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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
Martin Espinosa, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

    First Posted
    September 28, 2012
    Last Updated
    October 24, 2017
    Sponsor
    Martin Espinosa, MD
    Collaborators
    The Gerber Foundation
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    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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