Trial Outcomes & Findings for BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding (NCT NCT04849507)

Last Updated: 2025-10-28

Results Overview

safety : number of participants with episode of Heart rate \< 80beats per minute for 5 seconds, according to the first assigned treatment

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

30 minutes during taVNS paired-feed for 10 days

Results posted on

2025-10-28

Participant Flow

recruitment in the neonatal intensive care unit MUSC from 8/1/22 to 5/30/24

n=1 participant made rapid advance in feeds during screening studies prior to receiving any assigned treatment; Design includes a cross-over to alternative blinded treatment if feeding volume increase was \<4ml/kg/d \*participants only cross over between Active and Sham treatments within the same location

Participant milestones

Participant milestones
Measure	active taVNS unit tragus/ cymba conchae We will deliver taVNS via the taVNS unit with the ear electrode positioned on left tragus or at the cymba conchae with return to the tragus. Pulses are paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	sham taVNS unit tragus/cymbae conchae We will deliver inactive /sham taVNS via the taVNS unit with the ear electrode positioned around left cymba conchae/ inner tragus with return to the outer tragus. No pulses are delivered when pressing trigger, paired with oral feeding during 2 feeds a day. No current will be delivered, and assignment will be blinded. transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Active taVNS unit cymba conchae/mastoid We will deliver taVNS via the taVNS unit on the vagus channel with the ear electrode positioned around left cymba conchae with return to the mastoid. Pulses are paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Sham taVNS unit cymbae conchae/mastoid We will deliver inactive /sham taVNS via the aVNS unit on the vagus channel with the ear electrode positioned around left cymba conchae with return to the mastoid. No pulses are delivered when pressing trigger, paired with oral feeding during 2 feeds a day. No current will be delivered, and assignment will be blinded. transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Active taVNs crossover to sham taVNS infants who received 10 days of active taVNS but had \<4ml/kg/d of oral feeding increase and crossed over the alternative treatment of sham taVNS	Sham taVNS cross over to active taVNS infants who received 10 days of sham taVNS and had \<4ml/kg/d of oral feeding increase and crossed over the alternative treatment of active taVNS
Overall Study STARTED	5	3	2	2	2	2
Overall Study cross over to alternate treatment	0	0	0	0	2	2
Overall Study COMPLETED	5	3	2	2	2	2
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BabyStrong Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Paired Bottle Feeding to Improve Oral Feeding

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	active taVNS unit tragus/ cymba conchae n=5 Participants We will deliver taVNS via the taVNS unit with the ear electrode positioned on left tragus or at the cymba conchae with return to the tragus. Pulses are paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	sham taVNS unit tragus/cymbae conchae n=3 Participants We will deliver inactive /sham taVNS via the taVNS unit with the ear electrode positioned around left cymba conchae/ inner tragus with return to the outer tragus. No pulses are delivered when pressing trigger, paired with oral feeding during 2 feeds a day. No current will be delivered, and assignment will be blinded. transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Active taVNS unit cymba conchae/mastoid n=2 Participants We will deliver taVNS via the taVNS unit on the vagus channel with the ear electrode positioned around left cymba conchae with return to the mastoid. Pulses are paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Sham taVNS unit cymbae conchae/mastoid n=2 Participants We will deliver inactive /sham taVNS via the taVNS unit on the vagus channel with the ear electrode positioned around left cymba conchae with return to the mastoid. No pulses are delivered when pressing trigger, paired with oral feeding during 2 feeds a day. No current will be delivered, and assignment will be blinded. transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	active taVNS crossover to sham taVNS n=2 Participants We deliver taVNS via the taVNS unit with the ear electrode positioned on left tragus or at the cymba conchae with return to the tragus. Pulses are paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). Following 10 days of active stimulation with feeds, if infant is making \< 4ml/kg/day increase in oral feed volume we will cross over to sham taVNS for up to 7 days of twice daily treatment. transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Sham taVNS cross over to active taVNS n=2 Participants We deliver taVNS via the taVNS unit with the ear electrode positioned on left tragus or at the cymba conchae with return to the tragus. No active pulses are paired with oral feeding, for the sham condition during 2 feeds a day. Following 10 days of sham stimulation with feeds, if infant is making \< 4ml/kg/day increase in oral feed volume we will cross over to active taVNS for up to 7 days of twice daily treatment with current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Total n=16 Participants Total of all reporting groups
Age, Continuous	41.2 weeks n=5 Participants	44.6 weeks n=7 Participants	42.8 weeks n=5 Participants	43.6 weeks n=4 Participants	48.6 weeks n=21 Participants	41.5 weeks n=8 Participants	43.5 weeks n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	8 Participants n=8 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	8 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	16 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	7 Participants n=8 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	7 Participants n=8 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: 30 minutes during taVNS paired-feed for 10 days

