Respiratory Distress Syndrome
Conditions
Brief 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. 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
Interventions
DRUGRocuronium
0.6 mg/Kg once
OTHERPlacebo
Normal saline same amt as 0.6mg/kg of study drug
Sponsors
The Gerber Foundation
Martin Espinosa, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Infants admitted to the NICU at Beaumont Children's Hospital Royal Oak and Troy. 2. Gestational Age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher 3. Infants who require endotracheal intubation on a non-emergent basis 4. Signed informed consent by parents
Exclusion criteria
1. intubations that occurred in the delivery room or for other emergent basis, 2. absence of intravenous access 3. abnormality of the airway 4. known or family history of neuromuscular disorder 5. renal insufficiency (urine output \<0.6 mL/kg per hour or creatine \>1.7 mg/dL if \> 1 day of age) 6. known hepatic insufficiency (abnormal liver function or coagulation laboratory results) 7. Current diagnosis of pulmonary hypertension 8. Any infant deemed by the attending neonatologist as unstable or unfit for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Present the Percentage of Participants With an Excellent Ease of Intubation Rating | 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), |
Secondary
| Measure | Time frame |
|---|---|
| Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded. | 24 hours after intubation procedure |
Participant flow
Recruitment details
69 participants consented but only 45 needed the study procedure
Participants by arm
| Arm | Count |
|---|---|
| Rocuronium 0.6 mg/kg once
Rocuronium: 0.6 mg/Kg once | 22 |
| Placebo Placebo: Normal saline same amt as 0.6mg/kg of study drug | 23 |
| Total | 45 |
Baseline characteristics
| Characteristic | Placebo | Rocuronium | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 23 Participants | 22 Participants | 45 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 33.88 post menstrual age (PMA) weeks STANDARD_DEVIATION 3.65 | 35.4 post menstrual age (PMA) weeks STANDARD_DEVIATION 4.47 | 34.62 post menstrual age (PMA) weeks STANDARD_DEVIATION 4.1 |
| Region of Enrollment United States | 23 participants | 22 participants | 45 participants |
| Sex: Female, Male Female | 11 Participants | 9 Participants | 20 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 23 |
| serious Total, serious adverse events | 0 / 22 | 0 / 23 |
Outcome results
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),
Time frame: 24 hours after intubation period
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rocuronium | Present the Percentage of Participants With an Excellent Ease of Intubation Rating | 91 % reported as excellent |
| Placebo | Present the Percentage of Participants With an Excellent Ease of Intubation Rating | 17 % reported as excellent |
Secondary
Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.
Time frame: 24 hours after intubation procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rocuronium | Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded. | 2.94 minutes | Standard Deviation 5 |
| Placebo | Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded. | 4.95 minutes | Standard Deviation 5.43 |