Respiratory Distress SyndromePhase 4NCT01923844
Effects of Bolus Surfactant Therapy on Peripheral Perfusion Index and Tissue Carbon Monoxide
A Phase 4 study testing exogenous surfactant in people with Respiratory Distress Syndrome, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- exogenous surfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2012to Apr 2013
- Phase
- Phase 4
- 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 Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 26 and 36 weeks
- intubated for respiratory distress syndrome
Who cannot join
- cardiac defects,
- hemodynamically significant patent ductusarteriosus,
- congenital pneumonia,
- early sepsis
- unstable infants in need of inotropic support.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Children's Hospital Neonatal Intesive Care Unit
Izmir, İzmir, 35100
About this study
Official title: Effects of Bolus Surfactant Therapy on Serial Peripheral Perfusion Index and Tissue Carbon Monoxide Measurements in Preterm Infants With Severe Respiratory Distress Syndrome
Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.
Read the detailed description
Preterm infants with severe Respiratory Distress Syndrome (study group) were compared to preterm infants without Respiratory Distress Syndrome(control group). Infants in the study group were randomized to receive either poractantalfa or beractant.
Perfusion index (PI) and transcutaneous CO (TCO) values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- exogenous surfactant
- Keywords
- Newborn, perfusion index, pulsatility index, respiratory distress syndrome, surfactant, transcutaneous carbon monoxide
- 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.
exogenous surfactantDrug
Also called poractantalf, beractant
Preparations of poractantalfa (Curosurf, 200 mg/kg) (n = 15) or beractant (Survanta, 100 mg/kg) (n = 15) were administered in a consecutive randomized manner within the first 6 h of life. During the procedure, the tube was disconnected from the ventilator. The patient's head was held in a neutral position and surfactant preparations were given in two bolus fractions. Manual ventilation was given for 2 min after each dose. After the second dose, the endotracheal tube was reconnected and the physician (D.T.) observed the infant for 30-60 s until the oxygen saturation reached > 90% on pulse oximetry. Thereafter, the peak inspiratory pressure of the 6 ventilator was reduced by 1-2 mmH2O.
| Study group | Role | What they receive |
|---|---|---|
| poractantalfa | Experimental | preterm infants who received poractantalfa for respiratory distress syndrome Receives: Drug: exogenous surfactant |
| beractant | Experimental | preterm infants who received beractant for respiratory distress syndrome Receives: Drug: exogenous surfactant |
| Control | No intervention | Preterm infants without respiratory distress syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in perfusion index (PI)at 6 hours
PI values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
Measured: before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life
Change from baseline in transcutaneous carbon monoxide (TCO)at 6 hours
TCO values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
Measured: before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startMar 2012
- Primary completionApr 2013
- Study completionApr 2013
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.
- More trials run by Ege UniversityThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Yalaz, Ege University
- Investigators
- Mehmet Yalaz, M.D., Principal investigator, Ege University Faculty of Medicine, Department of Pediatrics, Division of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923844
- Sponsor's protocol ID
- surf_pi_co_1
- Status last verified
- Aug 2013
- First submitted
- 13 Aug 2013
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bolus Surfactant Therapy on Serial Peripheral Perfusion Index and Tissue Carbon Monoxide Measurements in Preterm Infants With Severe Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01923844
- Acronym / sponsor ID
- surf_pi_co_1
- Conditions
- Respiratory Distress Syndrome
- Keywords
- Newborn, perfusion index, pulsatility index, respiratory distress syndrome, surfactant, transcutaneous carbon monoxide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Aug 2013 (estimated)
- 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.
Exogenous bolus surfactant administration may affect hemodynamic parameters and peripheral perfusion. Surfactant therapy is commonly used for respiratory distress syndrome in premature infants, which is also associated with inflammation. There are different types and doses of surfactant preparations available. With the help of new generation monitors, changes in peripheral perfusion and transcutaneous CO, a marker of inflammation, may be demonstrated.
Detailed description
Preterm infants with severe Respiratory Distress Syndrome (study group) were compared to preterm infants without Respiratory Distress Syndrome(control group). Infants in the study group were randomized to receive either poractantalfa or beractant.
Perfusion index (PI) and transcutaneous CO (TCO) values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| poractantalfa | Experimental | Drug: exogenous surfactantpreterm infants who received poractantalfa for respiratory distress syndrome |
| beractant | Experimental | Drug: exogenous surfactantpreterm infants who received beractant for respiratory distress syndrome |
| Control | No intervention | –Preterm infants without respiratory distress syndrome |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age between 26 and 36 weeks
- intubated for respiratory distress syndrome
Key exclusion criteria (5 listed)
- cardiac defects,
- hemodynamically significant patent ductusarteriosus,
- congenital pneumonia,
- early sepsis
- unstable infants in need of inotropic support.
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 |
|---|---|---|
| exogenous surfactantAlso: poractantalf, beractantPreparations of poractantalfa (Curosurf, 200 mg/kg) (n = 15) or beractant (Survanta, 100 mg/kg) (n = 15) were administered in a consecutive randomized manner within the first 6 h of life. During the procedure, the tube was disconnected from the ventilator. The patient's head was held in a neutral position and surfactant preparations were given in two bolus fractions. Manual ventilation was given for 2 min after each dose. After the second dose, the endotracheal tube was reconnected and the physician (D.T.) observed the infant for 30-60 s until the oxygen saturation reached > 90% on pulse oximetry. Thereafter, the peak inspiratory pressure of the 6 ventilator was reduced by 1-2 mmH2O. | Drug | beractant, poractantalfa |
Primary outcome
Change from baseline in perfusion index (PI)at 6 hours
Time frame: before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life
PI values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
Change from baseline in transcutaneous carbon monoxide (TCO)at 6 hours
Time frame: before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life
TCO values were measured before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life.
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 16 Aug 2013.
Related trials for Respiratory Distress Syndrome
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Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
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REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
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RecruitingObservational study
Effect of Transpulmonary MP on Prognosis of Patients With Severe ARDS Treated With VV-ECMO
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
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.
Mehmet Yalaz, M.D. principal investigator
Ege University Faculty of Medicine, Department of Pediatrics, Division of Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing exogenous surfactant in people with Respiratory Distress Syndrome, run by Ege University at 1 site in Turkey (Türkiye).
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 5 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 16 Aug 2013. 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 Turkey (Türkiye). 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in perfusion index (PI)at 6 hours (time frame: before (Tp) and 0 (T0), 5 (T5), 30 (T30), 60 (T60), 360 (T360) minutes after surfactant administration in the first six hours of life). The study lists 2 primary outcomes in all. 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 16 Aug 2013.