Status:

WITHDRAWN

Using Dexmedetomidine Prior to Intubation in Neonates

Lead Sponsor:

Maimonides Medical Center

Conditions:

Effect Neonatal

Eligibility:

All Genders

Up to 120 years

Phase:

PHASE3

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 ...

Detailed Description

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 main...

Eligibility Criteria

Inclusion

  • neonates
  • elective intubation
  • admitted to the NICU
  • Less than 44 weeks corrected gestational age requiring intubation

Exclusion

  • 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

Key Trial Info

Start Date :

March 14 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 20 2024

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT05304598

Start Date

March 14 2022

End Date

August 20 2024

Last Update

March 28 2025

Active Locations (1)

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1

Maimonides Medical Center

Brooklyn, New York, United States, 11219