Using Dexmedetomidine Prior to Intubation in Neonates

Sponsor

Maimonides Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05304598

Collaborator

(none)

Enrollment

Location

Arms

69.6

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Effect Neonatal	Drug: Dexmedetomidine Other: Usual Care	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Randomized Case Control Study Using Dexmedetomidine Prior to Intubation in Neonates

Actual Study Start Date :

Mar 14, 2022

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2027

Arms and Interventions

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,

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,

Outcome Measures

Primary Outcome Measures

Oxygen Saturation Differences [30 minutes]
Compare oxygen saturation differences between the control and study group

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 120 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maimonides Medical Center	Brooklyn	New York	United States	11219

Sponsors and Collaborators

Maimonides Medical Center

Investigators

Principal Investigator: Alok Bhutada, Maimonides Medical Center

Study Documents (Full-Text)

Study Protocol and Statistical Analysis Plan - Aug 11, 2020

More Information

Publications

None provided.

Responsible Party:

Alok Bhutada, Principal Investigator, Maimonides Medical Center

ClinicalTrials.gov Identifier:

NCT05304598

Other Study ID Numbers:

2021-03-05

First Posted:

Mar 31, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Alok Bhutada, Principal Investigator, Maimonides Medical Center

Additional relevant MeSH terms:

Dexmedetomidine

Study Results

No Results Posted as of Mar 31, 2022