LIFT: Telemedicine Breastfeeding Support

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03901833
• Other study ID #: 1382496
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 24, 2019
• Est. completion date: March 29, 2024

Study information

• Verified date: June 2023
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: March 29, 2024
• Est. primary completion date: March 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Behavioral:
• Telemedicine Support
Telemedicine intervention

Other:
• Standard of Care
Standard of Care

Locations

Country	Name	City	State
United States	University of California-Davis	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Davis	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experience	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).	One month post-enrollment
Secondary	Time to cessation	Time to breastfeeding cessation (assessed via monthly surveys as no to infant receiving any breast milk in last 24 hours)	Monthly up to 12 months
Secondary	Exclusive breastfeeding cessation	Time to exclusive breastfeeding cessation (assessed via monthly surveys, defined by initiation of formula, water, juice, other liquids, or solid foods)	Monthly up to 12 months
Secondary	Breastfeeding at 3 months	Proportion of infants breastfeeding at 3 months (assessed via 24 hour recall from infant's mother)	3 months
Secondary	Exclusive breastfeeding	Proportion of infants breastfeeding without supplementation with other food or liquids at 3 months (assessed via 24 hour recall from infant's mother)	3 months
Secondary	Individual satisfaction questions	Mean satisfaction on each Interactive Telehealth Satisfaction Scale question	1 month post enrollment

External Links

•   Learn more or sign up for the study here!