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Premedication for Non-Emergency Endotracheal Intubation In the NICU

NCT ID: NCT01749501

Last Updated: 2017-11-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-01-31

Brief Summary

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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

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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

Conditions

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Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Rocuronium

0.6 mg/kg once

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

0.6 mg/Kg once

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Rocuronium

0.6 mg/Kg once

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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Zemuron

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Gerber Foundation

OTHER

Sponsor Role collaborator

Martin Espinosa, MD

OTHER

Sponsor Role lead

Responsible Party

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Martin Espinosa, MD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Martin Espinosa, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Other Identifiers

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2010-271

Identifier Type: -

Identifier Source: org_study_id