonates of either sex aged ≥30 minutes and <24 hours, spontaneously breathing and stabilized on non-invasive ventilation (NIV).
Gestational age of 25+0 weeks up to 28+6 completed weeks, except for the first 15 enrolled neonates in which the gestational age will be restricted to 27+0 weeks up to 28+6 weeks.
Clinical course consistent with RDS.
Fraction of inspired oxygen (FiO2) ≥0.30 to maintain preductal oxygen saturation (SpO2) between 88-95%.

Key exclusion criteria (10 listed)

Need for immediate endotracheal intubation for cardiopulmonary resuscitation or insufficient respiratory drive
Use of nasal high frequency oscillatory ventilation (nHFOV) prior to study entry
Use of surfactant prior to study entry and need for intratracheal administration of any other treatment (e.g. nitric oxide)
Known genetic or chromosomal disorders, major congenital anomalies (congenital heart diseases, myelomeningocele etc)
Mothers with prolonged rupture of the membranes (> 21 days duration)

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
LISA combination product (Curosurf+catheter CHF6440)Curosurf administration through brief insertion of a thin catheter into the trachea	Combination product	Curosurf LISA
Curosurf through conventional administration (endotracheal tube)Curosurf through conventional administration (endotracheal tube), followed by rapid extubation	Drug	Curosurf Endotracheal Tube

Primary outcome

Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment
Time frame: First 72 hours of life.
Extent of exposure to study treatment is summarized by treatment group. Number of participants who received 1, 2, or 3 doses of treatment. All neonates received the first administration of Curosurf® 200 mg/kg. In case of lack of efficacy or clinical deterioration, a second dose of Curosurf® 100 mg/kg was administered using the same technique as the first dose. Neonates could receive a third Curosurf® 100 mg/kg dose if needed, administered using a standard technique. Results are presented as the number of neonates who received 1, 2, or 3 doses of Curosurf®, administered.
Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube
Time frame: At first surfactant administration, up to Day 1.
Number of participants for whom the first attempt failed to insert the catheter/endotracheal tube and the percentage of neonates with first failed attempt, is presented by treatment group.
Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization
Time frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Number of manoeuvres (attempts) discontinued, due to neonate's severe destabilization is presented by treatment group.
Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion
Time frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Number of attempts required to achieve first successful insertion is presented by treatment group.
Safety: Study Treatment Administration: Number of Device Misallocation for LISA Administration Group (Esophageal Insertion)
Time frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Number of device misallocation for LISA administration group (esophageal insertion). Data was not collected from participants in the "Curosurf Endotracheal Tube" -- the control arm of the study, because it is not applicable.
Safety: Study Treatment Administration: Duration of Surfactant Administration
Time frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Duration of surfactant administration is presented by treatment group.
Safety: Study Treatment Administration: Duration of the Whole Procedure
Time frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.
Duration of the whole procedure (starting from the insertion of laryngoscope up to the removal of the catheter/ETT), is presented by treatment group.

