NCT05304598

Using Dexmedetomidine Prior to Intubation in Neonates

Randomized Case Control Study Using Dexmedetomidine Prior to Intubation in Neonates

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Maimonides Medical Center · Academic / Other
• Sex: All
• Age: 0 Days – 120 Days
• Healthy volunteers: Accepted

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.

Conditions

• Effect Neonatal

Interventions

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

Timeline

• Start date: 2022-03-14
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2022-03-31
• Last updated: 2025-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study