Premedication for Non-Emergency Endotracheal Intubation In the NICU

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Drug: Rocuronium; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Normal saline same amt as 0.6mg/kg of study drug
Active Comparator: Rocuronium; 0.6 mg/kg once	Drug: Rocuronium; 0.6 mg/Kg once; Other Names: Zemuron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Time Frame
Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.	24 hours after intubation procedure

Collaborators and Investigators

• Sponsor: Martin Espinosa, MD
• Collaborators: The Gerber Foundation
• Investigators: Principal Investigator: Martin Espinosa, MD, William Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: September 28, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimate): December 13, 2012

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: 2010-271

Drug and device information, study documents

• 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