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Behavioural Intervention

Vagus Nerve Stimulation for Improved Breastfeeding in Premature Infants

N/A
Recruiting
Led By Haley Burdge
Research Sponsored by Medical University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically stable, without significant respiratory support
Must not have
Significant respiratory support
Unstable bradycardia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to help premature or sick term infants improve their breastfeeding skills by using transcutaneous vagus nerve stimulation. They will recruit 10 infants from the NICU at MUSC and provide

Who is the study for?
This trial is for premature infants (≥35 weeks old) in the NICU who are clinically stable and deemed safe to breastfeed. It's also for those not breastfeeding well despite lactation consultant help. Infants with unstable heart rates, significant breathing support needs, or mothers without interest in breastfeeding or with certain health issues can't join.
What is being tested?
The study tests if taVNS treatments paired with daily breastfeeding can improve feeding skills in premature/sick term infants. The non-invasive device stimulates a nerve during feeds to enhance motor learning, aiming to increase successful breastfeeding at discharge.
What are the potential side effects?
Potential side effects of taVNS may include discomfort from electrical stimulation; however, the intensity is adjusted to be just enough for the infant to feel a slight tingle without pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am breathing without significant help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need help with breathing.
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I have an irregularly slow heartbeat that is not stable.
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I have been diagnosed with cardiomyopathy.
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I am pregnant and my HIV is not well-controlled.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adequate volume transfer during breastfeeding
Infant's ability to sustain breastfeeding for a length of time
Targeted motor learning of skills involved in breastfeeding
Secondary study objectives
Frequency of breastfeeding assessed by study specific survey
Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey
Parent satisfaction with infant's ability to breastfeed assessed by study specific survey

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: taVNS treatment groupExperimental Treatment1 Intervention
All 10 infants will receive active taVNS during breastfeeding sessions. There is no randomization or blinding involved.

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Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
973 Previous Clinical Trials
7,399,374 Total Patients Enrolled
1 Trials studying Premature Birth
7 Patients Enrolled for Premature Birth
Haley BurdgePrincipal InvestigatorMedical University of South Carolina
~2 spots leftby Feb 2025
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