Dexmedetomidine for Neonatal Sedation
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
Is dexmedetomidine safe for use in neonates and children?
Dexmedetomidine has been shown to be safe in the short term for neonates and children, with common side effects including slow heart rate (bradycardia) and low blood pressure (hypotension). It is well-tolerated in pediatric patients for sedation during procedures, but more studies are needed to understand its long-term safety.12345
How is the drug Dexmedetomidine unique for neonatal sedation?
Dexmedetomidine is unique for neonatal sedation because it works by activating certain receptors in the brain that help calm and sedate without causing significant respiratory depression, which is a common risk with other sedatives. This makes it potentially safer for use in newborns compared to traditional sedatives.678910
What data supports the effectiveness of the drug Dexmedetomidine for neonatal sedation?
Dexmedetomidine has been shown to provide effective sedation in children undergoing procedures, allowing them to breathe on their own without needing a breathing tube. It is also used safely in pediatric patients for various procedures, providing smooth sedation with minimal breathing issues.2451112
Who Is on the Research Team?
Alok Bhutada, MD
Principal Investigator
Maimonides Medical Center
Are You a Good Fit for This Trial?
This trial is for neonates admitted to the NICU who need elective intubation and are less than 44 weeks corrected gestational age. It's not for babies under 1250 grams or less than a week old, those with major birth defects, preexisting low blood pressure (MAP < Gest Age), complex heart issues, or if they need emergency intubation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous dose of dexmedetomidine or undergo routine awake intubation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dexmedetomidine
Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Maimonides Medical Center
Lead Sponsor