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Trial record 1 of 1 for:    late preterm telemedicine
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LIFT: Telemedicine Breastfeeding Support

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ClinicalTrials.gov Identifier: NCT03901833
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
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 (34-36 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

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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, 2021
Estimated Study Completion Date : July 31, 2021

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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • maternal age 18-49 years
  • late preterm delivery (34-36 6/7 weeks)
  • enrollment within 96 hours 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 ClinicalTrials.gov identifier (NCT number): NCT03901833


Contacts
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Contact: Hadley Sauers-Ford, MPH 916-734-4729 hsauersford@ucdavis.edu
Contact: Iesha Miller, MA itmiller@ucdavis.edu

Locations
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United States, California
University of California-Davis Recruiting
Sacramento, California, United States, 95817
Contact: Hadley Sauers-Ford, MPH    916-734-4729    hsauersford@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Laura Kair, MD University of California, Davis

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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03901833    
Other Study ID Numbers: 1382496
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No