Respiratory Distress SyndromePhase 4NCT00391105
Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome
A Phase 4 study testing Remifentanil in people with Respiratory Distress Syndrome, run by Federal University of Minas Gerais.
Trial summary
In this randomised controlled study we intended to compared intubation conditions and the continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated premature neonates (28-34wk) regarding the time to be awake and, the time until extubation after interruption of the opioid administration. Read more about this study
- Who is it for?
- Ages 60 minutes to 28 days
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Remifentanil
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2004to Nov 2005
- 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 60 minutes to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 28 and 34 wk
- Clinical and radiological features compatible with respiratory distress syndrome that required an elective tracheal intubation and surfactant therapy.
Who cannot join
- The presence of major congenital malformations
- Birth weigh less than 1000g
- Previous or concurrent use of opioid for any reason (cesarean section with general anaesthesia)
- Hemodynamic instability before the indication of tracheal intubation
- Refuse of the parents to enroll the neonate in the study protocol
About this study
Official title: Comparative Study of the Use of Remifentanil Versus Morphine for Sedation and Analgesia of Premature Neonates During Mechanical Ventilation in the Treatment of Respiratory Distress Syndrome (RDS)
In this randomised controlled study we intended to compared intubation conditions and the continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated premature neonates (28-34wk) regarding the time to be awake and, the time until extubation after interruption of the opioid administration.
Read the detailed description
Intubation and mechanical ventilation are majors component of intensive care for premature neonates with respiratory distress syndrome (RDS) and is associated with physiologic, biochemical, and clinical responses indicating pain and stress in prematures. Although morphine is one of the most used drugs for premedication and for sedation and analgesia during mechanical ventilation in the treatment of RDS its pharmacological profile precludes several limitations mostly due to its much delayed onset of action what makes the drug not suitable as premedication and due to its prolonged duration of action mainly in prematures. Unlike morphine, remifentanil has an unique pharmacokinetic properties with a rapid onset of action and, a fast decrease in plasma concentration after interruption of administration due to a context-sensitive half-time of 3.2 minutes. So, it could be the ideal opioid for neonates who are especially sensitive to respiratory depression by opioids
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Remifentanil
- Keywords
- intubation, Sedation, Analgesia, preterm neonate, remifentanil, morphine, respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubation conditions using a four point scale
Decrease in time after interruption of sedation until the neonate be awake.
Decrease in time after interruption of sedation until the neonate be extubated.
Secondary outcomes (2)
Pain and stress before and after intubation (NIPS and Comfort scores).
Pain and stress during continuous infusion of remifentanil versus morphine during mechanical ventilation for the treatment of respiratory distress syndrome (NIPS and Comfort scores).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2006 (estimated)
- Study startApr 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Investigators
- Yerkes P Silva, MD, MSc, Principal investigator, Faculty of Medicine from Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391105
- Sponsor's protocol ID
- ETIC 287/04
- Status last verified
- Oct 2006
- First submitted
- 19 Oct 2006
- Last updated
- 23 Oct 2006
- Results posted
- No
Publications
Pereira e Silva Y, Gomez RS, Barbosa RF, Simoes e Silva AC. Remifentanil for sedation and analgesia in a preterm neonate with respiratory distress syndrome. Paediatr Anaesth. 2005 Nov;15(11):993-6. doi: 10.1111/j.1460-9592.2005.01666.x.
PubMed 16238563
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Use of Remifentanil Versus Morphine for Sedation and Analgesia of Premature Neonates During Mechanical Ventilation in the Treatment of Respiratory Distress Syndrome (RDS)
- ClinicalTrials.gov ID
- NCT00391105
- Acronym / sponsor ID
- ETIC 287/04
- Conditions
- Respiratory Distress Syndrome
- Keywords
- intubation, Sedation, Analgesia, preterm neonate, remifentanil, morphine, respiratory distress syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Nov 2005
- First posted
- 23 Oct 2006 (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.
In this randomised controlled study we intended to compared intubation conditions and the continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated premature neonates (28-34wk) regarding the time to be awake and, the time until extubation after interruption of the opioid administration.
Detailed description
Intubation and mechanical ventilation are majors component of intensive care for premature neonates with respiratory distress syndrome (RDS) and is associated with physiologic, biochemical, and clinical responses indicating pain and stress in prematures. Although morphine is one of the most used drugs for premedication and for sedation and analgesia during mechanical ventilation in the treatment of RDS its pharmacological profile precludes several limitations mostly due to its much delayed onset of action what makes the drug not suitable as premedication and due to its prolonged duration of action mainly in prematures. Unlike morphine, remifentanil has an unique pharmacokinetic properties with a rapid onset of action and, a fast decrease in plasma concentration after interruption of administration due to a context-sensitive half-time of 3.2 minutes. So, it could be the ideal opioid for neonates who are especially sensitive to respiratory depression by opioids
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 minutes to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age between 28 and 34 wk
- Clinical and radiological features compatible with respiratory distress syndrome that required an elective tracheal intubation and surfactant therapy.
Key exclusion criteria (5 listed)
- The presence of major congenital malformations
- Birth weigh less than 1000g
- Previous or concurrent use of opioid for any reason (cesarean section with general anaesthesia)
- Hemodynamic instability before the indication of tracheal intubation
- Refuse of the parents to enroll the neonate in the study protocol
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 |
|---|---|---|
| Remifentanil | Drug | – |
Primary outcome
Intubation conditions using a four point scale
Decrease in time after interruption of sedation until the neonate be awake.
Decrease in time after interruption of sedation until the neonate be extubated.
2 secondary outcomes
Pain and stress before and after intubation (NIPS and Comfort scores).
Pain and stress during continuous infusion of remifentanil versus morphine during mechanical ventilation for the treatment of respiratory distress syndrome (NIPS and Comfort scores).
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 23 Oct 2006.
- Background: PubMed 16238563Pereira e Silva Y, Gomez RS, Barbosa RF, Simoes e Silva AC. Remifentanil for sedation and analgesia in a preterm neonate with respiratory distress syndrome. Paediatr Anaesth. 2005 Nov;15(11):993-6. doi: 10.1111/j.1460-9592.2005.01666.x.
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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, MD, MSc principal investigator
Faculty of Medicine from Federal University of Minas Gerais
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Remifentanil in people with Respiratory Distress Syndrome, run by Federal University of Minas Gerais.
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 23 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
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?
Intubation conditions using a four point scale. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00391105, which also lists 1 linked publication.
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 23 Oct 2006.