Study Stopped
Not able to recruit patients due to lack of consent.
Using Dexmedetomidine Prior to Intubation in Neonates
Randomized Case Control Study Using Dexmedetomidine Prior to Intubation in Neonates
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
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Started Mar 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedStudy Start
First participant enrolled
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
March 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 20, 2024
CompletedMarch 28, 2025
March 1, 2025
2.4 years
March 14, 2022
March 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Oxygen Saturation Differences
Compare oxygen saturation differences between the control and study group
30 minutes
Study Arms (2)
Dexmedetomidine Group
ACTIVE COMPARATORa single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes
Control Group
ACTIVE COMPARATORroutine awake intubation as per current unit standard of care
Interventions
a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes
Eligibility Criteria
You may qualify if:
- neonates
- elective intubation
- admitted to the NICU
- Less than 44 weeks corrected gestational age requiring intubation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maimonides Medical Center
Brooklyn, New York, 11219, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alok Bhutada
Maimonides Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 14, 2022
First Posted
March 31, 2022
Study Start
March 14, 2022
Primary Completion
August 20, 2024
Study Completion
August 20, 2024
Last Updated
March 28, 2025
Record last verified: 2025-03