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Premedication for Non-Emergency Endotracheal Intubation In the NICU

NCT01749501 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-11-30

Study results available
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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

Interventions

DRUG

Rocuronium

0.6 mg/Kg once

OTHER

Placebo

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

Sponsors & Collaborators

  • The Gerber Foundation

    collaborator OTHER

  • Martin Espinosa, MD

    lead OTHER

Principal Investigators

  • Martin Espinosa, MD · William Beaumont Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2014-01-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01749501 on ClinicalTrials.gov