Trial · NCT02772081
A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
NCT02772081, Phase 3, Terminated, Chiesi Farmaceutici S.p.A.; results first posted 2023-11-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration. Trials, record NCT02772081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02772081
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Preterm Neonates With Respiratory Distress Syndrome (RDS) Comparing CUROSURF® Administration Through Less Invasive Surfactant Administration (LISA) and Conventional Administration
- NCT number
- NCT02772081
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Conditions
- Respiratory Distress Syndrome (RDS)
- Interventions
- LISA combination product (Curosurf+catheter CHF6440), Curosurf through conventional administration (endotracheal tube)
- First posted
- 2016-05-13
- Last updated
- 2023-11-07
- Results first posted
- 2023-11-03
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment | 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. |
| Primary | Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube | 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. |
| Primary | Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization | 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. |
| Primary | Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion | 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. |
| Primary | Safety: Study Treatment Administration: Number of Device Misallocation for LISA Administration Group (Esophageal Insertion) | 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. |
| Primary | Safety: Study Treatment Administration: Duration of Surfactant Administration | 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. |
| Primary | Safety: Study Treatment Administration: Duration of the Whole Procedure | 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. |
| Secondary | Efficacy: Duration of Oxygen Alone Supplementation and Any Non-Invasive Ventilation (NIV) | First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks Post-Menstrual Age (PMA). | 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 |
| Secondary | Efficacy: Neonates Needing Additional 2 or 3 Doses of Surfactant | First 72 hours of life. | 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 . |
| Secondary | Efficacy: Neonates Needing Additional Surfactant Doses | First 72 hours of life. | A summary of the percentage of neonates requiring at least one additional dose of surfactant, and respective statistical analysis, is presented by treatment group. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment | First 72 hours of life. | Safety population (SAF): All randomized neonates who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube | At first surfactant administration, up to Day 1. | Safety population (SAF): All randomized neonates who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Safety population (SAF): All randomized neonates who received at least one dose of study treatment. | Number of maneuvers (attempts) | MEAN |
| PRIMARY | Safety: Study Treatment Administration: Number of Attempts to First Successful Insertion | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Safety population (SAF): All randomized neonates who received at least one dose of study treatment. | Number of maneuvers (attempts) | MEAN |
| PRIMARY | Safety: Study Treatment Administration: Number of Device Misallocation for LISA Administration Group (Esophageal Insertion) | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Safety population (SAF): All randomized neonates who received at least one dose of study treatment. | Number of maneuvers (attempts) | MEAN |
| PRIMARY | Safety: Study Treatment Administration: Duration of Surfactant Administration | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Safety population (SAF): All randomized neonates who received at least one dose of study treatment. | minutes | MEAN |
| PRIMARY | Safety: Study Treatment Administration: Duration of the Whole Procedure | At first surfactant administration, up to Day 1 or at second administration, up to 2 days. | Safety population (SAF): All randomized neonates who received at least one dose of study treatment. | minutes | MEAN |
| SECONDARY | Efficacy: Duration of Oxygen Alone Supplementation and Any Non-Invasive Ventilation (NIV) | First 72 hours of life, Up to 28 days Post-Natal Age (PNA), Up to 36 weeks Post-Menstrual Age (PMA). | Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment. | days | MEAN |
