Using Dexmedetomidine Prior to Intubation in Neonates

Maimonides Medical Center

Status and phase: Withdrawn; Phase 3

Conditions: Effect Neonatal

Treatments: Drug: Dexmedetomidine; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05304598

2021-03-05

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 120 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Dexmedetomidine Group

Active Comparator group

Description:

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

Treatment:

Drug: Dexmedetomidine

Control Group

Active Comparator group

Description:

routine awake intubation as per current unit standard of care

Treatment:

Other: Usual Care