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Using Dexmedetomidine Prior to Intubation in Neonates

NCT05304598 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-03-28

No results posted yet for this study

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.

Conditions

  • Effect Neonatal

Interventions

DRUG

Dexmedetomidine

a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes

OTHER

Usual Care

routine awake intubation as per current unit standard of care,

Sponsors & Collaborators

  • Maimonides Medical Center

    lead OTHER

Principal Investigators

  • Alok Bhutada · Maimonides Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Days
Max Age
120 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2024-08-20
Completion
2024-08-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05304598 on ClinicalTrials.gov