Population: Crossover arms are exploratory due to the small sample size.

safety : number of participants with episode of Heart rate \< 80beats per minute for 5 seconds, according to the first assigned treatment

Outcome measures

Outcome measures
Measure	active taVNS unit tragus/ cymba conchae n=5 Participants We will deliver taVNS via the taVNS unit with the ear electrode positioned on left tragus or at the cymba conchae with return to the tragus. Pulses are paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	sham taVNS unit tragus/cymbae conchae n=3 Participants We will deliver inactive /sham taVNS via the taVNS unit with the ear electrode positioned around left cymba conchae/ inner tragus with return to the outer tragus. No pulses are delivered when pressing trigger, paired with oral feeding during 2 feeds a day. No current will be delivered, and assignment will be blinded. transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Active taVNS unit cymba conchae/mastoid n=2 Participants We will deliver taVNS via the taVNS unit on the vagus channel with the ear electrode positioned around left cymba conchae with return to the mastoid. Pulses are paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Sham taVNS unit cymbae conchae/mastoid n=2 Participants We will deliver inactive /sham taVNS via the taVNS unit on the vagus channel with the ear electrode positioned around left cymba conchae with return to the mastoid. No pulses are delivered when pressing trigger, paired with oral feeding during 2 feeds a day. No current will be delivered, and assignment will be blinded. transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	active taVNS cross over to sham taVNS n=2 Participants Infants who receive 10 days of active taVNS twice daily with feeds, but have \<4ml/kg/d increase in daily oral feed volume and cross over to alternative treatment of sham taVNS for up to 7 days	Sham taVNS cross over to active taVNS n=2 Participants Infants who receive 10 days of sham taVNS twice daily with feeds, but have \<4ml/kg/d increase in daily oral feed volume and cross over to alternative treatment of active taVNS for up to 7 days
Bradycardia	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 30 minutes during taVNS paired-feed up to 17 days

Population: Crossover arms are exploratory due to the small sample size.

mean number of participants with Neonatal and Infant Pain scale (NIPS) \>3 point increase, indicating worse discomfort according to the first assigned treatment

Outcome measures

Outcome measures
Measure	active taVNS unit tragus/ cymba conchae n=5 Participants We will deliver taVNS via the taVNS unit with the ear electrode positioned on left tragus or at the cymba conchae with return to the tragus. Pulses are paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	sham taVNS unit tragus/cymbae conchae n=3 Participants We will deliver inactive /sham taVNS via the taVNS unit with the ear electrode positioned around left cymba conchae/ inner tragus with return to the outer tragus. No pulses are delivered when pressing trigger, paired with oral feeding during 2 feeds a day. No current will be delivered, and assignment will be blinded. transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Active taVNS unit cymba conchae/mastoid n=2 Participants We will deliver taVNS via the taVNS unit on the vagus channel with the ear electrode positioned around left cymba conchae with return to the mastoid. Pulses are paired with oral feeding, off with rest during 2 feeds a day. Current will be delivered at 0.1milliAmpere (mA) \< perceptual threshold (PT), 500microseconds, 25 Hertz (Hz). transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	Sham taVNS unit cymbae conchae/mastoid n=2 Participants We will deliver inactive /sham taVNS via the taVNS unit on the vagus channel with the ear electrode positioned around left cymba conchae with return to the mastoid. No pulses are delivered when pressing trigger, paired with oral feeding during 2 feeds a day. No current will be delivered, and assignment will be blinded. transcutaneous auricular vagus nerve stimulation: Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.	active taVNS cross over to sham taVNS n=2 Participants Infants who receive 10 days of active taVNS twice daily with feeds, but have \<4ml/kg/d increase in daily oral feed volume and cross over to alternative treatment of sham taVNS for up to 7 days	Sham taVNS cross over to active taVNS n=2 Participants Infants who receive 10 days of sham taVNS twice daily with feeds, but have \<4ml/kg/d increase in daily oral feed volume and cross over to alternative treatment of active taVNS for up to 7 days
Discomfort Scores	1 Participants	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 17 days

Population: Crossover arms are exploratory due to the small sample size.

taVNS in participants who received tragus stimulation and attained full oral feeds (oral intake = or \>130ml/kg/day with weight gain) according to the first assigned treatment