16 secondary outcomes

Efficacy: Duration of Oxygen Alone Supplementation and Any Non-Invasive Ventilation (NIV)
Time frame: First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks Post-Menstrual Age (PMA).
Efficacy: Neonates Needing Additional 2 or 3 Doses of Surfactant
Time frame: First 72 hours of life.
Efficacy: Neonates Needing Additional Surfactant Doses
Time frame: First 72 hours of life.
Efficacy: Preductal Oxygen Saturation/Fraction of Inspired Oxygen (SpO2/FiO2) Ratio
Time frame: Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.
Efficacy: Fraction of Inspired Oxygen (FiO2)
Time frame: Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.
Efficacy: Preductal Oxygen Saturation (SpO2)
Time frame: Pre-procedure, at time 0 (T0, end of surfactant instillation) and post treatment after T0 at 5, 15, 30 minutes, at 1, 6, 12, 24, 48, 72, and 120 hours, on Day 28 PNA, 36 weeks PMA.
Efficacy: Percentage of Neonates Needing Any Intubation Procedure, Outside the Initial Surfactant Administration Period
Time frame: First 72 hours of life, up to 28 days post-natal age (PNA), Up to 36 weeks Post-menstrual age (PMA)
Efficacy: Median Duration of Invasive Mechanical Ventilation During the Study
Time frame: Up to 28 days PNA, Up to 36 weeks PMA
Efficacy: Duration of Invasive Mechanical Ventilation During the Study
Time frame: First 72 hours of life
Efficacy: Percentage of Neonates Needing Invasive Mechanical Ventilation (MV) During the Study
Time frame: First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks PMA
Efficacy: Blood Gas Analysis Parameters -- pH
Time frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Carbon Dioxide (pCO2)
Time frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Gas Analysis Parameters -- Partial Pressure of Oxygen (pO2)
Time frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Analysis Parameter -- Bicarbonate (HCO3^-)
Time frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Analysis Parameter -- Base Excess
Time frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)
Efficacy: Blood Analysis Parameter -- Lactate
Time frame: First 72 hours of life (1h, 6h, 24h, 48h, 72h)

Results and safety

Results posted to the registry on 3 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Curosurf LISA	20	18
Curosurf Endotracheal Tube	13	11

Primary outcome: Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment

Time frame: First 72 hours of life.. Count of participants. Unit: Participants

Measure	Curosurf LISA n = 19	Curosurf Endotracheal Tube n = 12
Number of Curosurf® dose, n=1 dose	13	9
Number of Curosurf® doses, n=2 doses	4	2
Number of Curosurf® doses, n=3 doses	2	1

Population analysed: Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Primary outcome: Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube

Time frame: At first surfactant administration, up to Day 1.. Count of participants. Unit: Participants

Measure	Curosurf LISA n = 19	Curosurf Endotracheal Tube n = 12
Value	5	5

Curosurf LISA vs Curosurf Endotracheal Tube: Adjusted difference: -15.4 (95% CI -47.9 to 17.1), p = 0.390, Cochran-Mantel-Haenszel

Population analysed: Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Primary outcome: Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization

Time frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.. Mean (Full Range). Unit: Number of maneuvers (attempts)

Measure	Curosurf LISA n = 19	Curosurf Endotracheal Tube n = 12
First administration	0.1 (0 to 1)	0.0 (0 to 0)
Second administration	0.3 (0 to 1)	0.0 (0 to 0)

Population analysed: Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

Primary outcome: Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion

Time frame: At first surfactant administration, up to Day 1 or at second administration, up to 2 days.. Mean (Full Range). Unit: Number of maneuvers (attempts)

Measure	Curosurf LISA n = 19	Curosurf Endotracheal Tube n = 12
First administration	1.3 (1 to 2)	1.8 (1 to 5)
Second administration	2.0 (1 to 3)	1.0 (1 to 1)

Population analysed: Safety population (SAF): All randomized neonates who received at least one dose of study treatment.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) and serious AEs (SAEs) that started on or after the date of first randomized treatment administration up to the end of the main phase of the study. The main phase of the study included all time points from the pre-randomization period up to and including the follow-up visit at discharge home or 40 weeks PMA, whichever came first.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Curosurf LISA	1 of 19 (5.3%)	19 of 19 (100%)	1 of 19
Curosurf Endotracheal Tube	2 of 12 (16.7%)	12 of 12 (100%)	1 of 12

Limitations and caveats (from the sponsor): The Sponsor issued an early notification of an immediate enrolment hold to participating study sites (01 June 2022) and an official notification (05 July 2022) after identifying uncertain availability of the CHF 6440 catheter. Because the availability of CHF 6440 catheter to all participating study sites could not be assured, the Sponsor decided to terminate the study early.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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.

Rangasamy Ramanathan, M.D. principal investigator

LAC+USC Medical Center & Good Samaritan Hospital

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment (time frame: First 72 hours of life.). The study lists 7 primary outcomes in all. 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 NCT02772081.

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 7 Nov 2023.