Respiratory Distress SyndromeECOSURFNCT04330443
Lung Ultrasound to Guide Surfactant Therapy
A study testing Surfactant therapy in people with Respiratory Distress Syndrome, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
Trial summary
Inclusion criteria are premature newborns under the gestational age (GA) of 32 weeks old with RDS, defined as the need of non invasive mechanical ventilation to keep peripheral oxygen saturation (SpO2) >90% and clinical signs of respiratory distress (polypnea, chest retractions, nasal flutter). Read more about this study
- Who is it for?
- Ages 24 to 32 weeks
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Surfactant therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2019to 10 May 2020
- 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 24 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- premature newborns under the gestational age (GA) of 32 weeks old with respiratory distress syndrome
Who cannot join
- non-acceptance of the informed consent, chromosomal abnormalities, complex congenital malformations, signs of congenital septic shock and mechanical ventilation or endotracheal surfactant prior to the ultrasoundLUS
Trial locations and contacts
1 site in 1 country.
About this study
Inclusion criteria are premature newborns under the gestational age (GA) of 32 weeks old with RDS, defined as the need of non invasive mechanical ventilation to keep peripheral oxygen saturation (SpO2) >90% and clinical signs of respiratory distress (polypnea, chest retractions, nasal flutter).
Exclusion criteria are non-acceptance of the informed consent, chromosomal abnormalities, complex congenital malformations, signs of congenital septic shock and mechanical ventilation or endotracheal surfactant prior to the lung ultrasound.
Read more
The main objective of the study is to determine if a diagnostic of respiratory distress syndrome guided by a lung ultrasound algorithm allow an earlier surfactant therapy (within the first 2 hours of life) comparing to chest X ray Secondary objectives were to assess FiO2 reached before surfactant therapy in patients surfacted according to the lung ultrasound score, the influence of the lung ultrasound algorithm regarding the respiratory evolution, and its differences comparing to the FiO2group. Respiratory evolution was defined as the need of mechanical ventilation, second dose of surfactant, duration of non invasive ventilation, number of days with oxygen requirements, length of stay in the neonatal intensive care unit, evolution to bronchopulmonary dysplasia and their progression to discharge from hospital.
Patients who met the inclusion criteria were randomly assigned to two groups. using the "random" function in MS-Excel XP® program. A total of 6 physicians enrolled participants, all them fully trained for the use of lung ultrasound. The principal investigator assigned participants to interventions, depending on the randomized list.
- Experimental Group 1: The neonatologist-researcher (NR) performed the lung ultrasond at admission during the first hour of life. The neonatologist-assistant (NA) of the baby was not blinded to the result of the lung ultrasound. If the patient had a lung ultrasound score higher than >8 or when FiO2 exceeded 30% patient received surfactant therapy during in the first 72 hours of life . This lung ultrasound threshold is the one with best diagnostic accuracy.
- Control Group 2: The NR performed the at admission/suspicion during the first hour of life. The NA was not blinded to the result of the ultrasound. Patient received surfactant therapy only when FiO2 exceeded 30% during the first 72 hours of life
Read the detailed description
Inclusion criteria are premature newborns under the gestational age (GA) of 32 weeks old with RDS, defined as the need of non invasive mechanical ventilation to keep peripheral oxygen saturation (SpO2) >90% and clinical signs of respiratory distress (polypnea, chest retractions, nasal flutter).
Exclusion criteria are non-acceptance of the informed consent, chromosomal abnormalities, complex congenital malformations, signs of congenital septic shock and mechanical ventilation or endotracheal surfactant prior to the lung ultrasound.
The main objective of the study is to determine if a diagnostic of respiratory distress syndrome guided by a lung ultrasound algorithm allow an earlier surfactant therapy (within the first 2 hours of life) comparing to chest X ray Secondary objectives were to assess FiO2 reached before surfactant therapy in patients surfacted according to the lung ultrasound score, the influence of the lung ultrasound algorithm regarding the respiratory evolution, and its differences comparing to the FiO2group. Respiratory evolution was defined as the need of mechanical ventilation, second dose of surfactant, duration of non invasive ventilation, number of days with oxygen requirements, length of stay in the neonatal intensive care unit, evolution to bronchopulmonary dysplasia and their progression to discharge from hospital.
