Using nerve stimulation to help premature infants breastfeed better

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance breastfeeding skills in premature or sick term infants by using transcutaneous vagus nerve stimulation (taVNS) to boost motor learning. A total of 10 infants, who are at least 35 weeks gestational age and admitted to the NICU, will receive daily taVNS treatments paired with breastfeeding for up to 14 days. The stimulation will be adjusted to a level that provides a slight tingle without discomfort, coinciding with the infant's latching and sucking during feeds. Data on feeding performance, including weight gain and feeding techniques, will be collected to assess the effectiveness of this intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Infants ≥ 35 weeks post-menstrual age,
* Clinically stable, without significant respiratory support,
* Deemed safe to breastfeed by OT/SLP/lactation,
* Maternal interest in breastfeeding,
* Are not breastfeeding well despite the assistance of a lactation consultant.

Exclusion Criteria:

* Cardiomyopathy,
* Unstable bradycardia,
* Significant respiratory support,
* Absent maternal interest in breastfeeding, or infant or mother with contraindications to breastfeeding such as infantile galactosemia,
* Maternal HIV without adequate viral suppression,
* Maternal illicit drug use.

Where it's running

• Medical University of South Carolina Shawn Jenkins Children's Hospital
  Charleston, South Carolina, United States Recruiting

Study contacts

• Principal investigator: Haley Burdge — Medical University of South Carolina
• Study coordinator: Haley Burdge
• Email: burdge@musc.edu
• Phone: 8432144089

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining oral muscle exercises and bedside reading to help preterm babies feed and build language

  This project tests whether pairing gentle oral muscle exercises with bedside parent reading helps preterm infants (born 23–30 weeks) start oral feeding sooner and improve early language.

  Recruiting Women and Infants Hospital of Rhode Island · Providence, Rhode Island · NCT05861531

• Impact of Body Composition on Feeding in Large for Gestational Age Infants

  This study is testing if a special feeding plan based on body composition can help Large for Gestational Age infants with feeding difficulties.

  Recruiting at 2 sites Nemours Children's Clinic · Orlando, Florida and 1 other locations · NCT04599010

• Wireless MicroPremVitals Button Sensor for the NICU

  This study tests a tiny wireless sensor system to monitor heart rate, oxygen, and temperature in extremely preterm babies in the NICU to see if it works safely without wires.

  Recruiting McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT07732257

• Caffeine in pregnancy: how the mother and baby handle it during delivery

  This study tests how caffeine is processed in pregnant people and how much reaches the baby when given shortly before delivery.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT07570121

• Neonatal data and biobank to understand what influences development in very preterm infants

  This project will collect clinical information and biological samples to see if early biological, clinical, and environmental factors predict short- and long-term development in infants born before 32 weeks or under 1500 g.

  Recruiting University Hospital of Cologne · Cologne, North Rhine-Westphalia · NCT07490912

• Biomarkers in infants with prior neonatal brain injury

  This project will test brain activity and development using games, EEG, and parent questionnaires in infants aged 3–24 months with and without prior neonatal brain injury.

  Recruiting University of Wisconsin, Madison · Madison, Wisconsin · NCT07413900

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.