A Phase 3 interventional study of Dexmedetomidine and Usual Care in Effect Neonatal, sponsored by Maimonides Medical Center. Withdrawn at 1 site in United States. Open to participants aged 0 Days to 120 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Maimonides Medical Center · Phase 3, Interventional, and Supportive care
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.
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.
Maimonides Medical Center is the lead sponsor of 50 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes
Drug: Dexmedetomidine
routine awake intubation as per current unit standard of care
Other: Usual Care
a single intravenous (i.v.) dose of dexmedetomidine, 0.2 mcg/kg over 10 minutes
routine awake intubation as per current unit standard of care,
Oxygen Saturation Differences
Compare oxygen saturation differences between the control and study group
Time frame: 30 minutes
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Mar 2022 to primary completion in Aug 2024, 29 months.
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This study is withdrawn, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
Maimonides Medical Center