Using Dexmedetomidine Prior to Intubation in Neonates

Randomized Case Control Study Using Dexmedetomidine Prior to Intubation in Neonates

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.

Study Overview

• Status: Recruiting
• Conditions: Effect Neonatal
• Intervention / Treatment: Drug: Dexmedetomidine; Other: Usual Care

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Alok Bhutada, MD; Phone Number: 718-283-8853; Email: abhutada@maimonidesmed.org
• Study Contact Backup: Name: Anju Gupta-Modak, MD; Phone Number: 718-283-8853; Email: agupta@maimonidesmed.org

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Recruiting
      • Maimonides Medical Center
      • Contact: Alok Bhutada, MD; Email: abhutada@Maimonidesmed.org
      • Contact: Anju Gupta-Modak, MD; Email: agupta@maimonidesmed.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 months (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine Group; a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes	Drug: Dexmedetomidine; a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes
Active Comparator: Control Group; routine awake intubation as per current unit standard of care	Other: Usual Care; routine awake intubation as per current unit standard of care,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen Saturation Differences	Compare oxygen saturation differences between the control and study group	30 minutes

Collaborators and Investigators

• Sponsor: Maimonides Medical Center
• Investigators: Principal Investigator: Alok Bhutada, Maimonides Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 14, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: dexmedetomidine; sedation; neonates; intubation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: 2021-03-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No