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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03901833
Other study ID # 1382496
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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