Trial Outcomes & Findings for taVNS Paired With Bottle Feeding in Infants Failing Oral Feeds (NCT NCT04643808)
NCT ID: NCT04643808
Last Updated: 2023-10-30
Results Overview
Number of infants who maintained full daily PO intake for 4 days (\>120 ml/kg/day) and gained weight adequate for discharge (\>20 g/day) were classified as 'Responders'.
COMPLETED
EARLY_PHASE1
35 participants
3 weeks
2023-10-30
Participant Flow
Neonatal intensive Care Unit
Participant milestones
| Measure |
taVNS Once Daily
taVNS paired with bottle feeding once daily for 2-3 weeks
transcutaneous auricular vagus nerve stimulation: Microcurrent stimulation delivered to the left tragus, with stimulation 'on' during sucking from a bottle, and 'off' at rest during bottle feeding
|
taVNS Twice Daily
taVNS paired with bottle feeding twice daily for 2-3 weeks
transcutaneous auricular vagus nerve stimulation: Microcurrent stimulation delivered to the left tragus, with stimulation 'on' during sucking from a bottle, and 'off' at rest during bottle feeding
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
21
|
|
Overall Study
COMPLETED
|
14
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
averaged over 7days prior to starting taVNS treatment
Baseline characteristics by cohort
| Measure |
taVNS Once Daily
n=14 Participants
taVNS paired with bottle feeding once daily for 2-3 weeks
Infants born preterm or near term/term HIE infants who failed to make progress in PO volumes, and were clinically determined to require a G-tube due to failure to achieve oral feeds sufficient for discharge from the hospital.
|
taVNS Twice Daily
n=21 Participants
taVNS paired with bottle feeding twice daily for 2-3 weeks
Infants born preterm or near term/term HIE infants who failed to make progress in PO volumes, and were clinically determined to require a G-tube due to failure to achieve oral feeds sufficient for discharge from the hospital.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 post menstrual age in months ofgestation
STANDARD_DEVIATION 4.8 • n=99 Participants
|
42.1 post menstrual age in months ofgestation
STANDARD_DEVIATION 2.8 • n=107 Participants
|
42.8 post menstrual age in months ofgestation
STANDARD_DEVIATION 3.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
change in ml/kg/d po
|
-0.6 ml/kg/d consumed orally (po)
STANDARD_DEVIATION 4.8 • n=99 Participants • averaged over 7days prior to starting taVNS treatment
|
0.03 ml/kg/d consumed orally (po)
STANDARD_DEVIATION 3.6 • n=107 Participants • averaged over 7days prior to starting taVNS treatment
|
-0.23 ml/kg/d consumed orally (po)
STANDARD_DEVIATION 4.1 • n=206 Participants • averaged over 7days prior to starting taVNS treatment
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Responders who achieved full oral feeds and weight gain adequate for discharge
Number of infants who maintained full daily PO intake for 4 days (\>120 ml/kg/day) and gained weight adequate for discharge (\>20 g/day) were classified as 'Responders'.
Outcome measures
| Measure |
taVNS Once Daily
n=14 Participants
taVNS paired with bottle feeding once daily for 2-3 weeks
|
taVNS Twice Daily
n=21 Participants
taVNS paired with bottle feeding twice daily for 2-3 weeks
|
|---|---|---|
|
Number of Infants Who Took All Feeds by Mouth (Responders)
|
8 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe change in ml/kg/d of oral feeds over the 7 days during taVNS-paired feeds
Outcome measures
| Measure |
taVNS Once Daily
n=14 Participants
taVNS paired with bottle feeding once daily for 2-3 weeks
|
taVNS Twice Daily
n=21 Participants
taVNS paired with bottle feeding twice daily for 2-3 weeks
|
|---|---|---|
|
ml/kg/d Increase Over 7d During taVNS
|
3.9 ml/kg/d increase over 7d
Standard Deviation 4.2
|
6.0 ml/kg/d increase over 7d
Standard Deviation 4.16
|
PRIMARY outcome
Timeframe: change from baseline to week 3changes in radial kurtosis diffusion in Corticospinal tracts at the cerebellar peduncles assessed per week of treatment, change from baseline to week 3 reported. Kurtosis is a dimensionless summary statistic that quantifies the amount of non-Gaussianity within the tissue on a scale from 0 to infinity. Higher values indicate greater complexity in the white matter tract. The scale has no title other than diffusion kurtosis.
Outcome measures
| Measure |
taVNS Once Daily
n=9 Participants
taVNS paired with bottle feeding once daily for 2-3 weeks
|
taVNS Twice Daily
n=11 Participants
taVNS paired with bottle feeding twice daily for 2-3 weeks
|
|---|---|---|
|
Neuroplasticity as Measured by the Change in White Matter Tract Integrity Via Fractional Anisotropy
|
0.07 kurtosis units on a scale
Standard Deviation .02
|
0.02 kurtosis units on a scale
Standard Deviation .02
|
SECONDARY outcome
Timeframe: 3 weeks, during taVNS sessionsbradycardic episodes = heart rate \<80 beats per minute for 5 seconds
Outcome measures
| Measure |
taVNS Once Daily
n=14 Participants
taVNS paired with bottle feeding once daily for 2-3 weeks
|
taVNS Twice Daily
n=21 Participants
taVNS paired with bottle feeding twice daily for 2-3 weeks
|
|---|---|---|
|
Number of Episodes of Bradycardia
|
1 bradycardic events
|
0 bradycardic events
|
SECONDARY outcome
Timeframe: 30min treatment sessionPopulation: total number of treatment sessions for all participants
Number of treatment sessions with sustained increase of 3 points in Neonatal and Infant Pain Scale (NIPS) scores from before to during taVNS: NIPS recorded at before, midway, and at the end of each treatment session. NIPS scores range from 0 (no discomfort) to 7 (maximum discomfort). An increase of 3 points on the NIPS scale indicates more discomfort with stimulation.
Outcome measures
| Measure |
taVNS Once Daily
n=228 treatment sessions
taVNS paired with bottle feeding once daily for 2-3 weeks
|
taVNS Twice Daily
n=623 treatment sessions
taVNS paired with bottle feeding twice daily for 2-3 weeks
|
|---|---|---|
|
Number of Treatment Sessions With Sustained Increase in 'Neonatal and Infant Pain Scale' (NIPS) Scores During taVNS
|
3 treatment sessions
|
0 treatment sessions
|
Adverse Events
taVNS Once Daily
taVNS Twice Daily
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Dorothea Jenkins
Medical Univesristy of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place