Patients who met the inclusion criteria were randomly assigned to two groups. using the "random" function in MS-Excel XP® program. A total of 6 physicians enrolled participants, all them fully trained for the use of lung ultrasound. The principal investigator assigned participants to interventions, depending on the randomized list.
- Experimental Group 1: The neonatologist-researcher (NR) performed the lung ultrasond at admission during the first hour of life. The neonatologist-assistant (NA) of the baby was not blinded to the result of the lung ultrasound. If the patient had a lung ultrasound score higher than >8 or when FiO2 exceeded 30% patient received surfactant therapy during in the first 72 hours of life . This lung ultrasound threshold is the one with best diagnostic accuracy.
- Control Group 2: The NR performed the at admission/suspicion during the first hour of life. The NA was not blinded to the result of the ultrasound. Patient received surfactant therapy only when FiO2 exceeded 30% during the first 72 hours of life
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Surfactant therapy
- 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.
Surfactant therapyProcedure or surgery
To study if lung ultrasound allows an earlier surfactant therapy (within the first 2 hours of life) compare to FiO2 and Chest X Ray
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | Experimental | The neonatologist-researcher (NR) performed the lung ultrasound at admission during the first hour of life. The neonatologist-assistant (NA) of the baby was not blinded to the result of the lung ultrasound. If the patient had a lung ultrasound score higher than >8 or when FiO2 exceeded 30% patient received surfactant therapy during in the first 72 hours of life Receives: Procedure: Surfactant therapy |
| Chest X Ray | No intervention | The NR performed the LUS at admission/suspicion during the first hour of life. The NA was not blinded to the result of the LUS. Patient received surfactant therapy only when FiO2 exceeded 30% during the first 72 hours of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precocious surfactant administration
Number of patients which receive surfactant therapy during the first 2 hours of life
Measured: 2 monthts
Secondary outcomes (1)
assess FiO2 reached before surfactant therapy in patients surfacted according to the LUS score
assess FiO2 reached before surfactant therapy in patients surfacted according to the LUS score
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start1 Mar 2019
- Primary completion1 May 2020
- Study completion10 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330443
- Sponsor's protocol ID
- 136/2019
- Acronym
- ECOSURF
- Status last verified
- May 2020
- First submitted
- 20 Mar 2020
- Last updated
- 15 May 2020
- 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 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Ultrasound to Guide Surfactant Therapy
- ClinicalTrials.gov ID
- NCT04330443
- Acronym / sponsor ID
- ECOSURF / 136/2019
- Conditions
- Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 10 May 2020 (actual)
- First posted
- 1 Apr 2020 (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.
Inclusion criteria are premature newborns under the gestational age (GA) of 32 weeks old with RDS, defined as the need of non invasive mechanical ventilation to keep peripheral oxygen saturation (SpO2) >90% and clinical signs of respiratory distress (polypnea, chest retractions, nasal flutter).
Exclusion criteria are non-acceptance of the informed consent, chromosomal abnormalities, complex congenital malformations, signs of congenital septic shock and mechanical ventilation or endotracheal surfactant prior to the lung ultrasound.
The main objective of the study is to determine if a diagnostic of respiratory distress syndrome guided by a lung ultrasound algorithm allow an earlier surfactant therapy (within the first 2 hours of life) comparing to chest X ray Secondary objectives were to assess FiO2 reached before surfactant therapy in patients surfacted according to the lung ultrasound score, the influence of the lung ultrasound algorithm regarding the respiratory evolution, and its differences comparing to the FiO2group. Respiratory evolution was defined as the need of mechanical ventilation, second dose of surfactant, duration of non invasive ventilation, number of days with oxygen requirements, length of stay in the neonatal intensive care unit, evolution to bronchopulmonary dysplasia and their progression to discharge from hospital.
Patients who met the inclusion criteria were randomly assigned to two groups. using the "random" function in MS-Excel XP® program. A total of 6 physicians enrolled participants, all them fully trained for the use of lung ultrasound. The principal investigator assigned participants to interventions, depending on the randomized list.
- Experimental Group 1: The neonatologist-researcher (NR) performed the lung ultrasond at admission during the first hour of life. The neonatologist-assistant (NA) of the baby was not blinded to the result of the lung ultrasound. If the patient had a lung ultrasound score higher than >8 or when FiO2 exceeded 30% patient received surfactant therapy during in the first 72 hours of life . This lung ultrasound threshold is the one with best diagnostic accuracy.
