Breastfeeding, Exclusive, Feeding; Difficult, Newborn, Premature Birth
Conditions
Brief summary
Investigators aim to improve the skills of premature or sick term infants in breastfeeding by boosting motor learning with transcutaneous vagus nerve stimulation. Investigators will recruit 10 premature, ≥ 35 weeks gestational age, or convalescing sick term infants admitted to the NICU at MUSC to participate in this study. Infants will receive taVNS treatments once a day with breastfeeding's for up to 14 days. Before each treatment, the researcher will determine how much electrical stimulation is needed for the infant to feel a slight tingle without discomfort, and during daily treatment paired with breastfeeding the infant will continue to receive this level of electrical stimulation, coinciding with latching and sucking, repeated over the duration of the feed. Investigators will collect information about the pre- and post-feed weights, the length of time for each feed, and observations of latch, suck, and swallow techniques by the infant from parents and the lactation consultant. Investigators will also evaluate parental satisfaction associated with their infant's ability to breastfeed after taVNS by providing parental satisfaction surveys at the beginning, after 1 and 2 weeks, and at 3 months after the end of the study to assess infants' progress in and maintenance of breastfeeding abilities. If the pairing of breastfeeding with taVNS is able to result in improved outcomes of effective breastfeeding in infants in the neonatal intensive care units, this intervention could be further utilized by NICUs to increase the rate of premature and sick term infants who are successfully able to breastfeed at the time of discharge and maintain breast feeding longer after discharge. This would allow premature infants to acquire the many benefits of breastmilk as well as contribute towards the strengthening of the maternal-infant bond that breastfeeding has been shown to enhance.
Interventions
DEVICEtaVNS soterix device
Soterix is a custom modified, FDA-cleared electrical stimulator that meets the criteria of the FDA for investigational use. Neoleads will be placed in order to deliver electrical stimulation using microcurrent (\<2.5mA) with breastfeeding, on with sucking and swallowing and off with rest for 5 feeds per week for 2 weeks.
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Weeks to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequate volume transfer during breastfeeding | 2 weeks | Measured by pre- and post-feed weights (grams) |
| Infant's ability to sustain breastfeeding for a length of time | 2 weeks | Average length of active feeding at the breast (minutes) |
| Targeted motor learning of skills involved in breastfeeding | 2 weeks | Demonstration of successful latch, suck, and swallow techniques by the infant per LATCH scoring (L= latch, A= audible swallowing, T= type of nipple (inverted, flat, everted after stimulation), C= Comfort of mother during feed, H= Hold/positioning of infant), scoring 0-10 (2 points per question) with 10 being the highest and optimal score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of breastfeeding assessed by study specific survey | 2 months | Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey |
| Parent satisfaction with infant's ability to breastfeed assessed by study specific survey | 2 months | Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey |
| Level of connectedness and social-emotional bond felt by mother towards infant assessed by study specific survey | 2 months | Answers to related questions on taVNS-paired breastfeeding parental satisfaction survey |
Countries
United States
Contacts
CONTACTHaley Burdge
CONTACTDorothea Jenkins
PRINCIPAL_INVESTIGATORHaley Burdge
Medical University of South Carolina
Outcome results
None listed