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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
Must not have
Neonates with complex congenital heart disease and heart block
Neonates with birth weight <1250 grams and <1 week of postnatal age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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 below
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My newborn needs a planned breathing tube insertion.
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My newborn requires breathing support and is under 44 weeks in corrected gestational age.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My newborn has a complex heart condition and heart block.
Select...
My newborn weighs less than 1250 grams and is under 1 week old.
Select...
My newborn needs immediate help to breathe.
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My newborn has lower than expected blood pressure for their age.
Select...
My newborn has significant birth defects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oxygen Saturation Differences

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.

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
71 Previous Clinical Trials
15,480 Total Patients Enrolled
Alok BhutadaPrincipal InvestigatorMaimonides Medical Center

Media Library

Dexmedetomidine (Alpha-2 Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05304598 — Phase 3
Neonatal Effects Research Study Groups: Control Group, Dexmedetomidine Group
Neonatal Effects Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT05304598 — Phase 3
Dexmedetomidine (Alpha-2 Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05304598 — Phase 3
~16 spots leftby Dec 2027
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