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Premedication for Non-Emergency Endotracheal Intubation In the NICU

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749501
Recruitment Status : Completed
First Posted : December 13, 2012
Results First Posted : June 22, 2015
Last Update Posted : November 30, 2017
The Gerber Foundation
Information provided by (Responsible Party):
Martin Espinosa, MD, William Beaumont Hospitals

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Drug: Rocuronium Other: Placebo Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Premedication for Non-Emergency Endotracheal Intubation In the NICU
Study Start Date : January 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Active Comparator: Rocuronium
0.6 mg/kg once
Drug: Rocuronium
0.6 mg/Kg once
Other Name: Zemuron

Placebo Comparator: Placebo
Other: Placebo
Normal saline same amt as 0.6mg/kg of study drug

Primary Outcome Measures :
  1. Present the Percentage of Participants With an Excellent Ease of Intubation Rating [ Time Frame: 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),"

Secondary Outcome Measures :
  1. Timing of Entire Procedure (Stopwatch)and Recording Number of Attempts to Successful Intubation Recorded. [ Time Frame: 24 hours after intubation procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01749501

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

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Responsible Party: Martin Espinosa, MD, Principal Investigator, William Beaumont Hospitals Identifier: NCT01749501    
Other Study ID Numbers: 2010-271
First Posted: December 13, 2012    Key Record Dates
Results First Posted: June 22, 2015
Last Update Posted: November 30, 2017
Last Verified: October 2017

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