Respiratory Distress Syndrome, NewbornPhase 4NCT01941524
Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
A Phase 4 study testing Poractant alfa instillation and Beractant instillation in people with Respiratory Distress Syndrome, Newborn and Respiratory Failure, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations. Read more about this study
- Who is it for?
- Ages 15 minutes to 2 days
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn, Respiratory Failure
- What is being tested?
- Poractant alfa instillation and Beractant instillation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePoland
- Study dates
- 3 Mar 2013to 20 Jun 2015
- 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 15 minutes to 2 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 26-30 gestational age
- surfactant instillation
Who cannot join
- congenital heart disease
- congenital central nervous disorder
- congenital genetic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Cerebral Tissue Oxygenation and the Bioelectrical Brain Activity of Preterm Newborns During Administration of Two Different Surfactant
The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations.
Read the detailed description
Patients randomized to one of the treatment groups: 1) SRT with porcine preparation - poractant alfa; 2) SRT with bovine preparation - beractant. Continuous monitoring and simultaneous recordeding of 1) saturation (SpO2) and heart rate (HR) measured with pulse oximetry, cerebral tissue oxygenation measured with near-infrared spectroscopy, amplitude-integrated electroencephalography.
- Being tested
- Poractant alfa instillation, Beractant instillation
- Keywords
- Brain oxygenation, NIRS, aEEG, surfactant
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poractant alfa instillationDrug
aEEG and NIRS monitoring during poractant alfa instilation
Beractant instillationDrug
aEEG and NRs monitoring during beractant instillation
| Study group | Role | What they receive |
|---|---|---|
| Poractant goup | Active comparator | Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation. Receives: Drug: Poractant alfa instillation |
| Beractant group | Active comparator | Newborns who will be monitored by aEEG and NIRS during beractant instillation Receives: Drug: Beractant instillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral oxygenation
Cerebral tissue oxygenation measured with near-infrared spectroscopy
Measured: 4 hours after surfactant instillation
Brain bioelectrical activity
Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG)
Measured: 4 hours after surfactant instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study start3 Mar 2013
- Primary completion20 Jun 2015
- Study completion20 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, NewbornStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Szczapa, Poznan University of Medical Sciences
- Investigators
- Tomasz Szczapa, M.D., Study director, Poznan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941524
- Sponsor's protocol ID
- 502-14-02215338-09873
- Status last verified
- Mar 2020
- First submitted
- 19 Jun 2013
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Cerebral Tissue Oxygenation and the Bioelectrical Brain Activity of Preterm Newborns During Administration of Two Different Surfactant
- ClinicalTrials.gov ID
- NCT01941524
- Acronym / sponsor ID
- 502-14-02215338-09873
- Keywords
- Brain oxygenation, NIRS, aEEG, surfactant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 3 Mar 2013
- Primary completion
- 20 Jun 2015 (actual)
- Study completion
- 20 Jun 2015 (actual)
- First posted
- 13 Sep 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.
The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations.
Detailed description
Patients randomized to one of the treatment groups: 1) SRT with porcine preparation - poractant alfa; 2) SRT with bovine preparation - beractant. Continuous monitoring and simultaneous recordeding of 1) saturation (SpO2) and heart rate (HR) measured with pulse oximetry, cerebral tissue oxygenation measured with near-infrared spectroscopy, amplitude-integrated electroencephalography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poractant goup | Active comparator | Drug: Poractant alfa instillationNewborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation. |
| Beractant group | Active comparator | Drug: Beractant instillationNewborns who will be monitored by aEEG and NIRS during beractant instillation |
Who may qualify
- Ages
- 15 minutes to 2 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 26-30 gestational age
- surfactant instillation
Key exclusion criteria (3 listed)
- congenital heart disease
- congenital central nervous disorder
- congenital genetic disorders
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 |
|---|---|---|
| Poractant alfa instillationaEEG and NIRS monitoring during poractant alfa instilation | Drug | Poractant goup |
| Beractant instillationaEEG and NRs monitoring during beractant instillation | Drug | Beractant group |
Primary outcome
Cerebral oxygenation
Time frame: 4 hours after surfactant instillation
Cerebral tissue oxygenation measured with near-infrared spectroscopy
Brain bioelectrical activity
Time frame: 4 hours after surfactant instillation
Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG)
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 5 Mar 2020.
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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.
Tomasz Szczapa, M.D. study director
Poznan University of Medical Sciences
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 Poractant alfa instillation and Beractant instillation in people with Respiratory Distress Syndrome, Newborn and Respiratory Failure, run by Poznan University of Medical Sciences at 1 site in Poland.
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 5 Mar 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 Poland. 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?
Cerebral oxygenation (time frame: 4 hours after surfactant instillation). 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 5 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.