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Alpha-2 Agonist
Dexmedetomidine for Neonatal Sedation
Phase 3
Recruiting
Led By Alok Bhutada
Research Sponsored by Maimonides Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neonates requiring elective intubation
Neonates less than 44 weeks corrected gestational age requiring intubation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Study Summary
This trial will study the effects of dexmedetomidine given as a single dose for the purpose of sedation prior to intubation in neonates.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests whether dexmedetomidine (precedex) is effective as sedation before putting a tube in a baby's windpipe compared to usual care without medication. Babies will be randomly assigned to receive either the drug or no sedative.See study design
What are the potential side effects?
Dexmedetomidine may cause slower heart rate (bradycardia), lower blood pressure (hypotension), and could lead to pauses in breathing (apnea). These side effects are particularly monitored due to the vulnerability of neonates.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My newborn needs a planned breathing tube insertion.
Select...
My newborn requires breathing support and is under 44 weeks in corrected gestational age.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Oxygen Saturation Differences
Trial Design
2Treatment groups
Active Control
Group I: Control GroupActive Control1 Intervention
routine awake intubation as per current unit standard of care
Group II: Dexmedetomidine GroupActive Control1 Intervention
a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes
Find a Location
Who is running the clinical trial?
Maimonides Medical CenterLead Sponsor
69 Previous Clinical Trials
15,265 Total Patients Enrolled
Alok BhutadaPrincipal InvestigatorMaimonides Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My newborn needs a planned breathing tube insertion.My newborn has a complex heart condition and heart block.My newborn weighs less than 1250 grams and is under 1 week old.My newborn needs immediate help to breathe.My newborn has lower than expected blood pressure for their age.My newborn requires breathing support and is under 44 weeks in corrected gestational age.My newborn has significant birth defects.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Dexmedetomidine Group
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study have specific requirements for participants?
"This study is for neonates that are 0-120 days old. There are 30 total spots available for this trial."
Answered by AI
Are elderly individuals eligible for this research program?
"This experiment is taking in patients that are less than 120 days old and more than 0 days old."
Answered by AI
How does the Dexmedetomidine Group's safety record compare to other patients?
"There is some evidence, from Phase 3 trials, to support the efficacy of Dexmedetomidine. Furthermore, there have been multiple rounds of clinical trials that suggest this intervention is safe. Consequently, we've given it a score of 3."
Answered by AI
Are there still unfilled positions for people who want to participate in this research?
"The clinical trial is still open and recruiting patients, as indicated by the listing on clinicaltrials.gov. This study was first posted on 3/14/2022 and updated less than 2 weeks ago on 3/30/2022."
Answered by AI
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