FamilyLink and Breastfeeding

NCT ID: NCT03957941

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-26

Study Completion Date

2022-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The central hypothesis guiding this project is that having mothers view live video of their babies while they are pumping increases milk volume, caloric density, and maternal pumping experience.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breastfeeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants will be randomized to the order of Intervention and Control pumping session. Excluding the first pumping session of the day, as the volume is highest at that time and more consistent throughout the rest of the day. All 30 mothers will be asked to A (Control): Pump three times while they are away from their infant without using FamilyLink for video observation of their baby during pumping and B (Intervention): Pump three times while they are away from their infant, while watching their baby via FamilyLink.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The investigator and outcomes assessor will be blinded to the order the mothers were randomized to.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FamilyLink Pumping

Pump three times while away from infant, while watching baby via FamilyLink.

Group Type EXPERIMENTAL

FamilyLink Pumping

Intervention Type BEHAVIORAL

Viewing baby via FamilyLink while pumping

Standard Pumping

Pump three times while away from infant, not watching baby via FamilyLink.

Group Type ACTIVE_COMPARATOR

Standard Pumping

Intervention Type BEHAVIORAL

Not viewing baby via FamilyLink while pumping

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FamilyLink Pumping

Viewing baby via FamilyLink while pumping

Intervention Type BEHAVIORAL

Standard Pumping

Not viewing baby via FamilyLink while pumping

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Mothers of 30 preterm infants (born before 34 weeks gestational age) admitted to the University of California, Davis neonatal intensive care unit (NICU)
* Mother is pumping breastmilk
* Delivery at least 7 days prior
* Mother not an inpatient,

Exclusion Criteria

* Mother has HIV
* Mother without access to a computer, smartphone, or tablet to access FamilyLink
* Infant delivered via surrogacy
* Maternal age outside limit of 18 to 50
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of California, Davis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laura Kair, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California-Davis

Sacramento, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Hoyt-Austin AE, Miller IT, Kuhn-Riordon KM, Rosenthal JL, Chantry CJ, Marcin JP, Hoffman KR, Kair LR. Bonding, Relaxation, Separation, and Connection: Expressing Human Milk While Videoconferencing with the Hospitalized Premature Infant. Breastfeed Med. 2022 Aug;17(8):653-659. doi: 10.1089/bfm.2021.0214. Epub 2022 May 23.

Reference Type DERIVED
PMID: 35605051 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1370355

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Meditation for NICU Moms
NCT03574766 COMPLETED NA
Breast Versus Bottle Study
NCT03704051 COMPLETED
Learning Early Infant Feeding Cues
NCT06127914 NOT_YET_RECRUITING NA
The LATCHING Pilot Project
NCT03442517 COMPLETED NA
Prenatal Breastfeeding Education
NCT04549129 WITHDRAWN NA