Using Dexmedetomidine Prior to Intubation in Neonates

Study Overview
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Brief Summary
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Neonatal intubations are performed routinely in a NICU. Most intubations are still performed without the administration of medications (awake intubations). Some of the reasons are unavailability of a single good medication, the ease of administration, the physicians comfort level, side effects of medications including apnea, bradycardia, hypotension. Some units use a cocktail of different medications, each with their own side effects We are proposing to study the effects of a single medication, dexmedetomidine (precedex) for the purpose of sedation prior to intubation in neonates. This study will compare the efficacy of a single dose of dexmedetomidine to controls.

Detailed Description
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This is an interventional un-blinded, randomized, prospective pilot study to examine the efficacy of dexmedetomidine in reducing time to intubation, pain/discomfort associated with intubation and maintaining better oxygen saturations in neonates during intubation. The study will be done in the Neonatal Intensive Care Unit at Maimonides Medical Center. Parents of babies requiring intubation will be approached by the Neonatal attending / fellow to obtain consent for the study. If a consent is obtained, babies will be randomized to a control or study group. Babies in the control group will undergo routine intubation by a neonatologist but with monitoring of the vital signs, those in the study group will receive the study drug 10 minutes prior to intubation. Data Collection Procedures: The research data will reside in an encrypted laptop issued by MIS that is housed in the Division of Newborn Medicine, within the medical center. The data will be accessible to all researchers. If needed, de-identified data will be stored/shared on the Maimonides share point website for statistical and backup purposes. The data that will be collected are heart rate, respiratory rate, oxygen saturation, measured continuously, and blood pressure measurement every five minutes. Data will be collected 15 minutes before, during and 30 minutes after intubation.

Official Title
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Randomized Case Control Study Using Dexmedetomidine Prior to Intubation in Neonates

Conditions
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Effect Neonatal

Intervention / Treatment
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* Drug: Dexmedetomidine
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neonates elective intubation admitted to the NICU Less than 44 weeks corrected gestational age requiring intubation Exclusion Criteria: babies requiring emergent intubation Neonates with birth weight<1250 grams and <1 week of postnatal age Neonates with major congenital malformations Neonates with preexisting hypotension (MAP < Gest Age) Neonates with complex congenital heart disease and heart block

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 120 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine Group<br>a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes | Drug: Dexmedetomidine<br>* a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes<br>|
| Active Comparator: Control Group<br>routine awake intubation as per current unit standard of care | Other: Usual Care<br>* routine awake intubation as per current unit standard of care,<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation Differences | Compare oxygen saturation differences between the control and study group | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedation, intubation, neonates, dexmedetomidine