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Premedication for Non-Emergency Endotracheal Intubation In the NICU

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Martin Espinosa, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01749501
First received: September 28, 2012
Last updated: December 11, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Respiratory Distress Syndrome
 Drug: Rocuronium
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Premedication for Non-Emergency Endotracheal Intubation In the NICU

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Intubator's perception of optimal intubation conditions (good jaw relaxation open and immobile vocal cords and suppression of gag reflex)based on scale of 1-4(1 being excellent, 4 being poor) [ Time Frame: 24 hours after intubation period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timing of entire procedure (stopwatch)and recording number of attempts to successful intubation recorded. [ Time Frame: 24 hours after intubation procedure ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rocorium
0.6 mg/kg once
 Drug: Rocuronium
0.6 mg/Kg once
Placebo Comparator: Placebo Other: Placebo
Normal saline same amt as 0.6mg/kg of study drug

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

  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

  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749501

Sponsors and Collaborators
Martin Espinosa, MD
The Gerber Foundation
Investigators
Principal Investigator: Martin Espinosa, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Martin Espinosa, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01749501     History of Changes
Other Study ID Numbers: 2010-271
Study First Received: September 28, 2012
Last Updated: December 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
 Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013