Respiratory Distress Syndrome, NewbornPhase 4NCT01173237
Efficacy Evaluation of Surfactant Administration Via Laryngeal Mask Airway
A Phase 4 study testing Use tracheal intubation for surfactant therapy and Use of Proseal laryngeal mask airway for surfactant therapy in people with Respiratory Distress Syndrome, Newborn, run by Federal University of Minas Gerais at 2 sites in Brazil.
Trial summary
With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. Read more about this study
- Who is it for?
- Ages 30 minutes to 8 hours
- Conditions the study is for
- Respiratory Distress Syndrome, Newborn
- What is being tested?
- Use tracheal intubation for surfactant therapy and Use of Proseal laryngeal mask airway for surfactant therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- Jul 2011to Jul 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 30 minutes to 8 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birthweight more than 1000 grams
- Gestational age more than 28 weeks and less than 35 weeks
- Chronologic age less than 8 hours
- Diagnosis of RDS by clinical and radiographic criteria
- Treated with nasal continuous positive airway pressure and supplemental oxygen more than 30%
- Parental consent
Who cannot join
- Birthweight less than 1000 grams
- Gestational age more than 28 weeks and less than 35 weeks
- Chronologic age more than 8 hours
- Maternal fever or premature rupture of fetal membranes less than 18 hours
- Diagnosis other than respiratory distress syndrome
- Babies who require or have already had endotracheal intubation
Show all 9Show fewer
- Analgesia and or sedation during the first six hours of life
- Apgar 5 minute score less than three
- Babies with congenital anomalies or signs of acute circulatory failure
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Maternidade Odete Valadares
Belo Horizonte, Minas Gerais, 30110-072
Rosilu F Barbosa, MD, MSc, 00 55 31 88144163, rosilu@gmail.com
Yerkes P Silva, MD, MSc, PhD
Hospital Dia e Maternidade Unimed-BH
Belo Horizonte, Minas Gerais, 30431-253
Rosilu F Barbosa, MD, MSc, 00 55 31 88144163, rosilu@gmail.com
Yerkes P Silva, MD. MSc, PhD
About this study
Official title: Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial
With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. Preterm newborn babies until eight hours of life, with respiratory distress syndrome, will be randomized to standard delivery of surfactant via endotracheal tube airway inserted after premedication for pain with midazolam and remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent is to is to compare efficacy and safety of surfactant administration via two different airways and ventilatory approaches.
- Conditions
- Respiratory Distress Syndrome, Newborn
- Being tested
- Use tracheal intubation for surfactant therapy, Use of Proseal laryngeal mask airway for surfactant therapy
- Keywords
- tracheal intubation, proseal laryngeal mask airway, neonate, surfactant, respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use tracheal intubation for surfactant therapyProcedure or surgery
Also called Endotracheal tube
Surfactant endotracheal administration after tracheal intubation
Use of Proseal laryngeal mask airway for surfactant therapyProcedure or surgery
Also called Laryngeal mask airway
Surfactant use by proseal laryngeal mask airway
| Study group | Role | What they receive |
|---|---|---|
| Tracheal intubation | Active comparator | Endotracheal tube is a airway device used for ventilation or surfactant administration, in preterm babies with SDR surfactant deficiency. Receives: Procedure: Use tracheal intubation for surfactant therapy |
| Proseal laryngeal mask airway | Experimental | Laryngeal mask airway is a airway device used for ventilation with self-inflating bag or flow-inflating bag. In this study it will be used for surfactant administration, in preterm babies with SDR surfactant deficiency. Receives: Procedure: Use of Proseal laryngeal mask airway for surfactant therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fraction of inspired oxygen
Measured: three hours
Secondary outcomes (3)
Hormonal evaluation of pain
Measured: three hours
Proseal laryngeal mask surfactant treatment failure
Measured: Six hours
Rate of respiratory distress syndrome complications
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startJul 2011
- Primary completionMar 2012 (estimated)
- Study completionJul 2013 (estimated)
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Investigators
- Yerkes P Silva, PhD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173237
- Sponsor's protocol ID
- CAAE 00160287000-10
- Status last verified
- Jul 2010
- First submitted
- 26 Jul 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of Surfactant Administration for Respiratory Distress Syndrome Treatment Via Laryngeal Mask Airway. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01173237
- Acronym / sponsor ID
- CAAE 00160287000-10
- Conditions
- Respiratory Distress Syndrome, Newborn
- Keywords
- tracheal intubation, proseal laryngeal mask airway, neonate, surfactant, respiratory distress syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 2 Aug 2010 (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.
With the development of the Intubation Surfactant Extubation technic, in which surfactant is administered during a brief intubation followed by immediate extubation, surfactant therapy can be given during nasal continuous positive airway pressure treatment further reducing need for mechanical ventilation. Preterm newborn babies until eight hours of life, with respiratory distress syndrome, will be randomized to standard delivery of surfactant via endotracheal tube airway inserted after premedication for pain with midazolam and remifentanil or to surfactant delivery via Proseal laryngeal mask airway size 1. The intent is to is to compare efficacy and safety of surfactant administration via two different airways and ventilatory approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tracheal intubation | Active comparator | Procedure: Use tracheal intubation for surfactant therapyEndotracheal tube is a airway device used for ventilation or surfactant administration, in preterm babies with SDR surfactant deficiency. |
| Proseal laryngeal mask airway | Experimental | Procedure: Use of Proseal laryngeal mask airway for surfactant therapyLaryngeal mask airway is a airway device used for ventilation with self-inflating bag or flow-inflating bag. In this study it will be used for surfactant administration, in preterm babies with SDR surfactant deficiency. |
Who may qualify
- Ages
- 30 minutes to 8 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birthweight more than 1000 grams
- Gestational age more than 28 weeks and less than 35 weeks
- Chronologic age less than 8 hours
- Diagnosis of RDS by clinical and radiographic criteria
- Treated with nasal continuous positive airway pressure and supplemental oxygen more than 30%
Key exclusion criteria (9 listed)
- Birthweight less than 1000 grams
- Gestational age more than 28 weeks and less than 35 weeks
- Chronologic age more than 8 hours
- Maternal fever or premature rupture of fetal membranes less than 18 hours
- Diagnosis other than respiratory distress syndrome
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 |
|---|---|---|
| Use tracheal intubation for surfactant therapyAlso: Endotracheal tubeSurfactant endotracheal administration after tracheal intubation | Procedure or surgery | Tracheal intubation |
| Use of Proseal laryngeal mask airway for surfactant therapyAlso: Laryngeal mask airwaySurfactant use by proseal laryngeal mask airway | Procedure or surgery | Proseal laryngeal mask airway |
Primary outcome
Fraction of inspired oxygen
Time frame: three hours
3 secondary outcomes
Hormonal evaluation of pain
Time frame: three hours
Proseal laryngeal mask surfactant treatment failure
Time frame: Six hours
Rate of respiratory distress syndrome complications
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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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.
Yerkes P Silva, PhD principal investigator
Federal University of Minas Gerais
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Use tracheal intubation for surfactant therapy and Use of Proseal laryngeal mask airway for surfactant therapy in people with Respiratory Distress Syndrome, Newborn, run by Federal University of Minas Gerais at 2 sites in Brazil.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rosilu F Barbosa, MD, MSc (00 55 31 88144163, rosilu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fraction of inspired oxygen (time frame: three hours). 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 28 Jun 2011.