Respiratory Distress SyndromePhase 4NCT01749501
Premedication for Non-Emergency Endotracheal Intubation In the NICU
A Phase 4 study testing Rocuronium in people with Respiratory Distress Syndrome, run by Martin Espinosa, MD.
Trial summary
Those infants who received the muscle relaxation in combination with the vagolytic (reduce vagus nerve impulses) and pain medication will have reduced time to successful intubation (placement of tube into the lungs), a decrease in the number of attempts, and better intubation conditions reported by the practitioner. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- Rocuronium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants admitted to the NICU at Beaumont Children's Hospital Royal Oak and Troy.
- Gestational Age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher
- Infants who require endotracheal intubation on a non-emergent basis
- Signed informed consent by parents
Who cannot join
- intubations that occurred in the delivery room or for other emergent basis,
- absence of intravenous access
- abnormality of the airway
- known or family history of neuromuscular disorder
- renal insufficiency (urine output <0.6 mL/kg per hour or creatine >1.7 mg/dL if > 1 day of age)
- known hepatic insufficiency (abnormal liver function or coagulation laboratory results)
- Current diagnosis of pulmonary hypertension
- Any infant deemed by the attending neonatologist as unstable or unfit for the study
About this study
Those infants who received the muscle relaxation in combination with the vagolytic (reduce vagus nerve impulses) and pain medication will have reduced time to successful intubation (placement of tube into the lungs), a decrease in the number of attempts, and better intubation conditions reported by the practitioner. The objectives of the study include: 1.) Does the medication protocol outlined in this study provide optimal intubation conditions? (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.) Does the addition of a muscle relaxant prior to intubation contribute to less attempts and achieving successful intubation as opposed to neonates who do not receive the muscle relaxant.
Read the detailed description
The investigators project will study two different strategies of pre-medication in an attempt to eliminate the pain and discomfort associated with the elective intubation procedure. The study will be blinded and patients will be randomized in two different arms according to gestational age and identified by study number for pre-medication protocols. Demographic as well as study information prior, during and post intubation attempt will be recorded and closely monitored. Each patient will be monitored for study purposes for at least 24 hours after intubation attempt to record any potential side effects of the medication. The investigators plan to have a data safety monitoring board established composed of three pediatric doctors / specialists not associated with this study.
The response of paralysis, onset and duration will be assessed clinically. Onset of muscle relaxation will be described as the absence of spontaneous movements and flaccidity, measured in seconds from the end of the medication administration. Duration of paralysis will be determined by the difference in time from the onset of paralysis to the return of spontaneous movements and pre-intubation tone
- Conditions
- Respiratory Distress Syndrome
- Being tested
- Rocuronium, Placebo
- 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.
RocuroniumDrug
Also called Zemuron
0.6 mg/Kg once
PlaceboOther
Normal saline same amt as 0.6mg/kg of study drug
| Study group | Role | What they receive |
|---|---|---|
| Rocuronium | Active comparator | 0.6 mg/kg once Receives: Drug: Rocuronium |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Present the Percentage of Participants With an Excellent Ease of Intubation Rating
percentage of participants with an excellent ease of intubation rating based on Scale of 1-4 (1 Being Excellent, 4 Being Poor),"
Measured: 24 hours after intubation period
Secondary outcomes (1)
Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.
Measured: 24 hours after intubation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin Espinosa, MD
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Sponsor-investigator, Martin Espinosa, MD, Corewell Health East
- Investigators
- Martin Espinosa, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749501
- Sponsor's protocol ID
- 2010-271
- Status last verified
- Oct 2017
- First submitted
- 28 Sep 2012
- Last updated
- 30 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Premedication for Non-Emergency Endotracheal Intubation In the NICU
- ClinicalTrials.gov ID
- NCT01749501
- Acronym / sponsor ID
- 2010-271
- Conditions
- Respiratory Distress Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Martin Espinosa, MDUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 22 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Those infants who received the muscle relaxation in combination with the vagolytic (reduce vagus nerve impulses) and pain medication will have reduced time to successful intubation (placement of tube into the lungs), a decrease in the number of attempts, and better intubation conditions reported by the practitioner. The objectives of the study include: 1.) Does the medication protocol outlined in this study provide optimal intubation conditions? (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.) Does the addition of a muscle relaxant prior to intubation contribute to less attempts and achieving successful intubation as opposed to neonates who do not receive the muscle relaxant.
Detailed description
The investigators project will study two different strategies of pre-medication in an attempt to eliminate the pain and discomfort associated with the elective intubation procedure. The study will be blinded and patients will be randomized in two different arms according to gestational age and identified by study number for pre-medication protocols. Demographic as well as study information prior, during and post intubation attempt will be recorded and closely monitored. Each patient will be monitored for study purposes for at least 24 hours after intubation attempt to record any potential side effects of the medication. The investigators plan to have a data safety monitoring board established composed of three pediatric doctors / specialists not associated with this study.
The response of paralysis, onset and duration will be assessed clinically. Onset of muscle relaxation will be described as the absence of spontaneous movements and flaccidity, measured in seconds from the end of the medication administration. Duration of paralysis will be determined by the difference in time from the onset of paralysis to the return of spontaneous movements and pre-intubation tone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rocuronium | Active comparator | Drug: Rocuronium0.6 mg/kg once |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Infants admitted to the NICU at Beaumont Children's Hospital Royal Oak and Troy.
- Gestational Age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher
- Infants who require endotracheal intubation on a non-emergent basis
- Signed informed consent by parents
Key exclusion criteria (8 listed)
- intubations that occurred in the delivery room or for other emergent basis,
- absence of intravenous access
- abnormality of the airway
- known or family history of neuromuscular disorder
- renal insufficiency (urine output <0.6 mL/kg per hour or creatine >1.7 mg/dL if > 1 day of age)
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 |
|---|---|---|
| RocuroniumAlso: Zemuron0.6 mg/Kg once | Drug | Rocuronium |
| PlaceboNormal saline same amt as 0.6mg/kg of study drug | Other | Placebo |
Primary outcome
Present the Percentage of Participants With an Excellent Ease of Intubation Rating
Time frame: 24 hours after intubation period
percentage of participants with an excellent ease of intubation rating based on Scale of 1-4 (1 Being Excellent, 4 Being Poor),"
1 secondary outcome
Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.
Time frame: 24 hours after intubation procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Martin Espinosa, MD principal investigator
Corewell Health East
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rocuronium in people with Respiratory Distress Syndrome, run by Martin Espinosa, MD.
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 4 inclusion and 8 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 30 Nov 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Present the Percentage of Participants With an Excellent Ease of Intubation Rating (time frame: 24 hours after intubation period). 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 30 Nov 2017.