Clinical trial NCT05304598: Using Dexmedetomidine Prior to Intubation in Neonates
Official title: Randomized Case Control Study Using Dexmedetomidine Prior to Intubation in Neonates
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Effect Neonatal
Keywords: sedation
intubation
neonates
dexmedetomidine
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 0
Sex: ALL
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Oxygen Saturation Differences
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Alok Bhutada
role: PRINCIPAL_INVESTIGATOR
References: