Using Dexmedetomidine Prior to Intubation in Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-14

Study Completion Date

2024-08-20

Brief Summary

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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.

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Detailed Description

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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 maintaining better oxygen saturations in neonates during intubation. The study will be done in the Neonatal Intensive Care Unit at Maimonides Medical Center.

Parents of babies requiring intubation will be approached by the Neonatal attending / fellow to obtain consent for the study. If a consent is obtained, babies will be randomized to a control or study group. Babies in the control group will undergo routine intubation by a neonatologist but with monitoring of the vital signs, those in the study group will receive the study drug 10 minutes prior to intubation.

Data Collection Procedures:

The research data will reside in an encrypted laptop issued by MIS that is housed in the Division of Newborn Medicine, within the medical center.

The data will be accessible to all researchers. If needed, de-identified data will be stored/shared on the Maimonides share point website for statistical and backup purposes.

The data that will be collected are heart rate, respiratory rate, oxygen saturation, measured continuously, and blood pressure measurement every five minutes. Data will be collected 15 minutes before, during and 30 minutes after intubation.

Conditions

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Effect Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Dexmedetomidine Group

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

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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

Control Group

routine awake intubation as per current unit standard of care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

routine awake intubation as per current unit standard of care,

Interventions

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Dexmedetomidine

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

Intervention Type DRUG

Usual Care

routine awake intubation as per current unit standard of care,

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

0 Days

Maximum Eligible Age

120 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes