Trial Outcomes & Findings for Clonidine for Neonatal Abstinence Syndrome Study (NCT NCT01175668)

NCT ID: NCT01175668

Last Updated: 2014-01-06

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: subjects were followed for the duration of treatment, up to 3 months
• Results posted on: 2014-01-06

Participant Flow

The study was conducted at Baystate Children's Hospital Davis Neonatal Intensive Care Unit (NICU), a level III, regional perinatal referral center, for Western Massachusetts, from June 2010 to June 2012

Overall 82 infants were consented for the study but 14 were excluded either because they did not have continued high modified Finnegan Scores (n=13), or had Unstable clinical status (n=1)

Participant milestones

Measure	NMS/Clonidine Dosing was based on the Finnegan scores as below Finn Score 8-10 NMS 0.32mg/kg/day + Clonidine 6 mcg/kg/day 11-13 NMS 0.48 mg/kg/day + Clonidine 8 mcg/kg/day 14-16 NMS 0.64 mg/kg/day + Clonidine 10 mcg/kg/day ≥17 NMS 0.8 mg/kg/day\* + Clonidine 12 mcg/kg/day Daily NMS dose was divided for q3h dosing interval Daily Clonidine dose was divided for q6h dosing interval Clonidine escalation may be limited by hypotension or bradycardia \*If needing morphine sulfate \> 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score \< 8	NMS/Phenobarbital Dosing was based on the Finnegan scores as below Finn Score 8-10 NMS 0.32mg/kg/day +Phenobarbital 6 mg/kg/day 11-13 NMS 0.48 mg/kg/day +Phenobarbital 8 mg/kg/day 14-16 NMS 0.64 mg/kg/day +Phenobarbital 10 mg/kg/day ≥17 NMS 0.8 mg/kg/day\* + Phenobarbital 12 mg/kg/day Daily NMS dose was divided for q3h dosing interval Daily Phenobarbital dose was divided for q8h dosing interval \*If needing morphine sulfate \> 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score \< 8
Overall Study STARTED	34	34
Overall Study COMPLETED	32	34
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	NMS/Clonidine Dosing was based on the Finnegan scores as below Finn Score 8-10 NMS 0.32mg/kg/day + Clonidine 6 mcg/kg/day 11-13 NMS 0.48 mg/kg/day + Clonidine 8 mcg/kg/day 14-16 NMS 0.64 mg/kg/day + Clonidine 10 mcg/kg/day ≥17 NMS 0.8 mg/kg/day\* + Clonidine 12 mcg/kg/day Daily NMS dose was divided for q3h dosing interval Daily Clonidine dose was divided for q6h dosing interval Clonidine escalation may be limited by hypotension or bradycardia \*If needing morphine sulfate \> 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score \< 8	NMS/Phenobarbital Dosing was based on the Finnegan scores as below Finn Score 8-10 NMS 0.32mg/kg/day +Phenobarbital 6 mg/kg/day 11-13 NMS 0.48 mg/kg/day +Phenobarbital 8 mg/kg/day 14-16 NMS 0.64 mg/kg/day +Phenobarbital 10 mg/kg/day ≥17 NMS 0.8 mg/kg/day\* + Phenobarbital 12 mg/kg/day Daily NMS dose was divided for q3h dosing interval Daily Phenobarbital dose was divided for q8h dosing interval \*If needing morphine sulfate \> 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score \< 8
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Clonidine for Neonatal Abstinence Syndrome Study

Baseline characteristics by cohort

Measure	NMS/Clonidine n=34 Participants	NMS/Phenobarbital n=34 Participants	Total n=68 Participants Total of all reporting groups
Age Continuous	1.8 days STANDARD_DEVIATION 0.9 • n=5 Participants	2.26 days STANDARD_DEVIATION 1.60 • n=7 Participants	2.05 days STANDARD_DEVIATION 1.32 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: subjects were followed for the duration of treatment, up to 3 months

Outcome measures

Measure	NMS/Clonidine n=32 Participants	NMS/Phenobarbital n=34 Participants
Length of Treatment With Neonatal Morphine Sulfate	18.2 days Interval 14.9 to 21.5	13.6 days Interval 11.0 to 16.1

SECONDARY outcome

Timeframe: For the duration of treatment, upto 3 months

Outcome measures

Measure	NMS/Clonidine n=32 Participants	NMS/Phenobarbital n=34 Participants
Total Dose of NMS Used	5.7 mg/kg Interval 4.7 to 6.8	4.6 mg/kg Interval 3.8 to 5.4

Adverse Events

NMS/Clonidine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

NMS/Phenobarbital

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	NMS/Clonidine n=34 participants at risk	NMS/Phenobarbital n=34 participants at risk
Nervous system disorders Oversedation	0.00% 0/34 • During the hospital stay In the phenobarbital group, 3 infants (8.8%), manifested over sedation signs (poor feeds, and mild respiratory depression). This prompted serum phenobarbital measurements which were noted to be supra-therapeutic (\>40 mg/dL) and required dosage adjustment.	8.8% 3/34 • Number of events 3 • During the hospital stay In the phenobarbital group, 3 infants (8.8%), manifested over sedation signs (poor feeds, and mild respiratory depression). This prompted serum phenobarbital measurements which were noted to be supra-therapeutic (\>40 mg/dL) and required dosage adjustment.

Additional Information

Rachana Singh, MD

Baystate Medical Center

Phone: 413-794-2400

Email: rachana.singhmd@bhs.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place