Trial Outcomes & Findings for NAC +taVNS in IDM Who Are Poor Oral Feeders (NCT NCT04632069)

NCT ID: NCT04632069

Last Updated: 2024-08-29

Results Overview

Difference in the Mean daily change in oral feeding volume(reported in in ml/kg/d) from Day 1-18 days of NAC+taVNS treatment minus Days -14 to 0 (baseline)

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: Day -14 to 0, Day 1 to 18
• Results posted on: 2024-08-29

Participant Flow

Recruitment from 8.12.21 to 3.1.23 in the Neonatal intensive care unit of the Medical University of South Carolina

Participant milestones

Measure	NAC + taVNS NAC will be given via nasogastric tube (n.g.) 75mg/kg/dose or 100mg/kg/dose n.g. q 6h, administered 1h before a feed, for a total of 14 days. taVNS will be administered to left ear during active sucking with 2 daily feedings starting after 4 days of NAC, continuing for 10 days. N acetyl cysteine + vagus nerve stimulation: NAC x 14 days, taVNS x 10 days
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NAC +taVNS in IDM Who Are Poor Oral Feeders

Baseline characteristics by cohort

Measure	NAC + taVNS n=10 Participants NAC will be given via nasogastric tube (n,g.) 75mg/kg/dose or 100mg/kg n.g. q 6h, administered 1h before a feed, for a total of 14 days. taVNS will be administered to left ear during active sucking with 2 daily feedings starting after 4 days of NAC, continuing for 14 days. N acetyl cysteine + vagus nerve stimulation: NAC x 14 days, taVNS x 14days
Age, Continuous	41.1 weeks post menstrual age STANDARD_DEVIATION 1.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
mean daily oral feeding volume of formula or breast milk	47 ml/kg/day STANDARD_DEVIATION 29 • n=5 Participants

PRIMARY outcome

Timeframe: Day -14 to 0, Day 1 to 18

Population: infants of diabetic mothers failing oral feeds in G-tube discussions

Difference in the Mean daily change in oral feeding volume(reported in in ml/kg/d) from Day 1-18 days of NAC+taVNS treatment minus Days -14 to 0 (baseline)

Outcome measures

Measure	NAC + taVNS n=10 Participants NAC will be given via nasogastric tube (n,g.) 75 or 100mg/kg n.g. q 6h, administered 1h before a feed, for a total of 14 days. taVNS will be administered to left ear during active sucking with 2 daily feedings starting after 4 days of NAC, continuing for 14 days. N acetyl cysteine + vagus nerve stimulation: NAC x 14 days, taVNS x 14 days
Daily Oral Feeding Volumes : Difference in Mean Increase	2.1 ml/kg/day po daily change Standard Deviation 0.4

SECONDARY outcome

Timeframe: baseline to 4 days

Population: participants with adequate MRS spectra for analysis

Change in [GSH] by MRS from baseline to day 4 of NAC

Outcome measures

Measure	NAC + taVNS n=8 Participants NAC will be given via nasogastric tube (n,g.) 75 or 100mg/kg n.g. q 6h, administered 1h before a feed, for a total of 14 days. taVNS will be administered to left ear during active sucking with 2 daily feedings starting after 4 days of NAC, continuing for 14 days. N acetyl cysteine + vagus nerve stimulation: NAC x 14 days, taVNS x 14 days
Metabolite Concentrations in Basal Ganglia	0.13 mM Standard Deviation .08

Adverse Events

NAC + taVNS

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	NAC + taVNS n=10 participants at risk NAC will be given via nasogastric tube (n,g.) 75 or 100mg/kg n.g. q 6h, administered 1h before a feed, for a total of 14 days. taVNS will be administered to left ear during active sucking with 2 daily feedings starting after 4 days of NAC, continuing for 14 days. N acetyl cysteine + vagus nerve stimulation: NAC x 14 days, taVNS x 14 days
Cardiac disorders bradycardia	0.00% 0/10 • 36 days bradycardia defined as heart rate \<80beats per minute for \> 5 seconds; emesis

Other adverse events

Measure	NAC + taVNS n=10 participants at risk NAC will be given via nasogastric tube (n,g.) 75 or 100mg/kg n.g. q 6h, administered 1h before a feed, for a total of 14 days. taVNS will be administered to left ear during active sucking with 2 daily feedings starting after 4 days of NAC, continuing for 14 days. N acetyl cysteine + vagus nerve stimulation: NAC x 14 days, taVNS x 14 days
Gastrointestinal disorders emesis per day	20.0% 2/10 • Number of events 2 • 36 days bradycardia defined as heart rate \<80beats per minute for \> 5 seconds; emesis

Additional Information

Dr Dorothea Jenkins

Medical University of South Carolina

Phone: 843-792-2112

Email: jenkd@musc.edu

Results disclosure agreements

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