Using Dexmedetomidine Prior to Intubation in Neonates

Phase 3

Recruiting

• Conditions: Effect Neonatal
• Interventions: Other: Usual Care; Drug: Dexmedetomidine

• Registration Number: NCT05304598
• Lead Sponsor: Maimonides Medical Center

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.

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 Timeline

• Study Start: 2022-03-14
• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-03-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Usual Care	routine awake intubation as per current unit standard of care
Dexmedetomidine Group	Dexmedetomidine	a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes

Primary Outcome Measures

Name	Time	Method
Oxygen Saturation Differences	30 minutes	Compare oxygen saturation differences between the control and study group

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States