| SECONDARY | Efficacy: Neonates Needing Additional 2 or 3 Doses of Surfactant | First 72 hours of life. | Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Efficacy: Neonates Needing Additional Surfactant Doses | First 72 hours of life. | Intention-to-treat population (ITT): All randomized neonates who received at least one dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group210
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment | Curosurf LISA | Number of Curosurf® dose, n=1 dose | 13 | Participants | |
| Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment | Curosurf Endotracheal Tube | Number of Curosurf® dose, n=1 dose | 9 | Participants | |
| Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment | Curosurf LISA | Number of Curosurf® doses, n=2 doses | 4 | Participants | |
| Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment | Curosurf Endotracheal Tube | Number of Curosurf® doses, n=2 doses | 2 | Participants | |
| Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment | Curosurf LISA | Number of Curosurf® doses, n=3 doses | 2 | Participants | |
| Safety: Study Treatment Administration: Number of Participants Who Received 1, 2, or 3 Doses of Treatment | Curosurf Endotracheal Tube | Number of Curosurf® doses, n=3 doses | 1 | Participants | |
| Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube | Curosurf LISA | 5 | Participants | ||
| Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube | Curosurf Endotracheal Tube | 5 | Participants | ||
| Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization | Curosurf LISA | First administration | 0.1 | Full Range 0 to 1 | Number of maneuvers (attempts) |
| Safety: Study Treatment Administration: Number of Maneuvers Discontinued Due to Neonate's Severe Destabilization | Curosurf Endotracheal Tube | First administration | 0.0 | Full Range 0 to 0 | Number of maneuvers (attempts) |
1 to 10 of 210Source ClinicalTrials.gov
See all 210 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Curosurf LISA | 20 | |
| Overall Study | STARTED | Curosurf Endotracheal Tube | 13 | |
| Overall Study | COMPLETED | Curosurf LISA | 18 | |
| Overall Study | COMPLETED | Curosurf Endotracheal Tube | 11 | |
| Overall Study | NOT COMPLETED | Curosurf LISA | 2 | |
| Overall Study | NOT COMPLETED | Curosurf Endotracheal Tube | 2 |
Source ClinicalTrials.gov
Adverse events140
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia neonatal | Blood and lymphatic system disorders | Curosurf LISA | 10 | 19 | 10 |
| other | Anaemia neonatal | Blood and lymphatic system disorders | Curosurf Endotracheal Tube | 4 | 12 | 4 |
| other | Thrombocytopenia neonatal | Blood and lymphatic system disorders | Curosurf LISA | 2 | 19 | 2 |
| other | Thrombocytopenia neonatal | Blood and lymphatic system disorders | Curosurf Endotracheal Tube | 1 | 12 | 1 |
| other | Bradycardia neonatal | Cardiac disorders | Curosurf LISA | 7 | 19 | 8 |
| other | Bradycardia neonatal | Cardiac disorders | Curosurf Endotracheal Tube | 1 | 12 | 1 |
| other | Neonatal tachycardia | Cardiac disorders | Curosurf LISA | 2 | 19 | 2 |
| other | Neonatal tachycardia | Cardiac disorders | Curosurf Endotracheal Tube | 2 | 12 | 2 |
| other | Supraventricular extrasystoles | Cardiac disorders | Curosurf LISA | 1 | 19 | 1 |
| other | Supraventricular extrasystoles | Cardiac disorders | Curosurf Endotracheal Tube | 0 | 12 | 0 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Curosurf LISA | 1 | 19 |
| Total, all-cause mortality | Curosurf Endotracheal Tube | 1 | 12 |
| Total, other adverse events | Curosurf LISA | 19 | 19 |
| Total, other adverse events | Curosurf Endotracheal Tube | 12 | 12 |
| Total, serious adverse events | Curosurf LISA | 1 | 19 |
| Total, serious adverse events | Curosurf Endotracheal Tube | 2 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Curosurf LISA vs Curosurf Endotracheal Tube: Efficacy: Neonates Needing Additional Surfactant Doses | Trial comparisons |
| Curosurf LISA vs Curosurf Endotracheal Tube: deaths from any cause | Trial comparisons |
| Curosurf LISA vs Curosurf Endotracheal Tube: Safety: Study Treatment Administration: Number of Participants for Whom the First Attempt Failed to Insert the Catheter/Endotracheal Tube | Trial comparisons |
| Curosurf LISA vs Curosurf Endotracheal Tube: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02772081
GET https://conductscience.org/api/trials/v1/NCT02772081/registered?page=2