Trial Outcomes & Findings for Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age (NCT NCT01508455)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

6 participants

Primary outcome timeframe

During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).

Results posted on

2017-08-23

Participant Flow

Neonatal subjects enrolled from 3 centers in the United States

Participant milestones

Participant milestones
Measure	Dexmedetomidine Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open-Label, Safety, and Efficacy Study of Dexmedetomidine in Preterm Subjects Ages ≥28 Weeks to <36 Weeks Gestational Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexmedetomidine n=6 Participants Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Age, Categorical <=18 years	6 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous Age Continuous	0.8 weeks STANDARD_DEVIATION 1.36 • n=93 Participants
Age, Continuous Age Continuous: units: Gestational Age	32.5 weeks STANDARD_DEVIATION 2.74 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Region of Enrollment United States	6 participants n=93 Participants

PRIMARY outcome

Timeframe: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).

Population: All Subjects who received study drug for at least 6 hours

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=6 Participants Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Percent of Subjects Requiring Rescue Midazolam for Sedation	0 percentage of participants

SECONDARY outcome

Timeframe: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).

Population: All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=6 Participants Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Incidence of Rescue Medication (Fentanyl or Morphine) Use for Analgesia During DEX Infusion	1 participant

SECONDARY outcome

Timeframe: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).

Population: No participants analyzed for this assessment since none required rescue Midazolam for sedation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: During the study drug administration (ie., loading dose 10 or 20 minutes and maintenance infusion minimum of 6 hours up to 24 hours) and during the post drug administration (up to 24 hours).

Population: Number of subject who received rescue medication for analgesia during DEX infusion

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=1 Participants Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Amount of Rescue Medication for Analgesia During DEX Infusion	1 mcg/kg

SECONDARY outcome

Timeframe: Predose, loading dose (LD) 5 & 10mins/if LD is 20mins (5, 10, 15 & 20mins); maintenance infusion: 0 min, every 15mins (1st hr); every 30mins (2hrs), then hourly; within 5mins of DEX discontinuation; 5mins pre and post rescue medication

Population: All subjects who received DEX for at least 6 hours formed the Efficacy Evaluable Population.

The N-PASS score \>3 indicates adequately sedated and not manifesting signs of pain/agitation.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=6 Participants Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Time Spent With a Total N-PASS Score >3 During DEX Infusion	0.44 Hours Standard Deviation 0.769

SECONDARY outcome

Timeframe: From the start of study drug infusion to the study completion/withdrawal (Approximately 48 hours)

Population: Subjects who had successful extubation alone (n=5) were included in this analysis.

Outcome measures

Outcome measures
Measure	Dexmedetomidine n=5 Participants Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Time to Successful Extubation	37.3 Hours Interval 23.083 to 97.833

Adverse Events

Dexmedetomidine

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Dexmedetomidine n=6 participants at risk Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
Gastrointestinal disorders Umbilcal hernia	16.7% 1/6 • Number of events 1 • Treatment Emergent Adverse Events Treatment Emergent defined as start of study drug to 24 hours after discontinuation of study drug
Metabolism and nutrition disorders Hypernatraenia	16.7% 1/6 • Number of events 1 • Treatment Emergent Adverse Events Treatment Emergent defined as start of study drug to 24 hours after discontinuation of study drug
Skin and subcutaneous tissue disorders Blister	16.7% 1/6 • Number of events 1 • Treatment Emergent Adverse Events Treatment Emergent defined as start of study drug to 24 hours after discontinuation of study drug

Additional Information

Dr. Marcelo Garcia da Rocha

Hospira

Phone: 224-212-4424

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place