Premedication for Non-Emergency Endotracheal Intubation In the NICU

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.

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Key information

Conditions

Respiratory Distress Syndrome Lung Diseases Respiration Disorders Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

0.6 mg/Kg once

Other names: Zemuron

Placebo

Other

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

Primary outcomes

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 outcomes

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

Time frame: 24 hours after intubation procedure

Sponsors and collaborators

Lead sponsor

Martin Espinosa, MD

Other

Collaborators

The Gerber Foundation

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2014
First posted: Dec 13, 2012
Registry last updated: Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed