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| Name | Class |
|---|---|
| The Gerber Foundation | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocuronium | Active Comparator | 0.6 mg/kg once |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | 0.6 mg/Kg once |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)," | 24 hours after intubation period |
| Measure | Description | Time Frame |
|---|---|---|
| Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded. | 24 hours after intubation procedure |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Espinosa, MD | Corewell Health East | Principal Investigator |
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69 participants consented but only 45 needed the study procedure
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| ID | Title | Description |
|---|---|---|
| FG000 | Rocuronium | 0.6 mg/kg once Rocuronium: 0.6 mg/Kg once |
| FG001 | Placebo | Placebo: Normal saline same amt as 0.6mg/kg of study drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rocuronium | 0.6 mg/kg once Rocuronium: 0.6 mg/Kg once |
| BG001 | Placebo | Placebo: Normal saline same amt as 0.6mg/kg of study drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)," | Posted | Number | % reported as excellent | 24 hours after intubation period |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rocuronium | 0.6 mg/kg once Rocuronium: 0.6 mg/Kg once |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Martin Espinosa | William Beaumont Hospital | 248-898-0633 | Martin.espinosa@beaumont.edu |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo |
| Other |
Normal saline same amt as 0.6mg/kg of study drug |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | post menstrual age (PMA) weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded. | Posted | Mean | Standard Deviation | minutes | 24 hours after intubation procedure |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Placebo | Placebo: Normal saline same amt as 0.6mg/kg of study drug | 0 | 23 | 0 | 23 |
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| D011083 |
| Polycyclic Compounds |