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Clinical Trials/NCT03901833
NCT03901833
Completed
Not Applicable

Telemedicine Breastfeeding Support Following Late Preterm Delivery: A Randomized Controlled Trial

University of California, Davis1 site in 1 country56 target enrollmentJuly 24, 2019
ConditionsBreastfeeding

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breastfeeding
Sponsor
University of California, Davis
Enrollment
56
Locations
1
Primary Endpoint
Experience
Status
Completed
Last Updated
last year

Overview

Brief Summary

The central hypothesis guiding this project is that tailored breastfeeding support, that leverages easily accessible telemedicine technologies, can improve breastfeeding outcomes among late preterm dyads. The long-term goals of this project are to improve maternal and child health and reduce health disparities by designing and implementing evidence-based interventions to improve breastfeeding outcomes for this challenging patient population. This study seeks to identify lactation support practices that improve breastfeeding duration and to test the effect of telemedicine breastfeeding support on breastfeeding duration, among the nearly one in ten mothers who deliver late preterm (34-37 6/7 weeks), as this subpopulation of mothers faces the highest rates of premature breastfeeding cessation

Registry
clinicaltrials.gov
Start Date
July 24, 2019
End Date
March 29, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • maternal age 18-49 years
  • late preterm delivery (34-37 6/7 weeks)
  • enrollment up to 1 week postpartum
  • breastfeeding initiated
  • access to a smartphone, tablet, or laptop computer in their home

Exclusion Criteria

  • incarceration
  • inability to communicate in English
  • infant with medical condition compromising breastfeeding (e.g. cleft lip and/or palate).

Outcomes

Primary Outcomes

Experience

Time Frame: One month post-enrollment

Mean score on a modified, 16-item Interactive Telehealth Satisfaction Scale \>48 (corresponding to better than neutral on a 5 point Likert scale, 16 questions).

Secondary Outcomes

  • Time to cessation(Monthly up to 12 months)
  • Breastfeeding at 3 months(3 months)
  • Exclusive breastfeeding cessation(Monthly up to 12 months)
  • Exclusive breastfeeding(3 months)
  • Individual satisfaction questions(1 month post enrollment)

Study Sites (1)

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