- Control Group 2: The NR performed the at admission/suspicion during the first hour of life. The NA was not blinded to the result of the ultrasound. Patient received surfactant therapy only when FiO2 exceeded 30% during the first 72 hours of life
Detailed description
Inclusion criteria are premature newborns under the gestational age (GA) of 32 weeks old with RDS, defined as the need of non invasive mechanical ventilation to keep peripheral oxygen saturation (SpO2) >90% and clinical signs of respiratory distress (polypnea, chest retractions, nasal flutter).
Exclusion criteria are non-acceptance of the informed consent, chromosomal abnormalities, complex congenital malformations, signs of congenital septic shock and mechanical ventilation or endotracheal surfactant prior to the lung ultrasound.
The main objective of the study is to determine if a diagnostic of respiratory distress syndrome guided by a lung ultrasound algorithm allow an earlier surfactant therapy (within the first 2 hours of life) comparing to chest X ray Secondary objectives were to assess FiO2 reached before surfactant therapy in patients surfacted according to the lung ultrasound score, the influence of the lung ultrasound algorithm regarding the respiratory evolution, and its differences comparing to the FiO2group. Respiratory evolution was defined as the need of mechanical ventilation, second dose of surfactant, duration of non invasive ventilation, number of days with oxygen requirements, length of stay in the neonatal intensive care unit, evolution to bronchopulmonary dysplasia and their progression to discharge from hospital.
Patients who met the inclusion criteria were randomly assigned to two groups. using the "random" function in MS-Excel XP® program. A total of 6 physicians enrolled participants, all them fully trained for the use of lung ultrasound. The principal investigator assigned participants to interventions, depending on the randomized list.
- Experimental Group 1: The neonatologist-researcher (NR) performed the lung ultrasond at admission during the first hour of life. The neonatologist-assistant (NA) of the baby was not blinded to the result of the lung ultrasound. If the patient had a lung ultrasound score higher than >8 or when FiO2 exceeded 30% patient received surfactant therapy during in the first 72 hours of life . This lung ultrasound threshold is the one with best diagnostic accuracy.
- Control Group 2: The NR performed the at admission/suspicion during the first hour of life. The NA was not blinded to the result of the ultrasound. Patient received surfactant therapy only when FiO2 exceeded 30% during the first 72 hours of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Experimental | Procedure: Surfactant therapyThe neonatologist-researcher (NR) performed the lung ultrasound at admission during the first hour of life. The neonatologist-assistant (NA) of the baby was not blinded to the result of the lung ultrasound. If the patient had a lung ultrasound score higher than >8 or when FiO2 exceeded 30% patient received surfactant therapy during in the first 72 hours of life |
| Chest X Ray | No intervention | –The NR performed the LUS at admission/suspicion during the first hour of life. The NA was not blinded to the result of the LUS. Patient received surfactant therapy only when FiO2 exceeded 30% during the first 72 hours of life |
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- premature newborns under the gestational age (GA) of 32 weeks old with respiratory distress syndrome
Key exclusion criteria (1 listed)
- non-acceptance of the informed consent, chromosomal abnormalities, complex congenital malformations, signs of congenital septic shock and mechanical ventilation or endotracheal surfactant prior to the ultrasoundLUS
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 |
|---|---|---|
| Surfactant therapyTo study if lung ultrasound allows an earlier surfactant therapy (within the first 2 hours of life) compare to FiO2 and Chest X Ray | Procedure or surgery | Ultrasound group |
Primary outcome
Precocious surfactant administration
Time frame: 2 monthts
Number of patients which receive surfactant therapy during the first 2 hours of life
1 secondary outcome
assess FiO2 reached before surfactant therapy in patients surfacted according to the LUS score
Time frame: 2 months
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 15 May 2020.
- 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 Surfactant therapy in people with Respiratory Distress Syndrome, run by Institut Investigacio Sanitaria Pere Virgili at 1 site in Spain.
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 1 inclusion and 1 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 15 May 2020. 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 Spain. 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?
Precocious surfactant administration (time frame: 2 monthts). 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 15 May 2020.