Premedication for Non-Emergency Endotracheal Intubation In the NICU

NCT01749501 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2010-271
• Study Type: interventional
• Target: 45
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded.

  24 hours after intubation procedure

Study Arms (2)

Rocuronium

ACTIVE COMPARATOR

0.6 mg/kg once

Drug: Rocuronium

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Rocuronium DRUG

0.6 mg/Kg once

Also known as: Zemuron

Rocuronium

Placebo OTHER

Normal saline same amt as 0.6mg/kg of study drug

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin Espinosa, MD: lead
• The Gerber Foundation: collaborator

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Martin Espinosa
• Organization: William Beaumont Hospital

Martin.espinosa@beaumont.edu

248-898-0633

Study Officials

• Martin Espinosa, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: December 13, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: November 30, 2017
• Results First Posted: June 22, 2015

Record last verified: 2017-10