Premedication for Non-Emergency Endotracheal Intubation In the NICU
Primary Purpose
Respiratory Distress Syndrome
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Rocuronium
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rocuronium
Placebo
Arm Description
0.6 mg/kg once
Placebo
Outcomes
Primary Outcome Measures
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),"
Secondary Outcome Measures
Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.
Full Information
NCT ID
NCT01749501
First Posted
September 28, 2012
Last Updated
October 24, 2017
Sponsor
Martin Espinosa, MD
Collaborators
The Gerber Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01749501
Brief Title
Premedication for Non-Emergency Endotracheal Intubation In the NICU
Official Title
Premedication for Non-Emergency Endotracheal Intubation In the NICU
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Martin Espinosa, MD
Collaborators
The Gerber Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rocuronium
Arm Type
Active Comparator
Arm Description
0.6 mg/kg once
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Other Intervention Name(s)
Zemuron
Intervention Description
0.6 mg/Kg once
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Normal saline same amt as 0.6mg/kg of study drug
Primary Outcome Measure Information:
Title
Present the Percentage of Participants With an Excellent Ease of Intubation Rating
Description
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
Secondary Outcome Measure Information:
Title
Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.
Time Frame
24 hours after intubation procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
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
Exclusion criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Espinosa, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Premedication for Non-Emergency Endotracheal Intubation In the NICU
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