Trial Outcomes & Findings for tAN to Mitigate Withdrawal Behaviors in Neonates (NCT NCT04588519)

NCT ID: NCT04588519

Last Updated: 2022-12-28

Results Overview

No adverse events of bradycardia (HR \< 80 bpm), worsening of swallowing or feeding, skin irritation, or elevation of Neonatal Infant Pain Scores.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: 12 days
• Results posted on: 2022-12-28

Participant Flow

Participant milestones

Measure	Active Transcutaneous Auricular Neurostimulation tAN therapy was administered for 30 minutes one hour prior to morphine administration, up to four times per day, for up to 12 days (or discontinuation of morphine; whichever came first). The Spark Roo tAN System was programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

tAN to Mitigate Withdrawal Behaviors in Neonates

Baseline characteristics by cohort

Measure	Active Transcutaneous Auricular Neurostimulation n=8 Participants tAN therapy was administered for 30 minutes one hour prior to morphine administration, up to four times per day, for up to 12 days (or discontinuation of morphine; whichever came first). The Spark Roo tAN System was programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.
Age, Customized Gestational Age at Enrollment	38.2 weeks n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 days

No adverse events of bradycardia (HR < 80 bpm), worsening of swallowing or feeding, skin irritation, or elevation of Neonatal Infant Pain Scores.

Outcome measures

Measure

Active Transcutaneous Auricular Neurostimulation n=8 Participants tAN therapy was administered for 30 minutes one hour prior to morphine administration, up to four times per day, for up to 12 days (or discontinuation of morphine; whichever came first). The Spark Roo tAN System was programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.

Number of Subjects With no Adverse Events Related to Bradycardia (HR < 80 Bpm), Worsening of Swallowing or Feeding, Skin Irritation, or Elevation of Neonatal Infant Pain Scores.

7 Participants

PRIMARY outcome

Timeframe: 12 days

The Finnegan Scale assesses 31 of the most common signs of neonatal drug withdrawal syndrome and is scored on the basis of pathological significance and severity of the adverse symptoms. Scores for each sign are added to obtain a total score. Total scores range from 0-20, where lower scores are indicative of less severe signs of neonatal drug withdrawal symptoms.

Outcome measures

Measure

Active Transcutaneous Auricular Neurostimulation n=8 Participants tAN therapy was administered for 30 minutes one hour prior to morphine administration, up to four times per day, for up to 12 days (or discontinuation of morphine; whichever came first). The Spark Roo tAN System was programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.

Mean Finnegan Scores During Days of tAN Sessions

6.33 score on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: 12 days

Defined as the number of days between tAN therapy initiation and morphine discontinuation. A shorter duration of morphine weaning indicates better treatment efficacy.

Outcome measures

Measure

Active Transcutaneous Auricular Neurostimulation n=8 Participants tAN therapy was administered for 30 minutes one hour prior to morphine administration, up to four times per day, for up to 12 days (or discontinuation of morphine; whichever came first). The Spark Roo tAN System was programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.

Duration of Morphine Weaning

6.0 Days Interval 4.8 to 8.0

SECONDARY outcome

Timeframe: From participant birth to hospital discharge, a median of 17 days

Defined as the number of days between birth and discharge. A shorter length of stay indicates better treatment efficacy.

Outcome measures

Measure

Active Transcutaneous Auricular Neurostimulation n=8 Participants tAN therapy was administered for 30 minutes one hour prior to morphine administration, up to four times per day, for up to 12 days (or discontinuation of morphine; whichever came first). The Spark Roo tAN System was programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.

Length of Hospital Stay

17.0 Days Interval 15.3 to 28.5

Adverse Events

Active Transcutaneous Auricular Neurostimulation

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Active Transcutaneous Auricular Neurostimulation n=8 participants at risk tAN therapy was administered for 30 minutes one hour prior to morphine administration, up to four times per day, for up to 12 days (or discontinuation of morphine; whichever came first). The Spark Roo tAN System was programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.

Skin and subcutaneous tissue disorders Erythema

12.5% 1/8 • Number of events 2 • Through study completion (up to 12 days per participant)

Additional Information

Navid Khodaparast, PhD

Spark Biomedical, Inc.

Phone: 832-280-4756

Email: navid.khodaparast@sparkbiomedical.com

Results disclosure agreements

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