Trial Outcomes & Findings for Premedication for Non-Emergency Endotracheal Intubation In the NICU (NCT NCT01749501)

NCT ID: NCT01749501

Last Updated: 2017-11-30

Results Overview

percentage of participants with an excellent ease of intubation rating based on Scale of 1-4 (1 Being Excellent, 4 Being Poor),"

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 45 participants
• Primary outcome timeframe: 24 hours after intubation period
• Results posted on: 2017-11-30

Participant Flow

69 participants consented but only 45 needed the study procedure

Participant milestones

Measure	Rocuronium 0.6 mg/kg once Rocuronium: 0.6 mg/Kg once	Placebo Placebo: Normal saline same amt as 0.6mg/kg of study drug
Overall Study STARTED	22	23
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Premedication for Non-Emergency Endotracheal Intubation In the NICU

Baseline characteristics by cohort

Measure	Rocuronium n=22 Participants 0.6 mg/kg once Rocuronium: 0.6 mg/Kg once	Placebo n=23 Participants Placebo: Normal saline same amt as 0.6mg/kg of study drug	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	35.4 post menstrual age (PMA) weeks STANDARD_DEVIATION 4.47 • n=5 Participants	33.88 post menstrual age (PMA) weeks STANDARD_DEVIATION 3.65 • n=7 Participants	34.62 post menstrual age (PMA) weeks STANDARD_DEVIATION 4.1 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	12 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 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),"

Outcome measures

Measure	Rocuronium n=22 Participants 0.6 mg/kg once Rocuronium: 0.6 mg/Kg once	Placebo n=23 Participants Placebo: Normal saline same amt as 0.6mg/kg of study drug
Present the Percentage of Participants With an Excellent Ease of Intubation Rating	91 % reported as excellent	17 % reported as excellent

SECONDARY outcome

Timeframe: 24 hours after intubation procedure

Outcome measures

Measure	Rocuronium n=22 Participants 0.6 mg/kg once Rocuronium: 0.6 mg/Kg once	Placebo n=23 Participants Placebo: Normal saline same amt as 0.6mg/kg of study drug
Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.	2.94 minutes Standard Deviation 5.0	4.95 minutes Standard Deviation 5.43

Adverse Events

Rocuronium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Martin Espinosa

William Beaumont Hospital

Phone: 248-898-0633

Email: Martin.espinosa@beaumont.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place