Working… Menu
Trial record 1 of 1 for:    late preterm telemedicine
Previous Study | Return to List | Next Study

LIFT: Telemedicine Breastfeeding Support

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03901833
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : April 8, 2021
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Breastfeeding Behavioral: Telemedicine Support Other: Standard of Care Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Telemedicine Breastfeeding Support Following Late Preterm Delivery: A Randomized Controlled Trial
Actual Study Start Date : July 24, 2019
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
Experimental: Telemedicine Support
Weekly telemedicine breastfeeding support visits for four weeks, delivered via telemedicine
Behavioral: Telemedicine Support
Telemedicine intervention

Placebo Comparator: Control
Standard of care
Other: Standard of Care
Standard of Care

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Time to cessation [ Time Frame: Monthly up to 12 months ]
    Time to breastfeeding cessation (assessed via monthly surveys as no to infant receiving any breast milk in last 24 hours)

  2. Exclusive breastfeeding cessation [ Time Frame: Monthly up to 12 months ]
    Time to exclusive breastfeeding cessation (assessed via monthly surveys, defined by initiation of formula, water, juice, other liquids, or solid foods)

  3. Breastfeeding at 3 months [ Time Frame: 3 months ]
    Proportion of infants breastfeeding at 3 months (assessed via 24 hour recall from infant's mother)

  4. Exclusive breastfeeding [ Time Frame: 3 months ]
    Proportion of infants breastfeeding without supplementation with other food or liquids at 3 months (assessed via 24 hour recall from infant's mother)

  5. Individual satisfaction questions [ Time Frame: 1 month post enrollment ]
    Mean satisfaction on each Interactive Telehealth Satisfaction Scale question

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03901833

Layout table for location contacts
Contact: Hadley Sauers-Ford, MPH 916-734-4729
Contact: Iesha Miller, MA

Layout table for location information
United States, California
University of California-Davis Recruiting
Sacramento, California, United States, 95817
Contact: Hadley Sauers-Ford, MPH    916-734-4729   
Sponsors and Collaborators
University of California, Davis
National Institutes of Health (NIH)
Layout table for investigator information
Principal Investigator: Laura Kair, MD University of California, Davis
Layout table for additonal information
Responsible Party: University of California, Davis Identifier: NCT03901833    
Other Study ID Numbers: 1382496
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No