Premedication for Non-Emergency Endotracheal Intubation In the NICU

• ClinicalTrials.gov Identifier: NCT01749501
• Recruitment Status: Completed
• First Posted: December 13, 2012
• Results First Posted: June 22, 2015
• Last Update Posted: November 30, 2017
• Sponsor: Martin Espinosa, MD
• Collaborator: The Gerber Foundation
• Information provided by (Responsible Party): Martin Espinosa, MD, William Beaumont Hospitals

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.

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

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Rocuronium; 0.6 mg/kg once	Drug: Rocuronium; 0.6 mg/Kg once; Other Name: Zemuron
Placebo Comparator: Placebo; Placebo	Other: Placebo; Normal saline same amt as 0.6mg/kg of study drug

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

Martin Espinosa, MD

The Gerber Foundation

Investigators

• Principal Investigator: Martin Espinosa, MD; William Beaumont Hospitals

More Information

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

• 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:

Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; 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